Deep Brain Stimulation for Movement Disorders

Recruiting at 1 trial location

Overseen By Debra J Ehrlich, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Must be taking: Dopaminergic medication

Must not be taking: Neuroleptics

Disqualifiers: Uncontrolled hypertension, Dementia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore deep brain stimulation (DBS) for people with movement disorders such as Parkinson’s disease, essential tremor, and certain forms of dystonia. DBS involves implanting a device that sends electrical signals to brain areas controlling movement, potentially easing symptoms. The trial seeks participants with these conditions who find their current treatments insufficient for managing daily activities. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have an unsatisfactory response to their current medical management, which might imply some changes could be necessary. It's best to discuss your specific medications with the study doctors.

What prior data suggests that this device is safe for treating movement disorders?

Research has shown that deep brain stimulation (DBS) is generally safe for treating movement disorders such as Parkinson's disease, dystonia, and essential tremor. DBS is often used for patients whose symptoms do not improve with medication. Studies indicate that although DBS is safer than some other surgeries, it can still lead to complications, such as infection or bleeding, though serious issues are rare. Overall, DBS is well-tolerated, and most patients experience significant symptom improvement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Deep Brain Stimulation (DBS) is unique because it directly targets specific areas of the brain by delivering electrical impulses through implanted electrodes. Unlike traditional treatments for movement disorders, such as medications like levodopa or dopamine agonists, which work by altering brain chemistry, DBS modulates neural activity in real-time. This can lead to more immediate and potentially more effective symptom control, particularly for those who may not respond well to medication. Researchers are excited about DBS because it offers a more precise and adjustable way to manage symptoms, potentially improving quality of life for individuals with movement disorders.

What evidence suggests that deep brain stimulation is effective for movement disorders?

Studies have shown that deep brain stimulation (DBS) can improve symptoms of movement disorders such as Parkinson's disease, dystonia, and essential tremor. It reduces movement problems, disease severity, and shaking. DBS corrects unusual brain signals that cause these disorders. Research indicates that patients experience improved movement and may require less medication. Overall, DBS can enhance the quality of life for individuals with these conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Debra J Ehrlich, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Are You a Good Fit for This Trial?

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

Able to comply with study procedures and provide informed consent

I am considering or already have a deep brain stimulation device for my movement disorder.

I have been diagnosed with Parkinson's, primary dystonia, or essential tremor.

Exclusion Criteria

Dementia, cognitive impairments, or unstable psychiatric disorders

Inability to undergo MR-imaging or cognitive assessments

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Initial Programming

Eligible participants will have DBS surgery. Study doctors will see participants 3-4 weeks after surgery to turn on the neurostimulator.

4 weeks

1 visit (in-person)

Follow-up

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.

2 years

Multiple visits (in-person)

Long-term Follow-up

Participants have the option to transfer their care back to the neurologists in the community or continue care with the NIH Neurology team until care in the community is available.

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation
• Deep Brain Stimulation Management

Trial Overview 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.

How Is the Trial Designed?

Group I: Single-arm Experimental Treatment 1 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

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) is highly effective for treating advanced movement disorders, with essential tremor patients experiencing an average tremor reduction of about 50% over 1 to 5 years.

In patients with dystonia, DBS can lead to a significant decrease in motor severity scores by 50% to 80% over 2 to 3 years, with serious adverse events being rare, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical considerations for tremor and dystonia. Cooper, S., Bowes, M.[2012]

Deep brain stimulation (DBS) is a significant advancement in treating advanced movement disorders like Parkinson's disease and dystonias, offering a reversible and adjustable alternative to traditional lesioning procedures.

DBS targets specific brain regions, such as the subthalamic nucleus and globus pallidus internus, enhancing therapeutic efficacy while minimizing surgical complications, and is now also being explored for neuropsychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in the treatment of movement disorders]. Goto, S.[2008]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Deep brain stimulation (DBS) is a highly effective and safe surgical treatment for advanced Parkinson's disease, essential tremor, and dystonia, significantly improving motor symptoms and quality of life in carefully selected patients.

DBS works by modulating cortical activity and reducing the need for medication, making it a reversible option that promotes better movement efficiency and understanding of the underlying neurocircuitry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement disorders and neuromodulation. Shipton, EA.[2022]

Deep brain stimulation (DBS) is an effective treatment for movement disorders like Parkinson's disease and epilepsy, with ongoing advancements in both open-loop and closed-loop systems.

