Please note that the information contained in our CSR is for educational purposes only and is not intended as medical advice.
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Moreau C, Defebvre L, Destée A, Bleuse S, Clement F, Blatt JL, Krystkowiak P, Devos D. (2008). Surgical Treatment of PD. , STN-DBS frequency effects on freezing of gait in advanced Parkinson disease. Neurology. 2008 Apr 16 [Epub ahead of print]STN-DBS frequency effects on freezing of gait in advanced Parkinson disease. Neurology. 2008 Apr 16 [Epub ahead of print]
The purpose of this study was to look at the parameters of DBS-STN settings when PWP have severe gait disturbance or episodes of freezing. The goal of this study was to evaluate if making setting changes would reduce such disturbances. All of the patients who participated had undergone DBS STN within 5 years of the worsening of their motor difficulties and had experienced initial improvement after the surgery. The results of this study suggested that a two step approach to the stimulation parameters may be the best method for controlling the severe gait disturbances and freezing episodes that can be seen in advanced Parkinson’s disease. They suggested that initially a higher stimulator frequency setting (130 Hz) is beneficial with “typical voltage” for optimal motor control but after motor disturbances worsen with time a lower stimulator frequency setting (60 Hz) with higher voltage may show more promise. The authors also offered multiple hypotheses as to why such stimulator changes may be beneficial (e.g. surrounding structures, changes in the STN with disease progression). Further research on stimulator settings was recommended to fully evaluate this treatment option’s efficacy for controlling motor dysfunction in PWP.
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Melamed E, Ziv I, Djaldetti R. (2007). Management of motor complications in advanced Parkinson's disease.. , Mov Disord. 2007 Sep; 22 Suppl. 17:S379-84.Mov Disord. 2007 Sep; 22 Suppl. 17:S379-84.
This article is a summary of the progression of motor complications seen in the early and later stages of Parkinson’s disease as well as how best to manage those symptoms. As discussed in the literature, levodopa is the most common treatment for PD, but approximately 2-5 years after the treatment is initiated the patient often experiences reduced efficacy of the drug and develops adverse motor complications (e.g. “dyskinesias and dystonias”). As the disease progresses and the medications lose efficacy, most PWP will begin to experience “wearing off” phenomenon and increases in the daily need for levodopa. The authors discussed various specific motor phenomenons (on/off, wearing off, delayed on, no-on) that can occur when taking levodopa (we refer the reader to the article for more discussion of the specific phenomenon, these can also be found in the DBS-STN glossary).
In the article there was discussion about the underlying mechanisms for the motor complications/fluctuations that the PWP may experience. It is notable that these mechanisms are not fully understood. Researchers are continuously attempting to better understand these processes as well as create better therapies for the PWP to avoid motor complications or reduced responses to the medication. The authors discussed 2 general hypotheses (central and peripheral) to explain these motor fluctuations. The central mechanism hypothesis suggests that due to disease progression there are changes in the brain (reduced receptors, less sensitive receptors, and poor conversion of the drug in the system) that do not allow the medications to work as effectively as they once did. The peripheral mechanism hypothesis purports that the drug itself may cause changes in the stomach, which affects how much of the drug is available for the brain.
Lastly, the authors gave specific guidelines for medical professionals to manage motor fluctuations related to levodopa. The authors also gave suggestions on how best to improve absorption of levodopa that can be done within the patient’s home (e.g. taking the medication before meals, avoid protein filled meals, not to lie down after ingesting the medication, etc.). Furthermore, they discussed other medical techniques that have shown promise, including surgical interventions (e.g., e.g. thalamotomy, pallidotomy, DBS, and stem cells). This article, like many before it, concludes simply that more research needs to be done on these approaches to best understand and treat motor complications from PD.
**We at DBS-STN do not offer any medical advice in regard to how to take your medications. Any changes in one’s medication regimen should be done only under the advice of your physician. Any questions regarding how best to manage your motor complications should be discussed with your physician.
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Ludwig J, Remien P, Guballa C, Binder A, Binder S, Schattschneider J, Herzog J, Volkmann J, Deuschl G, Wasner G, Baron R.. Effects of subthalamic nucleus stimulation and levodopa on the autonomic nervous system in Parkinson's disease.. , J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):742-5. Epub 2007 Mar 19J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):742-5. Epub 2007 Mar 19
This is a European study that looked at the effect of stimulator or medicinal treatment of PD on the autonomic nervous system (ANS; e.g. system in the body that controls heart rate, blood pressure, bladder control, temperature, etc.) of PWP. The authors looked at PWP with and without DBS as well as at different times of stimulation and medication administration (e.g. immediately after taking it, off vs. on times, etc.). The individuals that underwent DBS-STN were approximately 1-2 years out from the surgery and had significant improvement in their motor symptoms as well as a reduction in the amount of levodopa needed after surgery. The authors found that select ANS functions (enhanced blood flow to the skin, bladder functioning) were positively affected by DBS-STN but in general that the stimulator did not affect blood pressure or cardiac functioning. They also found that levodopa negatively affected select ANS functions (lowered heart rate, lowered blood pressure, increased temperature, decreased blood flow to the skin), which in turn increased problems with orthostatic hypotension (getting dizzy with positional change). The researchers concluded that DBS-STN resulted in improvement in motor functioning, lowered need for PD medications after surgery, and that the symptoms of ANS dysfunction were reduced as compared to the non-stimulated PWP.
