Trial Summary
What is the purpose of this trial?Background:
- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).
Objective:
- To provide DBS treatment to people with some movement disorders.
Eligibility:
- Adults 18 years and older with PD, ET, or certain forms of dystonia.
Design:
* Participants will be screened with medical history and physical exam. They will have blood and urine tests and:
* MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected.
* Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity.
* Chest X-ray.
* Tests of memory, attention, concentration, thinking, and movement.
* Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol.
* Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator.
* Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory.
Is Deep Brain Stimulation a promising treatment for movement disorders?Yes, Deep Brain Stimulation (DBS) is a promising treatment for movement disorders. It has been shown to be effective in treating conditions like Parkinson's disease, essential tremor, and dystonia. DBS works by sending electrical signals to specific areas of the brain, which can help control symptoms. It is a well-established and safe therapy that has improved the quality of life for many patients.1391011
What safety data is available for Deep Brain Stimulation?Deep Brain Stimulation (DBS) is generally well-tolerated but has some associated risks. Common complications include infections (2-16.2%), hemorrhages (1-6.3%), seizures (1-3%), and lead migrations (8.6%). Rare complications like intracerebral abscesses have also been reported. Device-related issues such as circuit impedance and device failure occur in a smaller percentage of cases. Over a third of adverse events may require surgical intervention for device explant or revision. Further research is needed to reduce these risks.2781213
What data supports the idea that Deep Brain Stimulation for Movement Disorders is an effective treatment?The available research shows that Deep Brain Stimulation (DBS) is highly effective for treating movement disorders like essential tremor, Parkinson's disease, and dystonia. For essential tremor, studies indicate a 50% reduction in tremor severity over 1 to 5 years. In dystonia patients, motor symptoms improve by 50% to 80% over 2 to 3 years. DBS has also become a preferred option over other surgeries like thalamotomy for essential tremor, providing significant relief. It improves motor symptoms, functional status, and quality of life in patients with advanced Parkinson's disease. Serious side effects are rare, making DBS a safe and effective treatment choice for these conditions.145611
Do I need to stop my current medications for this trial?The protocol does not specify if you need to stop your current medications. However, it mentions that participants should have an unsatisfactory clinical response to maximal medical management, which suggests that you may need to continue your current medications to evaluate their effectiveness before considering DBS.
Eligibility Criteria
This trial is for adults over 18 with Parkinson's Disease (PD), essential tremor (ET), or certain dystonias who've had a good response to dopaminergic meds for PD. It's not suitable for those with significant medical risks, secondary movement disorders, dementia, pregnancy, psychiatric issues, or an inability to undergo MRI scans.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with Parkinson's, primary dystonia, or essential tremor.
Exclusion Criteria
I have unusual or secondary movement disorders like shaking or stiffness.
Treatment Details
The study tests Deep Brain Stimulation (DBS) therapy in managing movement disorders. Participants will have DBS surgery followed by regular check-ups where the neurostimulator settings are adjusted based on their condition and responses assessed through various physical and cognitive tests.
1Treatment groups
Experimental Treatment
Group I: Single-armExperimental Treatment1 Intervention
Therapy
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
🇨🇦 Approved in Canada as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a clinic near you
Research locations nearbySelect from list below to view details:
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, MD
National Institutes of Health Clinical CenterBethesda, MD
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
References
Advances in neurostimulation for movement disorders. [2019]In just 12 years since its introduction, deep brain stimulation (DBS) has become well established as a safe and effective therapy in the treatment of medically refractory movement disorders. Ventralis intermedius (Vim) DBS has virtually replaced thalamotomy in the routine clinical treatment of essential tremor, affording relief to thousands of patients who previously would not have undergone surgery, and there is increasing usage of Vim DBS in other tremors of intention (e.g., multiple sclerosis). Subthalamic nucleus (STN) and globus pallidus internus (GPi) DBS have revolutionized the treatment of advanced stage Parkinson's disease, improving all cardinal disease features and increasing 'on' time without dyskinesias. Finally, DBS of various sub-cortical structures is being developed and tested in other less prevalent movement disorders such as dystonia. Future developments in this rapidly advancing area will no doubt include widening indications for this relatively safe surgical procedure, elucidation of the mechanisms of action of electrical stimulation, and technological advancements improving effectiveness and convenience.
Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]Deep brain stimulation (DBS) is a surgical technique used to alleviate symptoms in patients with advanced Parkinson's disease (PD). It is a reversible procedure and its effect is based on electrical modulation of the nervous system and has considerable advantages in morbidity-mortality when compared to lesion techniques such as thalamotomy and/or pallidotomy. The objective was to evaluate the adverse events during the surgical placement of leads in the subthalamic nucleus for the treatment of Parkinson's disease.
[Deep brain stimulation in the treatment of movement disorders]. [2008]The introduction of deep brain stimulation (DBS) was a historical step forward for the treatment of advanced and medically intractable movement disorders that include Parkinson's disease, dystonias, essential tremor, and Holmes' tremor. DBS is able to modulate the target region electrically in a reversible and adjustable fashion in contrast to an irreversible and destructive lesioning procedure. In the treatment of movement disorders, the potential targets are the thalamic ventral intermediate nucleus (Vim), globus pallidus internus (GPi), subthalamic nucleus (STN), pedunculopontine nucleus (PPN), and thalamic Vo-complex nucleus. With the development of DBS technology and stereotactic neurosurgical techniques, its therapeutic efficacy has been increased while reducing surgical complications. DBS has become an established therapy for disabling movement disorders and is currently being used to treat neuropsychiatric disorders.