Recent research is increasingly focusing on closed-loop DBS systems, which may offer improved outcomes by adapting stimulation based on real-time feedback from the patient's brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. Wu, YC., Liao, YS., Yeh, WH., et al.[2022]

In a study of 110 patients with deep brain stimulation (DBS) for movement disorders, 6.3% experienced a loss of clinical efficacy, often linked to increased electrode impedance (>4000 Ω).

Most patients with loss of efficacy required reoperation for electrode replacement, highlighting the need for a protocol to identify hardware issues early in patients receiving DBS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hardware complications in deep brain stimulation: electrode impedance and loss of clinical benefit. Guridi, J., Rodriguez-Oroz, MC., Alegre, M., et al.[2012]

Deep brain stimulation (DBS) has proven to be a safe and effective treatment for movement disorders, particularly essential tremor and advanced Parkinson's disease, significantly improving patient outcomes.

Vim DBS has largely replaced thalamotomy for essential tremor, while STN and GPi DBS enhance 'on' time without dyskinesias in Parkinson's patients, indicating a shift towards more effective surgical options in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in neurostimulation for movement disorders. Gross, RE., Lozano, AM.[2019]

Radiofrequency lesions performed through deep brain stimulation (DBS) electrodes in two patients with movement disorders resulted in significant clinical improvements, with reductions in their Fahn-Tolosa-Marin Scale and Unified Parkinson's Disease Rating Scale scores over 20 and 8 months, respectively.

The procedure was safe, with no adverse effects reported, and allowed for better management of symptoms with lower current and medication requirements after treatment, suggesting it could be a valuable alternative in treating movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Lesions through Deep Brain Stimulation Electrodes in Movement Disorders: Case Report and Review of the Literature. Pérez-Suárez, J., Torres Díaz, CV., López Manzanares, L., et al.[2018]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

Deep brain stimulation (DBS) is effective for managing parkinsonian symptoms, but in rare cases, it can lead to severe mood disruptions, as demonstrated by a 58-year-old woman who developed rapid-onset depression during a routine battery replacement procedure after 5 years of DBS treatment.

Electroconvulsive therapy (ECT) proved to be an effective treatment for the patient's severe depression, highlighting its potential as a therapeutic option for patients experiencing intractable mood disorders related to DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. Cunningham, MG., Yadollahikhales, G., Vitaliano, G., et al.[2018]

Deep Brain Stimulation (DBS) for Parkinson's disease can lead to rare complications, such as an intracranial abscess, as demonstrated in a case involving a 59-year-old male who developed significant inflammation and required multiple surgeries after the procedure.

Despite the complications, the patient's Parkinson's symptoms improved after the abscess was surgically drained, suggesting that the abscess may have inadvertently provided some therapeutic benefit similar to a subthalomotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. Brandão, E., Rosas, MJ., Abreu, P., et al.[2013]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Deep brain stimulation (DBS) is an established and evidence-based treatment for various movement disorders, but its effectiveness largely depends on the correct and timely indication for therapy.

The article emphasizes the importance of standardized procedures and published data in guiding the decision-making process for DBS, ensuring that it is applied appropriately in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in movement disorders: evidence and therapy standards]. Parpaley, Y., Skodda, S.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30660117/

Long-term outcomes following deep brain stimulation for ... Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40212163/

Deep brain stimulation (DBS) in movement disorders ... Conclusion: DBS demonstrates efficacy in improving motor symptoms, disease severity, tremor, gait, and tic severity in movement disorders.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005767

Mechanisms of Deep Brain Stimulation in Movement ... Effective DBS overrides pathological bursts, low frequency oscillations, synchronization, and disrupted firing patterns present in movement disorders.

4. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02119611

Deep Brain Stimulation Therapy in Movement Disorders DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397644/

Deep brain stimulation: current challenges and future directions To date, few indications have been approved for DBS, with the vast majority of procedures performed for movement disorders, most commonly Parkinson disease (PD) ...

7. ninds.nih.gov ninds.nih.gov/health-information/disorders/deep-brain-stimulation-dbs

Deep Brain Stimulation (DBS) It is a safe and effective treatment for many movement disorders that are not responding to medication. More recently, DBS was also FDA ...

8. jns-journal.com jns-journal.com/article/S0022-510X(13)00820-4/fulltext

Safety issues of deep brain stimulation therapy for ... DBS commonly presents as quite safe compared to lesioning procedures. However, DBS could be related to different, even life-threatening, complications, limiting ...

9. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.70274

One Side or Two? A Systematic Review of Deep Brain ... The study revealed that bilateral STN stimulation improved the mean total UPDRS motor score by 53%, whereas unilateral stimulation improved ...