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Farris S, Vitek J, Giroux ML. (2008), . Deep brain stimulation hardware complications: The role of electrode impedance and current measurements.. , Mov Disord. 2008 Jan 9 [Epub ahead of print]Mov Disord. 2008 Jan 9 [Epub ahead of print]
The authors of this study began by discussing the improvement of motor symptoms from DBS. However, as we know, this procedure may undergo changes in the level of motor control across time. They discussed that there may be various reasons that DBS changes in efficacy across time, including the hardware of the device itself. In a related finding by these authors, they looked at 466 patients across 7 years and found a rate of 8.1% of those patients had changes in their motor functioning as a direct result of hardware problems (e.g. battery failure, problems with the wires, or misplaced electrodes). They discussed the role of hardware complications as being very important as more and more people are undergoing this procedure and sadly there is little guidance from the manufacturers in regard to technical manuals and there are no strict clinical guidelines to follow in regard to hardware/patient management. The goal of their current study was to follow 4 patients that had hardware complications and how they were best managed for long term efficacy of DBS. The authors went into a great deal of specific stimulator settings (we refer the reader back to the original article for specifics as it is beneficial to read the entire article for related information past the scope of this review) and findings for each patient including a kink in a lead wire, wire fracture, internal wire abnormality, and gap in the wire insulation. It is notable that the patients had their DBS for less than 5 years and after finding hardware problems were treated by either stimulator parameter changes or surgery with resultant returned improvement in their motor symptoms. The authors noted that there are various reasons why a PWP may undergo changes in symptoms related to their PD (e.g. disease progression, hardware failures, medication changes, comorbid illnesses, etc.) but when their patients experienced an acute change in “significant tremor” they found hardware issues best explained these changes. They also noted that it is important to carefully look at the pattern of change in patients, including were there any preceding events that may have caused change (e.g. battery replacement, falls, etc.), what is the time course (e.g. acute or gradual), are the symptoms unilateral or bilateral, do the symptoms change with head or body positioning, is there an unusually short length of time before battery replacement (e.g. short in the wires), and what specific symptoms are increasing (e.g. tremor, paresthesia, surge sensations, etc.). The authors concluded that there should be various clinical protocols in place for medical management of PWP. As there are limited resources in this area for clinicians, the authors whom provide a great deal of patient care for PWPs, provided a “clinical pathway for DBS hardware monitoring” in an attempt to improve the medical management for other clinicians that may be struggling with similar hardware issues with their patients as well.
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Wider C, Pollo C, Bloch J, Burkhard PR, Vingerhoets FJ. (2007). Long-term outcome of 50 consecutive Parkinson's disease patients treated with subthalamic deep brain stimulation.. , Parkinsonism Relat Disord. 2007 Sep 5 [Epub ahead of print]Parkinsonism Relat Disord. 2007 Sep 5 [Epub ahead of print]
The authors of this study from Switzerland present the long term data (5 year follow-up) of 50 patients with Parkinson’s disease that underwent DBS-STN. It is notable that the patients in this study, as compared to others in the literature, were older (age = 64.9). All patient data was evaluated and 34% of the original 50 patients had died by the five year mark. The causes of death were infection (not directly related to the surgery), cancer, heart attack, embolism, anaphylactic shock, and suicide. All of the patients that died had good motor outcome from their surgery and did not generally differ from the remaining participants. The remaining patients also had improvement with their motor functioning with the stimulator on in the areas of dyskinesias, reduced “off” time, and tremor. Specific details regarding changes (good and bad) were included in the article. The results were less positive in regards to motor testing without medication, suggesting that disease progression continues and that the stimulator may not be as protective as originally thought. For many of the patients, there was also a reduced need for medications throughout the 5 years as compared to what they took prior to the surgery. It is notable that almost 30% of the patients did not take any PD medication after their surgery. The authors found that patients required more stimulation changes immediately after surgery than they did within the five years and the stimulation voltage increased across time. Patients typically had battery changes around 4 years after surgery. Adverse events immediately after the surgery included acute confusion (22%), seizure (2%), and hyperventilation during surgery (2%). Later adverse events were also well documented in the article and included; orthopedic injury (48%; fractures/arthritis; thought to be due to PD vs. the surgery itself), dementia (30%), depression (22%), misplacement of electrodes (8%), infection (8%), and seizure (2%). It should be noted that there was no specific discussion of speech testing or change within this study, which is important as other studies are finding changes in that area. The authors concluded that DBS-STN was beneficial and efficacious in motor testing at the 5 year follow-up but that the disease still progressed and caused patient symptoms to worsen over time. This study is important for patient’s considering as well as have undergone the DBS-STN procedure to allow the PWP to make informed choices about their medical conditions. Studies from the United States will soon be coming up, which will be interesting to see if similar results are found.
