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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how deep brain stimulation (DBS) can help people with Parkinson's disease and dystonia improve their movement symptoms. Researchers are using a new device, Summit RC+S, which monitors brain activity and delivers targeted stimulation to manage symptoms more effectively. Participants will have either Parkinson's disease with severe movement issues not fully controlled by medication or isolated dystonia that significantly disrupts daily life. The study tests DBS in different brain areas to determine the most effective sites. The goal is to develop a more effective treatment for those struggling with these conditions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to improved treatments for movement disorders.

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 prior data suggests that this neural interface is safe for Parkinson's disease and dystonia patients?

Research shows that deep brain stimulation (DBS) is a safe treatment for Parkinson's disease. Studies have found that DBS works better than standard medication for people with moderate-to-severe Parkinson’s disease. The treatment often uses a device called Medtronic Summit RC+S, which tracks brain activity and provides stimulation.

Early results from clinical trials with the Summit RC+S device suggest that patients handle it well, with no major safety issues reported. Experts agree that automatic DBS programming, which adjusts the stimulation level, remains safe within certain limits. This allows the device to adapt to the patient's needs without risk.

Overall, while DBS is a more advanced treatment, it has a strong safety record in clinical trials. For those considering joining a trial, it is reassuring that past studies have found DBS to be both effective and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of Deep Brain Stimulation (DBS) using the Summit RC+S device for Parkinson's disease because it represents an advanced approach to managing symptoms. Unlike traditional treatments like medication or earlier DBS systems, the Summit RC+S device offers real-time brain activity monitoring, allowing for more precise and personalized adjustments to the stimulation. This could lead to improved symptom control and potentially fewer side effects. Additionally, targeting specific brain areas such as the Globus Pallidus and Subthalamic Nucleus (STN) with this technology could enhance its effectiveness for different patient needs.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease and dystonia?

Research has shown that deep brain stimulation (DBS) can significantly reduce both movement and non-movement symptoms in people with Parkinson's disease (PD) by 60–80%. This treatment has also been linked to a long-term decrease in medication use by 44%. In this trial, the Summit RC+S device is used for DBS, and it has helped patients reduce their need for levodopa (a common PD medication) by more than 80%. The trial will compare closed-loop (adaptive) DBS, which adjusts stimulation based on brain activity, with regular DBS. Studies have found that closed-loop DBS is as effective as regular DBS in reducing PD symptoms. This treatment can offer significant improvements for those with Parkinson's disease and possibly for patients with dystonia. ^{1 2 3 6 7}

Who Is on the Research Team?

Philip Starr, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

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

Dystonia: Ability to give informed consent for the study

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357172/

Closed-Loop Adaptive Deep Brain Stimulation in ... Concerning PD, multiple clinical studies have demonstrated that DBS was more effective than best medical therapy for moderate-to-severe PD [9] ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923001526

On-Off and Proportional Closed-Loop Adaptive Deep Brain ... Adaptive DBS, using both on-off and proportional control schemes, is as effective as conventional DBS in reducing motor symptoms of PD in parkinsonian rats.

3. tandfonline.com tandfonline.com/doi/full/10.2147/JPRLS.S306244

Full article: Deep Brain Stimulation in Parkinson's Disease DBS has the potential to reduce motor and non-motor PD symptoms by 60–80%, with sustained reduction in medication use by 44% after 8 to 15 years ...

4. nature.com nature.com/articles/s41531-025-00974-5

Will adaptive deep brain stimulation for Parkinson's ... In the next 10 years, aDBS will be clinical routine, but research is needed to define which patients would benefit more from the treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04675398

Adaptive Deep Brain Stimulation to Improve Motor and Gait ... This is a single-center phase I clinical study aiming to improve gait functions in patients with Parkinson's disease (PD) by using adaptive neurostimulation ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06012461

NCT06012461 | Closed-loop DBS in Parkinson's Disease The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9614806/

Automated deep brain stimulation programming with safety ... In this study, we describe and evaluate an automated, closed-loop, and patient-specific framework for DBS programming that measures tremor using ...