Hardware complications in deep brain stimulation: electrode impedance and loss of clinical benefit. [2012]Deep brain stimulation (DBS) is an effective treatment in patients with movement disorders. Successful outcomes are correlated with patient selection, accurate placement of the electrodes in their surgical target and optimal programming of patients. The loss of clinical efficacy after successful treatment may be related to hardware complications.
Surgical considerations for tremor and dystonia. [2012]Deep brain stimulation (DBS) is among the most effective approaches for the treatment of patients with advanced movement disorders. In patients with essential tremor, stimulation typically targets the ventral intermediate nucleus of the thalamus. Results of several studies have shown that over a follow-up period of 1 to 5 years, the severity of tremor decreases by an average of approximately 50% from baseline. Ongoing research continues to define the optimal stimulation parameters for patients with tremor, including frequency, voltage, and pulse width. In patients with dystonia, DBS typically targets the globus pallidus internus or the subthalamic nucleus. Long-term prospective clinical trials demonstrated reductions in motor severity rating scale scores of approximately 50% to 80% over follow-up periods of 2 to 3 years. Serious adverse events were uncommon, and included lead failures and infections. Appropriate candidates for DBS treatment of dystonia include patients with an unequivocal diagnosis of dystonia and significant disability. Several issues in the use of DBS for movement disorders remain unresolved, including the intensity of appropriate medical management before undergoing DBS, the importance of intraoperative mapping, optimal stimulator programming, and the time course of the beneficial effects of treatment.
Movement disorders and neuromodulation. [2022]Movement disorders are neurological conditions affecting speed, fluency, quality, and ease of movement. Deep brain stimulation (DBS) is used to treat advanced Parkinson's disease, essential tremor, and dystonia. Possible target sites for DBS include the ventral intermediate nucleus of the thalamus, the globus pallidus internus, and the subthalamic nucleus. High-frequency DBS leads to a kind of functional deafferentation of the stimulated structure and to the modulation of cortical activity. This has a profound effect on the efficiency of movement. Indications for the use of DBS include the need to improve function, reduce medication dependency, and avoid ablative neurosurgery. Appropriate patient selection is critical for success. The implantation technique is briefly described. Programming stimulation parameters are performed via telemetry. The adverse effects of DBS are discussed. The future should see the development of "closed-loop" systems. Its use has promoted interdisciplinary team work and provided an improved understanding of the complex neurocircuitry associated with these disorders. DBS is a highly effective, safe, and reversible surgical treatment for advanced Parkinson's disease, tremor, and dystonia. It is a useful therapeutic option in carefully selected patients that significantly improves motor symptoms, functional status, and quality of life.
Intracerebral abscess: a rare complication of Deep Brain Stimulation. [2013]Deep Brain Stimulation (DBS) is a therapeutic option for some forms of Parkinson's disease (PD). The main adverse effects of this surgery are: infection (2-9%), haemorrhage (1-4%) and seizures (1-3%). We report a rare complication of DBS: an intracranial abscess.
Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. [2018]Deep brain stimulation (DBS) has been shown to be effective for parkinsonian symptoms poorly responsive to medications. DBS is typically well-tolerated, as are the maintenance battery changes. Here we describe an adverse event during a battery replacement procedure that caused rapid onset of severe depression.
Radiofrequency Lesions through Deep Brain Stimulation Electrodes in Movement Disorders: Case Report and Review of the Literature. [2018]Although there are few reports of radiofrequency lesions performed through deep brain stimulation (DBS) electrodes in patients with movement disorders, experience with this method is scarce.
[Deep brain stimulation in movement disorders: evidence and therapy standards]. [2018]The deep brain stimulation (DBS) in movement disorders is well established and in many aspects evidence-based procedure. The treatment indications are very heterogeneous and very specific in their course and therapy. The deep brain stimulation plays very important, but usually not the central role in this conditions. The success in the application of DBS is essentially associated with the correct, appropriate and timely indication of the therapy in the course of these diseases. Thanks to the good standardization of the DBS procedure and sufficient published data, the recommendations for indication, diagnosis and operative procedures can be generated. The following article attempts to summarize the most important decision-making criteria and current therapy standards in this fairly comprehensive subject and to present them in close proximity to practice.
Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. [2022]Deep brain stimulation (DBS) is an effective treatment for movement disorders and neurological/psychiatric disorders. DBS has been approved for the control of Parkinson disease (PD) and epilepsy.
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]Introduction Deep brain stimulation (DBS) is a modality of treatment for medication refractory Parkinson's disease (PD) in patients with debilitating motor symptoms. While potentially life-changing for individuals with Parkinson's disease, characterization of adverse events for these DBS devices have not yet been systematically organized. Therefore, the goal of this study was to characterize reported complications of DBS devices reported to the Food & Drug Administration over the last 10 years. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was utilized to retrieve entries reported under "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms" between July 31, 2010 and August 1, 2020. After removing duplicate entries, each unique adverse event reported was sorted into complication categories based on the entries' provided narrative description. A final tabulation of complications was generated. Results The search query revealed 221 unique adverse events. The most common DBS devices were the Vercise Gevia, Vercise Cartesia and Vercise PC produced by Boston Scientific (Brian Walker, Boston Scientific, Marlborough, MA, USA). The most commonly reported complications were infection (16.2%) follow by lead migrations (8.6%). Other common causes of complications were circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%) and device-related trauma (4.5%). Over a third (40%) of all devices reported with adverse events required returning to the operating room for explant or revision. Conclusion The most common complications of DBS systems are infections followed by lead migrations. Further research is needed to minimize infection rates associated with DBS systems and to reduce intrinsic device malfunctions for patients in the future.
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]The number of deep brain stimulation (DBS) procedures is rapidly rising as well as the novel indications. Reporting adverse events related to surgery and to the hardware used is essential to define the risk-to-benefit ratio and develop novel strategies to improve it.