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Klostermann F, Ehlen F, Vesper J, Nubel K, Gross M, Marzinzik F, Curio G, Sappok T. (2007). Effects of subthalamic deep brain stimulation on dysarthrophonia in Parkinson's disease.. , J Neurol Neurosurg Psychiatry. 2007 Aug 31; [Epub ahead of print]J Neurol Neurosurg Psychiatry. 2007 Aug 31; [Epub ahead of print]
This study began by discussing the mixed findings in the literature regarding speech and DBS-STN. It was noted that it is likely that the different findings are due to the different measures used to evaluate speech (machine, speech therapist, patient, physician, etc.) as well as what is classified as “speech” (broad or specific). Therefore it was the goal of their paper to look at speech from multiple perspectives (patient, physician, speech therapist, and “technical measures”). It is notable that this study was conducted in Germany on long-term patients with DBS-STN. They found that motor symptoms improved after DBS-STN. The authors also found that speech was notably worse during stimulation than without as rated by the patients, physicians, and speech therapists. In regard to the technical measures of speech, the authors found that specific measures of speech improved during stimulation (voice tremor, duration of phonation for a vowel, number of syllables in a set reading time, and lower pause time while reading) . The authors concluded that DBS-STN improved specific motoric “speech subfunctions” that are due to Parkinson’s disease itself, but that these subfunction improvements do not equate to noticeable overall improved speech for the patient. The authors then discussed possible etiology of worsened speech due to DBS-STN (spread of the stimulation to surrounding areas, and direct stimulation of the STN). Limitations of this study included that drug-stimulation effects were not evaluated, the patients were long term, and the etiology of the difficulties were speculative. Limitations in this area of study as concluded by the authors include that some aspects of speech are difficult to measure with technical measures and the true measure of someone’s speech being intelligible after DBS-STN is if someone else can truly understand what that PWP is saying. Future research must incorporate the perception of the PWP and family in regard to quality of speech after DBS-STN for a true measure of this adverse side effect of this overall beneficial surgery.
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D'Alatri L, Paludetti G, Contarino MF, Galla S, Marchese MR, Bentivoglio AR. (2007). Effects of Bilateral Subthalamic Nucleus Stimulation and Medication on Parkinsonian Speech Impairment. , Journal of Voice. Mar 15; [Epub ahead of print].Journal of Voice. Mar 15; [Epub ahead of print].
According to the authors, some of the most common features of the speech difficulties associated with Parkinson's disease included flat tone, hypophonia (low volume), “variable rate,” small bursts of speech, and a “harsh or breathy voice.” They also pointed out that there is controversial literature documenting speech deficits after PWP are treated with DBS-STN. So, they set out to measure speech in PWP, with detailed measures of speech (more than just one question of the UPDRS), after DBS-STN. 12 Italian patients were studied that underwent bilateral DBS-STN. It is notable that there was significant improvement in motor functioning after DBS-STN combined with medications. The authors did not find a difference in the quality of the patient’s speech based on the one question of the UPDRS that addresses speech. They did find that there was some improvement in specific vocal areas (vocal tremor and a specific action by a muscle used in talking) when measured by multiple precise vocal instruments after DBS-STN and with medications. However, this did not represent a meaningful functional change for the patients, as they continued to have difficulties talking without difficulty. This study represents one of the first to look closely at speech in PWP after DBS-STN. They used more detailed voice measures in an attempt to look further into a problem many of our readers have found and discussed with us. This study clearly shows that more research needs to be done focusing on speech after DBS-STN with more patients as well as utilizing more specific voice tools than one question on the UPDRS to measure speech changes after this type of treatment.
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Kathy Dujardin, PhD, Pascal Sockeel, PhD, David Devos, MD, PhD, Marie Delliaux, PhD, Pierre Krystkowiak, MD, PhD, Alain Deste´e, MD, PhD, and Luc Defebvre, MD, PhD (2007).. Characteristics of Apathy in Parkinson’s Disease.. , Movement Disorders, Vol. 22, No. 6, 2007, pp. 778–784.Movement Disorders, Vol. 22, No. 6, 2007, pp. 778–784.
The authors of this study wanted to look at apathy among people with Parkinson’s disease (PWP). They describe apathy as having reduced participation in tasks that one used to enjoy, difficulty initiating activities, feeling indifferent, and having little expression or feeling “flat.” The authors wanted to evaluate an apathy scale, possibly identify if there is a specific “apathy profile” for PD, as well as to evaluate if depression, cognitive decline, or disease severity affected apathy. Approximately 1/3 of the PWP (none had DBS) in this study were classified as apathetic compared to less than 2% of the non-PD control group. Other research studies have suggested that the range of PWP that have apathy is 16-38%. The apathetic PWP also had more depression and cognitive impairment than the non-apathetic PWP.
One aspect of apathy that was measured revealed that the PWP showed less activity and less initiation than the non-pd group. They also found that PWP who had “fluctuating” motor symptoms or dementia demonstrated a flat affect that was not as evident with the non-PD group or the other PD groups (non-demented, constant motor symptoms). The researchers found that impaired cognitive state was more predictive of apathy than severity of motor dysfunction. The authors readily noted that there are many similar symptoms between depression and apathy but they classify them as distinct entities, which suggests that clinicians and researchers should use appropriate assessment tools to gain a clear understanding of both depression and apathy in PWP.
In the introduction as well as the conclusion of the paper, the authors discuss in detail the role of the frontal lobe (frontal portion in the brain) in apathy and suggest that apathy is not solely related to motor dysfunction and that additional therapies focusing on that area of the brain may improve quality of life in PWP. These authors as well as others discuss the importance of monitoring apathy as well as depression within the PD population, as some studies suggest that both can be a side effect of DBS-STN. It is clear that more research is needed to study both apathy and depression to best treat PWP with and without DBS.
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Vesper, J., Haak, S., Ostertag, C., & Nikkhah, G. (2007).. Subthalamic nucleus deep brain stimulation in elderly patients--analysis of outcome and complications. , BMC Neurology. Mar 16; 7: 7.BMC Neurology. Mar 16; 7: 7.
