Deep Brain Stimulation for Parkinson's Disease

Overseen By Robert Wilt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiparkinsonian, Anti-dystonia

Must not be taking: Anticoagulants

Disqualifiers: Coagulopathy, Uncontrolled hypertension, Seizures, Heart disease, others

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of their current medications for at least 30 days before starting the study. This means you should not change your medication regimen before the trial, but the protocol does not specify if you need to stop taking them during the trial.

What data supports the effectiveness of this treatment for Parkinson's Disease?

Research shows that deep brain stimulation (DBS) significantly improves motor symptoms and daily activities in patients with advanced Parkinson's disease, reducing tremors, rigidity, and medication side effects. DBS is also effective in improving quality of life and social functioning in patients with early motor complications. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) can have complications, with common issues including infections and device malfunctions. Overall, complication rates can exceed 25%, and serious long-term effects occur in 4-6% of cases. It's important to understand these risks when considering DBS. ^{6 7 8 9 10}

How is the Summit RC+S treatment for Parkinson's disease different from other treatments?

The Summit RC+S treatment involves deep brain stimulation (DBS), which is a surgical procedure that uses electrical impulses to regulate brain activity, offering an option for patients with advanced Parkinson's disease who do not respond well to medication. This treatment is unique because it targets specific brain areas to improve motor symptoms and quality of life, unlike traditional drug therapies. ^{2 4 11 12 13}

What is the purpose of this trial?

This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S. This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.

Research Team

Philip Starr, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults aged 21-75 with Parkinson's Disease or Dystonia who need surgical intervention despite medication. Participants must be able to consent, follow the study schedule, and have no significant cognitive impairment (MoCA score ≥20). Exclusions include drug/alcohol abuse, certain cognitive impairments in PD patients, psychogenic movement disorders, pregnancy, implanted devices like pacemakers or neurostimulators, coagulopathy or other surgery risks.

Inclusion Criteria

I can attend all required study visits for my dystonia treatment.

Dystonia: Ability to give informed consent for the study

Parkinson's Disease: Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment

Exclusion Criteria

You have an implanted device like a pacemaker or neurostimulator.

Parkinson's Disease: Any personality or mood symptoms that study personnel believe will interfere with study requirements

I am not pregnant or have tested negative for pregnancy before my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Testing

Participants are implanted with the RC+S device and undergo initial testing of stimulation algorithms

2 weeks

Multiple visits for implantation and initial testing

Closed-loop Stimulation Trial

Participants undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days

4 weeks

Regular monitoring visits

Chronic Adaptive DBS Testing

Participants test chronic and fully closed-loop DBS at home, with data collection on stimulation effects

Up to 4 years

Periodic follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 8-week pilot trial of Closed-loop vs. Open-loop Stimulation
• Summit RC+S

Trial Overview The study tests a neural interface device called Medtronic Summit RC+S in people with Parkinson's Disease and Dystonia. It explores how brain activity relates to motor symptoms by comparing closed-loop stimulation (automatic adjustment) versus open-loop stimulation (constant level) over an eight-week period.

Participant Groups

Group I: Parkinson's disease patients GP Target Experimental Treatment 3 Interventions

Parkinson's disease patients implanted in Globus Pallidus

Group II: Parkinson's Disease STN Target Experimental Treatment 3 Interventions

Parkinson's disease patients implanted in STN

Group III: Dystonia patients Experimental Treatment 2 Interventions

Isolated dystonia patients

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Findings from Research

In a study of 20 patients with advanced Parkinson's disease, deep brain stimulation (DBS) of the subthalamic nucleus (STN) led to significant improvements in motor symptoms, with a 49.3% reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) scores in the 'off' medication state after one year.

DBS also enhanced daily living activities by 73.8%, reduced the need for medication by 54.1%, and decreased complications like dyskinesia and motor fluctuations, indicating its efficacy in managing Parkinson's disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Advanced Parkinson's Disease Manifestations with Deep Brain Stimulation of the Subthalamic Nucleus: A Single Institution Experience. Rabie, A., Verhagen Metman, L., Fakhry, M., et al.[2020]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

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]

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]

In a study of 26 elderly patients with Parkinson's disease undergoing subthalamic deep brain stimulation (STN-DBS), there was a higher incidence of serious adverse events, particularly psychosis and hallucinations, compared to younger patients from the EARLYSTIM study.

Despite these psychiatric complications being transient, the overall benefits of STN-DBS in improving Parkinson's symptoms were found to outweigh the risks, highlighting the importance of thorough psychiatric evaluations before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. Cozac, VV., Ehrensperger, MM., Gschwandtner, U., et al.[2020]

In a study of 69 patients with advanced Parkinson's disease who underwent deep brain stimulation (DBS), 53% of those with subthalamic nucleus (STN) stimulation reported ongoing adverse events (AEs) four years post-surgery, compared to 35% in the internal globus pallidus (GPi) group.

Most AEs were not severe and affected cognitive, psychiatric, and motor functions, with a notable correlation between the presence of AEs and longer disease duration and pre-existing gait and psychiatric issues in STN DBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. Hariz, MI., Rehncrona, S., Quinn, NP., et al.[2008]

Deep brain stimulation (DBS) for advanced Parkinson's disease, using Multiple Sequences Image Fusion (MuSIF) for accurate targeting, led to a significant reduction of 76% in L-dopa equivalent daily dose after 3 months.

Patients experienced a 50% reduction in dyskinesias and a 45% decrease in motor fluctuations, demonstrating the efficacy of the combined imaging techniques in improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation. Rampini, PM., Locatelli, M., Alimehmeti, R., et al.[2017]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement of Advanced Parkinson's Disease Manifestations with Deep Brain Stimulation of the Subthalamic Nucleus: A Single Institution Experience. [2020]

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

Deep Brain Stimulation Impact on Social and Occupational Functioning in Parkinson's Disease with Early Motor Complications. [2022]

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

Deep brain stimulation may reduce the relative risk of clinically important worsening in early stage Parkinson's disease. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation for Parkinson's disease]. [2021]

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

Insights gleaned by measuring patients' stated goals for DBS: More than tremor. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. [2007]

7. Austria pubmed.ncbi.nlm.nih.gov

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

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. Switzerland pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. [2020]

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

Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. [2008]

11. Italy pubmed.ncbi.nlm.nih.gov

Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation. [2017]

12. Italy pubmed.ncbi.nlm.nih.gov

Subthalamic nucleus stimulation in Parkinson's disease. [2021]

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

Comparison of subthalamic nucleus deep brain stimulation and Duodopa in the treatment of advanced Parkinson's disease. [2013]