Deep Brain Stimulation for Movement Disorders

Recruiting at 1 trial location

Overseen by Kareem A Zaghloul, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Disqualifiers: Under 18, Unable to consent, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: - Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery. Objectives: * To study how DBS surgery affects Parkinson s disease, dystonia, and tremor. * To obtain information on brain and nerve cell function during DBS surgery. Eligibility: - People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia. Design: * Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests. * During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier. * After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings. * Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.

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 data supports the effectiveness of the treatment Deep Brain Stimulation for movement disorders?

Deep Brain Stimulation (DBS) is shown to be highly effective for movement disorders like Parkinson's disease, essential tremor, and dystonia, with studies indicating a 50% reduction in tremor severity and 50-80% improvement in motor symptoms over several years. It is considered safe and significantly improves quality of life in carefully selected patients. ^{1 2 3 4 5}

Is Deep Brain Stimulation generally safe for humans?

Deep Brain Stimulation (DBS) is generally well-tolerated, but it can have complications such as infections (2-16.2%), bleeding in the brain (1-6.3%), and seizures (1-3%). Some patients may need additional surgery to fix or remove the device if problems occur. ^{6 7 8 9 10}

How is deep brain stimulation different from other treatments for movement disorders?

Deep brain stimulation (DBS) is unique because it uses electrical impulses to modulate specific brain regions in a reversible and adjustable way, unlike other treatments that may involve permanent changes or medications. It has become a well-established option for advanced movement disorders like Parkinson's disease, offering an alternative to more invasive surgical procedures. ^{2 5 11 12 13}

Research Team

Kareem A Zaghloul, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria

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.

I am 18 years old or older.

Able to provide informed consent.

Exclusion Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Deep Brain Stimulation (Procedure)

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.

Participant Groups

Group I: treatment arm Experimental Treatment 2 Interventions

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

Deep Brain Stimulation is already approved in Canada for the following indications:

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+

Findings from Research

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 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) 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) 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]

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) 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 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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Surgical considerations for tremor and dystonia. [2012]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Hardware complications in deep brain stimulation: electrode impedance and loss of clinical benefit. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Movement disorders and neuromodulation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Advances in neurostimulation for movement disorders. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. [2013]

7. England 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. [2018]

8. United States 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. [2023]

9. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

10. Austria pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Radiofrequency Lesions through Deep Brain Stimulation Electrodes in Movement Disorders: Case Report and Review of the Literature. [2018]

12. Japan pubmed.ncbi.nlm.nih.gov

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

13. Germany pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in movement disorders: evidence and therapy standards]. [2018]