The authors of this study readily acknowledged the benefit of DBS and set out to examine if there were differences in the successes as well as adverse event rates for DBS in an older (65+) and younger (<65) PD population. Both groups showed improvement in their motor scores across various points up to 24 months from surgery. Both groups also had improved quality of life and reduced need for medication after surgery. Immediately after surgery, the younger group had more improvement than the older group in completing tasks independently within the home. However, that difference was small and disappeared by the 6-month follow up. In regard to adverse events, it should be noted that there were few severe complications in either group. Nonetheless, the older group had more infections (4 vs. 1 out of 73) and a higher death rate (5 vs. 2) than the younger group. The authors concluded overall that DBS was effective for both age groups suggesting that there need not be an age limit for DBS. They suggested that both groups be screened for appropriate candidacy for DBS, especially as the older adults had more adverse infections than the younger group. The authors also noted that as DBS continues to be a treatment option in older adults that the group should be followed as long term effects are not as well studied in the literature.
Last month we reviewed an article (Derost et al., 2007) also addressing younger versus older adults in regard to effectiveness of DBS. It should be noted that the previous study used more measures, specifically related to Quality of Life, which may explain the difference in findings of these two studies. All else within the studies were comparable and suggestive that DBS is effective for both young and older adults with PD.
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Derost PP, Ouchchane L, Morand D, Ulla M, Llorca PM, Barget M, Debilly B, Lemaire JJ, Durif F.. DBS-STN appropriate to treat severe Parkinson disease in an elderly population?. , Neurology, 68(17):1345-55IsNeurology, 68(17):1345-55Is
This study looked at the age of patient’s undergoing DBS STN and if there is a difference (short and long term) in efficacy, adverse events, or PD symptoms between an older (65+) and younger (<65) group of people with Parkinson’s disease. Patients were tested 1 month prior to surgery and 3, 6, 12, and 24 months post surgery with various measures. The authors found that acutely both groups experienced significant motor improvement from DBS STN. Younger patients had more improvement in quality of life related to mobility, activities of daily living, stigma, cognition, and communication as compared to the older group. These areas generally stayed the same or slightly worsened for the older group. Both groups had a reduction in their levodopa dose and stimulation parameters were not different between the groups. The most common adverse events for both groups was worsened dysarthria, weight gain, and transient mood elevation (hypomania improved within weeks after surgery). There were no significant differences between the groups in regard to adverse events. All adverse events are listed in the article. It is notable that both groups did not experience significant cognitive change after DBS STN. Overall the authors concluded that DBS STN is effective in the short and long term for motor symptoms of both young and older patients but that younger patients may experience more benefit in regard to quality of life than their older counter parts
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Winge, K., Kroyer Nielsen, K., Stimple, H., Lokkegaard, A., Jensen, S. and Werdelin, L. Lower Urinary Tract Symptoms and Bladder Control in Advanced Parkinson’s Disease: Effects of Deep Brain Stimulation in the Subthalamic Nucleus.. , Movement Disorders 2007, 22(2), 220-225.Movement Disorders 2007, 22(2), 220-225.
This article was a prospective study looking at the short-term effects of DBS STN on problematic bladder symptoms commonly seen in patients with PD. These bladder problems are often due to the disease or medication side effects. This study looked at patient’s report as well as direct measurement of bladder function prior to surgery and within 6 months after surgery. Patients had improvement in their motor symptoms (UPDRS motor score and dyskinesia) and in overactive bladder symptoms. However, they found that patients report of being “bothered by” their bladder symptoms initially decreased but then worsened as time went on after DBS STN. Two possibilities explain the increase in patient report of worsened symptoms at the 6 month point. The first possibility is that patients may have had such improvement in their motor symptoms due to surgery that previously less bothersome symptoms (e.g. nonmotor symptoms) are more evident. The second possibility is that DBS STN had worsened the way people cope with their illness or situation. It is difficult to say which possibility best explains the decline, as there is not much research on changes in coping strategies as PD progresses. This study is in direct contrast to two other studies mentioned on our site (Finazzi-Agro et al. & Seif et al.), but the participants in the current study and the time since the DBS surgery was different. The authors of this study only looked at bladder problems up to 6 months after DBS STN, whereas the other studies looked at long-term bladder dysfunction (both studies showed significant improvement). This suggests that with time DBS STN likely has a beneficial effect on the bladder functioning, but that it may not be as evident within the first six months after surgery. The ideal study would look at both short term and long term gain in bladder function before and after DBS STN, which has yet to be done in the literature.
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Friedman JH, Brown RG, Comella C, Garber CE, Krupp LB, Lou JS, Marsh L, Nail L, Shulman L, Taylor CB; Working Group on Fatigue in Parkinson's Disease. (2007). Fatigue in Parkinson's disease: a review. Movement Disorders. 2007 Feb 15;22(3):297-308. NonMotor Symptoms. ,
This article was a review of the literature discussing fatigue in PD. Fatigue has been recently more recognized in PD patients. Fatigue is not currently measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) but is often experienced by the PWP. The UPDRS is one of the most common instruments used by treatment providers to monitor PD symptoms; future revisions have indicated that fatigue will be included in the assessment tool. It is unclear why PD patients experience fatigue. Studies have shown that fatigue in PD is not always related to disease severity or motor dysfunction. Some PWP indicated that they felt fatigued prior to the diagnosis of PD. Studies have shown that fatigue often co-occurs with other nonmotor symptoms, which makes it difficult to tease out if one is causing the other (e.g. sleep problems, depression, anxiety). Fatigue has been studied in animal models and may be related to dopamine depletion (a chemical in the brain whose depletion causes PD symptoms). Studies have shown that exercise in those animals had less dopamine loss. Researchers have also studied fatigue in cancer and multiple sclerosis to help understand fatigue in PD. It is also unknown what causes fatigue in those diseases as well. In cancer studies aerobic exercise was shown to improve fatigue but researchers don’t fully understand the process of why. Also in multiple sclerosis they found that fatigue was linked to patient perceptions of their general health and control over their disease. More research needs to be done to better understand fatigue in PD. There currently are not consistent answers as to why the PWP does or does not experience fatigue or how best to treat it.
