Deep Brain Stimulation for Movement Disorders

Recruiting at 1 trial location

Overseen By Sharon C Park

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Under 18, Unable to consent, 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: 6

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of deep brain stimulation (DBS) for individuals with movement disorders such as Parkinson's disease, dystonia, and essential tremor. DBS involves placing a device under the skin to send electrical signals to the brain, which can help reduce abnormal movements. Researchers aim to assess how well DBS improves movement and to gather information on brain function during the procedure. Individuals with Parkinson's, dystonia, or essential tremor that medication has not significantly helped might be suitable for this trial. Participants will undergo surgery and be monitored over several months to observe changes in their movement and quality of life. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could enhance treatment options for movement disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

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

Research has shown that deep brain stimulation (DBS) is a safe and effective treatment for movement disorders that don't respond well to medication. Studies have found that DBS can greatly improve symptoms like shaking, stiffness, and slow movement in people with Parkinson's disease and other conditions.

The FDA has approved DBS for these uses, confirming its safety. The procedure involves placing a small device under the skin that sends electrical signals to the brain. These signals help block the nerve messages that cause unwanted movements. Many who have undergone DBS report better movement control, and these improvements can last for many years.

Overall, most patients tolerate DBS well. While some might experience side effects, these are usually manageable and can be adjusted by fine-tuning the device. This makes DBS a promising option for those dealing with certain movement disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Deep Brain Stimulation (DBS) is unique because it offers a surgical approach to managing movement disorders like Parkinson's Disease, dystonia, and essential tremor, which are typically treated with medications such as levodopa or dopamine agonists. Unlike these standard drugs that work by altering brain chemistry, DBS involves implanting electrodes in the brain to deliver electrical impulses, directly modulating abnormal brain activity. This can provide more precise symptom control and often with fewer side effects than medications. Researchers are excited about DBS because it has the potential to significantly improve quality of life for patients who do not respond well to other treatments.

What is the effectiveness track record for Deep Brain Stimulation in treating movement disorders?

Research has shown that deep brain stimulation (DBS), which participants in this trial will receive, helps with movement disorders like Parkinson's disease, essential tremor, and dystonia. For people with Parkinson's, DBS can ease symptoms such as shaking, stiffness, and slow movement. Studies have found it can control shaking in essential tremor for at least six years. Although DBS doesn't stop Parkinson's from worsening, it provides lasting benefits when used in the middle stages of the disease. For dystonia, DBS can help lessen unwanted muscle movements. Overall, DBS acts like a pacemaker for the brain, stopping signals that cause unusual movements. ^{2 3 4 6 7}

Who Is on the Research Team?

Kareem A Zaghloul, 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 movement disorders like Parkinson's disease, essential tremor, and dystonia that aren't well-managed by medication. Candidates must be able to understand and agree to the study's procedures.

Inclusion Criteria

My Parkinson's disease, primary dystonia, or essential tremor is not well-controlled by medication.

Able to provide informed consent.

Exclusion Criteria

Are unable or unwilling to give informed consent to the research procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery

Deep brain stimulation surgery is performed, and intra-operative recordings are taken to study brain function.

1 day

1 visit (in-person)

Post-Surgery Recovery

Participants recover in the hospital and have a follow-up visit within 4 weeks to turn on and adjust the stimulator.

4 weeks

1 visit (in-person)

Follow-up

Participants return for follow-up visits at 1, 2, and 3 months after surgery to test movement, memory, and quality of life.

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview The trial studies Deep Brain Stimulation (DBS) surgery effects on movement disorders. It involves implanting a device to stimulate brain areas linked to movement and recording nerve cell function during surgery.

How Is the Trial Designed?

Group I: treatment arm Experimental Treatment 2 Interventions

patients with Parkinson's Disease, dysonia, and essential tremor

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) 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]

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]

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]

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) 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]

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 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]

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 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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3382386/

Deep Brain Stimulation for Parkinson's Disease and Other ... There is Level 3a evidence that DBS of the thalamus is effective in the control of tremor in patients with essential tremor and PD for at least 6 years. There ...

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

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

3. 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 ... “DBS used to be seen as a last resort, but we now know it provides the most sustained benefit when offered in the moderate stages of Parkinson's ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

Five-Year Outcomes from Deep Brain Stimulation of the ... This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.

5. nature.com nature.com/articles/s41467-024-48731-1

Deep brain stimulation of symptom-specific networks in ... Deep Brain Stimulation can improve tremor, bradykinesia, rigidity, and axial symptoms in patients with Parkinson's disease.

6. 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-approved ...

7. mayoclinic.org mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562

Deep brain stimulation Deep brain stimulation is an established treatment for people with movement conditions. These conditions include essential tremor, Parkinson's ...