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Stefani, A., Lozano, AM., Peppe, A., Stanzione, P., Galati, S., Tropepi, D., Pierantozzi, M., Brusa, L., Scarnati, E., & Mazzone, P.. Bilateral deep brain stimulation of the pedunculopontine and subthalamic nuclei in severe Parkinson’s disease. , Brain, 2007 Jan 24; [Epub ahead of print]Brain, 2007 Jan 24; [Epub ahead of print]
This study looked at concurrent stimulation of two areas within the brain (subthalamic [STN] and pedunculopontine nuclei [PPN]) to treat symptoms of PD. The authors found that stimulation of the PPN added to benefits of DBS-STN specifically in the areas of gait, postural instability, and increased efficacy of postsurgical medications. The patients were only followed for a short time afterward so long term adverse events are unknown. The only adverse event noted was a parasthesia (unusual feeling, burning, itching, etc.) in the legs at higher stimulation frequencies. Follow up studies from this group are on-going.
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Deuschl, G.,Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, & Voges J (2006). A Randomized Trial of Deep-Brain Stimulation for Parkinson's Disease.. , 355, 9, 896-908355, 9, 896-908
Intro
This study looked at treatment efficacy in patients with PD treated with deep brain stimulation and medications to those patients treated only with medication.
Who were the patients in the study and what were they asked to do?
There were 156 patients in this study between 2001 and 2004. Patients were carefully screened for appropriateness for surgical candidacy before being assigned to surgery or medication only treatment groups. The authors created 78 pairs to be treated so they could evaluate of the pair, which had a better response to their therapy. There were 78 patients that underwent bilateral DBS-STN and 78 patients that were treated with the best medication practices available at that center. The patient's were not different demographically (age: around 60, Duration of levodopa treatment 13-13.8 years, 50 males in each group, and similar Hoehn and Yahr stages). Patient's were asked to complete the PDQ-39 (Parkinson's Disease Questionnaire), Schwab and England Scale (test of functioning), Mattis Dementia Rating Scale (test of cognitive functioning), Montgomery and Asberg Depression Rating Scale and the Brief Psychiatric Rating Scale (both for neuropsychiatric functioning), Medical Outcomes Study 36-item Short Form General Health Survey (SF-36; quality of life measure), and were evaluated by the neurologist on the Unified Parkinson's Disease Rating Scale (UPDRS). Patients were also asked to keep a diary of their mobility throughout the study before and after treatment initiation.
Who were the researchers?
The research in this study was conducted at 10 academic centers in Germany and Austria
What did the researchers find?
The researchers found that those patients treated with neurostimulation had more improvement in motor symptoms, dyskinesias, general health status, quality of life, mobility, activities of daily living, emotional well-being, stigma, and bodily discomfort as compared to those only treated with medication. Activities of daily living slightly declined in the medication only group. There were no improvements or differences between the groups in terms of social support, cognition, depression, or communication. According to the diaries kept by the patients, the group treated with neurostimulation showed significant improvement in their objective rating of their immobility, time of mobility w/o dyskinesia, time spent sleeping, and decreased time of bothersome dyskinesia and mobility.
Were there any serious adverse effects of treatment?
There were a total of 13 severe adverse events recorded between the groups (10 neurostimulation and 3 medication only). Three patients died in the neurostimulation group (1 from a bleed in the brain during surgery, 1 from pneumonia, and 1 suicide). In the medication group 1 patient died in a motor vehicle accident while in a psychotic state. The other events resolved without complication. There were a total of 173 non-severe adverse events in 89 patients (39 stimulator and 50 medication) between the groups. Many of these events are known medical problems due to advanced Parkinson's disease.
What were the author's conclusions?
The authors concluded that their study is the first controlled clinical trial to focus on effects of treatment in regard to not only motor symptoms but also quality of life in patients with advanced PD under the age of 75. They found that those patients treated with DBS-STN had more improvement than those patients only treated with medication.
Why was this study important?
This study is important to evaluate the efficacy of DBS on difficulties with motor functioning as well quality of life in patients with PD. DBS is a treatment modality that has known risks but it is vital to have studies that document its efficacy and symptomatic benefits as compared to other treatment options so that patients and clinicians can make informed choices in regards to treating Parkinson's disease.
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Deuschl, G.,Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR. A Randomized Trial of Deep-Brain Stimulation for Parkinson's Disease. , 355, 9, 896-908355, 9, 896-908
Intro
This study looked at treatment efficacy in patients with PD treated with deep brain stimulation and medications to those patients treated only with medication.
Who were the patients in the study and what were they asked to do?
There were 156 patients in this study between 2001 and 2004. Patients were carefully screened for appropriateness for surgical candidacy before being assigned to surgery or medication only treatment groups. The authors created 78 pairs to be treated so they could evaluate of the pair, which had a better response to their therapy. There were 78 patients that underwent bilateral DBS-STN and 78 patients that were treated with the best medication practices available at that center. The patient's were not different demographically (age: around 60, Duration of levodopa treatment 13-13.8 years, 50 males in each group, and similar Hoehn and Yahr stages). Patient's were asked to complete the PDQ-39 (Parkinson's Disease Questionnaire), Schwab and England Scale (test of functioning), Mattis Dementia Rating Scale (test of cognitive functioning), Montgomery and Asberg Depression Rating Scale and the Brief Psychiatric Rating Scale (both for neuropsychiatric functioning), Medical Outcomes Study 36-item Short Form General Health Survey (SF-36; quality of life measure), and were evaluated by the neurologist on the Unified Parkinson's Disease Rating Scale (UPDRS). Patients were also asked to keep a diary of their mobility throughout the study before and after treatment initiation.
Who were the researchers?
The research in this study was conducted at 10 academic centers in Germany and Austria
What did the researchers find?
The researchers found that those patients treated with neurostimulation had more improvement in motor symptoms, dyskinesias, general health status, quality of life, mobility, activities of daily living, emotional well-being, stigma, and bodily discomfort as compared to those only treated with medication. Activities of daily living slightly declined in the medication only group. There were no improvements or differences between the groups in terms of social support, cognition, depression, or communication.
According to the diaries kept by the patients, the group treated with neurostimulation showed significant improvement in their objective rating of their immobility, time of mobility w/o dyskinesia, time spent sleeping, and decreased time of bothersome dyskinesia and mobility.
Were there any serious adverse effects of treatment?
There were a total of 13 severe adverse events recorded between the groups (10 neurostimulation and 3 medication only). Three patients died in the neurostimulation group (1 from a bleed in the brain during surgery, 1 from pneumonia, and 1 suicide). In the medication group 1 patient died in a motor vehicle accident while in a psychotic state. The other events resolved without complication.
There were a total of 173 non-severe adverse events in 89 patients (39 stimulator and 50 medication) between the groups. Many of these events are known medical problems due to advanced Parkinson's disease.
What were the author's conclusions?
The authors concluded that their study is the first controlled clinical trial to focus on effects of treatment in regard to not only motor symptoms but also quality of life in patients with advanced PD under the age of 75. They found that those patients treated with DBS-STN had more improvement than those patients only treated with medication.
Why was this study important?
This study is important to evaluate the efficacy of DBS on difficulties with motor functioning as well quality of life in patients with PD. DBS is a treatment modality that has known risks but it is vital to have studies that document its efficacy and symptomatic benefits as compared to other treatment options so that patients and clinicians can make informed choices in regards to treating Parkinson's disease.
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Moro, Poon, Lozano, Saint-Cyr, & Lang. Subthalamic nucleus stimulation: improvements in outcome with reprogramming. , Arch Neurol. 2006 Jul 10; Epub ahead of printArch Neurol. 2006 Jul 10; Epub ahead of print
Note from the reviewers at The Parkinson Alliance: The following Current Science Review was made intentionally lengthy as it is our opinion that the area of DBS programming is a vital challenge to the PD community and this article expressly addresses these concerns. We hope that you read it with as much interest as we did. This article discusses issues relevant to patients with DBS. The authors discuss that DBS-STN is an effective treatment for PD; however, it does not come without significant cost of money, time, and well-trained professionals. Treatment with DBS can be challenging in that it requires professional familiarity with programming of the device as well as ability to modify medications to treat PD. Similarly to other areas involving DBS, there are no guidelines for DBS programming or specific qualifications to be a programmer, which can be at the expense to the patient. This article suggests that such guidelines and training would help to promote clinical efficacy, battery life, and negative side effects associated with the programming. The authors suggest that currently the task of programming is given to various individuals with various levels of training. They then went on to cite an example of postoperative care at Toronto Western Hospital Movement Disorders Program (authors affiliated with this program include: Drs. Moro and Lang, and Ms. Poon), including hiring a movement disorder neurologist that took over the postoperative care of their patients. This doctor reportedly completed the majority of the programming as well as the medications adjustments based on the individual patient responses to both the stimulator and the medication management. With the changes they made they expressed an interest to evaluate the efficacy of the system, which they had set up. Their initial hypothesis was that the improvements they made to their postoperative care would result in improved patient response for new patients as well as patients that were reportedly stable following their older system.
They studied 44 patients with PD (only 1 patient had surgery outside of their facility) that had DBS STN for at least one year. All patients had the same stimulator and underwent postoperative MRI to confirm the placement of the electrodes. Their "old method" involved programming that was completed 2-3 weeks after surgery, off medication, and staying overnight at the hospital. Patients then went through testing of all electrode sites on each side (if bilateral stimulation) and effects were noted (method is listed specifically in this article). After the "optimal contact" was located on each side then a combination of trials were conducted to evaluate additional efficacy. Patients continued to have additional adjustments made over the course of the following 3 months (daily or weekly). The authors noted that a supervising movement disorder neurologist discussed the setting parameters with the individual making them, but that the neurologist did not "directly observe" all of the effects.
They found that regardless of using the old or new method, patients undergoing the surgery had improvement on the majority of outcome measures administered (e.g. UPDRS, dyskinesia disability score, off duration score, and levodopa equivalent daily dose). According to the authors, the original 44 patients underwent "reprogramming" (new method) at a routine follow up appointment. Patients were evaluated in their off state by the movement disorder neurologist (method is listed specifically in this article, but includes the UPDRS) and then went through reprogramming. The authors noted that the voltage of the stimulator was slightly lower than that needed to produce "disabling dyskinesias." Medication adjustments were then made based on the patient experienced symptoms after the reprogramming. Patients were kept at the hospital setting for 1-2 hours in the event of delayed adverse events (e.g. worsened dyskinesia, general worsening). The authors reported that they kept patients from out of town for a few days for monitoring and those that lived in Toronto could go home but were kept in close phone contact over the course the following few days. Patients were reassessed at a minimum of two times over the course of 14 months after the reprogramming for any additional changes in programming or medications. The authors were interested in changes in patient UPDRS scores.
They found that patients could be divided into three groups, 1. Those that experienced improvement in symptoms (N=24, 54.6%), 2. those with no significant change (N=16, 36.4%), and 3. those that worsened (N=4, 9.1%). The authors found that those that improved (Group 1) tended to be younger, had better preoperative UPDRS motor scores, and worse dyskinesia duration. All patients in Group 1 had stimulator setting changes. Many of these individuals experienced improvement right away in the areas of "resting tremor, rigidity, and bradykinesia." A little over half of these patients developed stimulator induced dyskinesias (SID) after the reprogramming, all of which were managed over the course of 1-2- weeks by either stimulator adjustments or medication changes. On average these patients were seen five times within 14 months (range was 1-16 visits). The patients seen fewer times generally had difficulties coming into the office for follow-up but were contacted via phone for continued contact. Typical areas of improvement after reprogramming included reduced freezing, walking difficulties, dyskinesia disability scores, and levodopa equivalent daily dose. Improvements were not seen in the areas of speech and falling. Only five (31.2%) of the patients in Group 2 required stimulator-setting changes. This group did not evidence significant change and on average were seen 3 times over the 14 months (range 1-8). Of the four patients in Group 3, all experienced worsening in speech and gait, which required changing their settings back to the original values.
The authors concluded this article by noting that their hypothesis for better care with the involvement of a movement disorder specialist was correct in more than half of the patients studied. They highlighted the need for a movement disorder neurologist was necessary as the direct observation of parameter settings and patient responses was beneficial in determining additional settings as well as necessary medication changes. They also noted that need in the medical field for more neurologist trained in movement disorders that is capable of managing patients that have undergone DBS. The authors opined that this neurologist has to have a good balance between programming and medication management of patients to improve general clinical care and possibly reduce the need for medications. The authors indicated that the management of patients treated with DBS does not necessarily have to be hard if a movement disorder neurologist know the benefits, adverse effects, and interactions of the stimulator and medications used to treat PD. The authors suggested that the parameters and dosages of necessary medications typically do not change much over time once optimization is established. The authors suggested that a movement disorder neurologist is also mandatory in treating SID, which the exact method to do so is discussed in the article. They also discussed hypothesis as to why Groups 2 and 3 may not have experienced improvement as compared to Group 1. They also discussed the limitations to their study, which they did not feel affected the results they found. The authors end the article by noting that it is very important to have a movement disorder neurologist affiliated with patients undergoing DBS for at least the first few months after surgery for the best possible optimization of treatment that they can receive.
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Schupbach, W. et al. Stimulation of the subthalamic nucleus in Parkinson's disease: a 5 year follow up. , 2005 Dec;76(12):1640-42005 Dec;76(12):1640-4
This article discusses the results of 37 patients with PD that underwent bilateral DBS-STN at a clinic in France. Patients were evaluated at 1 month prior to surgery and 6, 24, and 60 months after surgery. They had strict criteria for inclusion of patients for surgery and had attrition of 6 patients by the end of the study (5 deaths, 1 relocated). They found that the patients had more motor improvement with stimulation and levodopa combined versus either treatment alone. They also found less dyskinesias and less need for levodopa, but that the benefit decreased across time. Patients also had improvement in their activities of daily living at the 6 month point, which was lost at the later testing times.
Scores on depression and cognitive screening remained the same across testing through 24 months, but performance on a cognitive screening measure began to worsen at the 60 month evaluation. Their patients did not experience permanent adverse events during the 5 year trial but had various transient events (e.g. emotional fluctuations, urinary retention, eyelid opening difficulties, weight gain). A total of 13 stimulators had to be replaced in the group of patients due to low power (anticipated or experienced) in the battery. The authors listed multiple side effects of intermittent stimulation due to the battery. One of the limitations of this article was that there was no control group of patients with PD to compare to those who underwent DBS-STN. The authors suggest that regardless of a control group there was sustained improvement five years after DBS-STN. They also suggested the possibility of neuroprotective factors of DBS-STN but noted the literature is mixed and mostly completed on animal models. They concluded by suggesting more long term studies to measure the efficacy and possible protective factors of DBS-STN.
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Benabid AL, Chabardes S, Seigneuret E. Deep-brain stimulation in Parkinson's disease: long-term efficacy and safety - What happened this year. , 2005 Dec; 18(6):623-302005 Dec; 18(6):623-30
These authors reviewed 260 articles from 2/04-3/05 involving PD and DBS looking at what researchers have covered and discovered over a year. It should be noted that this article is not a meta-analysis of the literature but simply a review of content and new discoveries. They discuss that the debate over neuroprotective factors, methodology, and placement continue to be controversial issues. The authors noted that in the reviewed articles there is consensus in regard to beneficial effects of stimulation, stability of effects, inclusion criteria, that other conditions may not respond to stimulation, and that stimulation mimics the effects of ablative surgery as well as dopatherapy. They indicated that patients undergoing brain stimulation experienced improvement in gait, balance, and sleep. They reported that quality of life is greatly linked to improved motor symptoms and not as much to improved cognitive or social difficulties, which is not surprising as the stimulation treatments are not purported to improve cognition or social support. The authors completed a cost analysis and found that over the course of 5-7 years that surgical options are cheaper than medications. They discussed the debate regarding stimulator placement, which continues as the studies looking at placement are usually completed on small groups, there are team differences (sites have different methods, outcomes, etc. which makes it hard to compare to each other), patients may not have severe symptoms, and research has shown between the placement sites (STN vs. GPi) a lack of difference on various measures. This article also discussed other diseases that are under review for treatment with DBS (Essential tremor, Obsessive Compulsive Disorder). The authors also discussed side effects of surgery (hypophonia, swallowing, weight gain) as well as surgical complications (stroke 1.15%) due to infections, misplaced leads, and hardware problems. The article also mentions psychological complications such as increased apathy yet mildly improved depression. It is unclear why there are psychological complications such as is it due to the surgery, improper programming, poor stimulator placement, or poor patient selection criteria. Overall they concluded that DBS has been shown to be a reliable and valid treatment with stable effects. However, they stated that the debate sadly continues regarding very important information for DBS (location, subcomponents of the surgical procedures, side effects, questionable neuroprotective effects, and the exact mechanism of action) and suggested that these problems will only be solved with methodological improvement.
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Neurology
Frysinger RC, Quigg M, & Elias WJ. (2006). Bipolar deep brain stimulation permits routine EKG, EEG, and polysomnography. Neurology, Jan 24;66(2):268-70Jan 24;66(2):268-70
This article discussed medical complications/issues of two DBS-STN patients that required additional "electrodiagnostic procedures" (procedures that measure electrical impulses in the body) for other medical conditions. The authors frankly discuss that DBS-STN is being used more often for PD as well as other conditions and that the population that undergoes DBS is getting older and likely will require other tests (EEG for brain activity, EKG for heart activity, Polysomnography for measurement of multiple body functions during sleep) for other non-PD medical conditions. As the DBS stimulator is electrical it tends to distort the electrical recording of the EEG and EKG so the data is not as interpretable as when the patient does not have a DBS stimulator. Obviously, when a patient requires an EEG or EKG the patient and doctor want the best possible recordings for correct diagnosis for treatment of the "other" condition being evaluated. The two patients discussed in this article had successful DBS surgery (one bilateral then other unilateral) but as they aged needed an EKG and an EEG for various reasons. The authors found that when the DBS was set at bipolar stimulator settings there was little to no effect on the EEG, EKG, and sleep studies. However when the DBS was set at monopolar settings there was a lot of interference with both EEG and EKG, to the point it was uninterpretable. This study is very important for DBS patients as the alternative to bipolar or unipolar setting changes during an EEG or EKG would be to turn the stimulator off, which also causes problems for the testing (tremor effects can distort other electrical tests) as well as for the patient (changes may cause discomfort or inability to walk for up to 1 hour). The authors also noted that there is great debate about the most optimal DBS parameters and that setting configurations should be made based on each patient and each disease. Additionally, they noted that when other electrically based tests need to be performed, physicians should consider various setting configurations for the best possible results and minimization of patient discomfort.
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Lancet Neurology
Chaudhuri, KR, Healy DG, Schapira AH; & National Institute for Clinical Excellence (2006). Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurology, Mar; 5(3):235-45Mar; 5(3):235-45
This was a great article that reviewed the nonmotor symptoms of PD (depression, psychosis, falls, and sleep disturbances), which the authors discuss is significantly related to quality of life in patients with PD. They discuss that the research in PD lacks specific studies to look at nonmotor symptoms and subsequent treatment within the community. The authors noted that the cause of the nonmotor difficulties is relatively unknown. However, there are many hypotheses as to the causes and they specifically listed a 6 stage speculation by Braak and colleagues that indicated Nonmotor symptoms may occur prior to the later stage motor dysfunction: 1. Loss of smell due to the loss of dopamine in the brain/smell areas 2. Disruption of systems in the brain meant to maintain the homeostasis (balance or maintenance of order in one's body to function well) of the individual such as sleep disruption, sweating, inability to control temperature 3. and 4. (combined) Tremor and motor symptoms 5. and 6. (combined) Lewy body (abnormal grouping of protein in a cell that causes various diseases) involvement causing psychosis and hallucinations
The authors then went through commonly seen sleep disturbances (nocturnal non-motor symptoms, REM sleep behavior disorder, excessive daytime sleepiness), neuropsychiatric symptoms (depression, anxiety and apathy, psychosis and visual hallucinations, and cognitive impairments), and dysautonomia (dysfunction of the system in the body that controls automatic functions, for example constipation, sexual dysfunction, and pain). After discussing what the nonmotor symptoms are they then went on to discuss recognition of nonmotor symptoms by patients, carers, and treating physicians. They went through multiple measures of nonmotor symptoms as well as common treatments. They concluded with suggesting that nonmotor symptoms need to be identified early in the disease process to address the quality of life for the patient as well as his/her family and carers.
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