Deep Brain Stimulation for Parkinson's Disease

Overseen By Doris D Wang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Doris Wang, MD, PhD

Must not be taking: Anticoagulants

Disqualifiers: Uncontrolled hypertension, Heart disease, Seizures, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adaptive deep brain stimulation (DBS) can reduce or stop freezing of gait in people with Parkinson's disease. Participants will receive the Percept RC device, a type of deep brain stimulation device designed to adjust stimulation based on movement patterns. The trial tests three different treatment approaches, including increased and decreased stimulation, as well as a standard DBS method. It is suitable for individuals with Parkinson's who have experienced motor symptoms for over three years and have not found relief from medication alone. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that may lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have tried oral medications without adequate relief, so it's possible you may continue them unless advised otherwise by the study team.

What prior data suggests that this device is safe for use in Parkinson's disease patients?

Research has shown that both adaptive deep brain stimulation (aDBS) and open-loop deep brain stimulation (DBS) are generally safe for people with Parkinson's disease. Studies have found that long-term use of aDBS is well-tolerated, effective, and safe for patients with stable symptoms. Patients have reported improved well-being and easier movement without serious side effects.

For open-loop DBS, evidence confirms its safety in treating Parkinson's disease and other conditions like essential tremor and dystonia. The FDA has approved the Medtronic Percept RC device for these uses, indicating it meets safety standards. Overall, both treatments have promising safety records based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Deep Brain Stimulation (DBS) treatments for Parkinson's disease because they offer a more personalized approach compared to standard DBS treatments. Unlike traditional DBS, which provides continuous stimulation, the adaptive DBS under investigation can adjust the level of stimulation in response to specific gait-behavior biomarkers. This means the Percept RC device can increase or decrease stimulation based on the patient's needs at any given moment, potentially leading to better symptom management and fewer side effects. This innovative, real-time response could significantly enhance the quality of life for those with Parkinson's, making it a promising advancement in the treatment of this condition.

What evidence suggests that adaptive deep brain stimulation is effective for freezing of gait in Parkinson's disease?

Research has shown that deep brain stimulation (DBS) effectively treats Parkinson's disease, particularly for movement issues. In this trial, participants will join different treatment arms to evaluate various DBS approaches. Studies suggest that adaptive DBS, which adjusts stimulation based on a person's movements, might outperform traditional DBS. This method could be especially beneficial for addressing freezing of gait, a common problem in Parkinson's patients. The Percept RC system used in adaptive DBS has shown promise in improving movement symptoms. One trial arm will involve adaptive DBS with ramp-up stimulation, while another will involve ramp-down stimulation. Meanwhile, open-loop DBS, which provides constant stimulation, is a well-known treatment for Parkinson's and will be evaluated in a separate arm, though it does not adjust to movement changes like the adaptive version. ^{1 6 7 8 9}

Who Is on the Research Team?

Doris D Wang, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people aged 21-75 with Parkinson's Disease who experience severe movement issues despite medication, including freezing of gait. They must be able to recharge the DBS system, have no MR abnormalities that contraindicate surgery, and score at least 21 on the MoCA test indicating no significant cognitive impairment.

Inclusion Criteria

I have chosen to undergo deep brain stimulation surgery for my condition.

Signed informed consent

My movement disorder is severe enough to need surgery despite medication.

Exclusion Criteria

Significant untreated depression (BDI-II score >20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)

Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure

Any personality or mood symptoms that study personnel believe will interfere with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo DBS insertion surgery and placement of permanent sensors

1 week

Treatment

Participants receive adaptive DBS settings and are monitored using at-home devices

2 years

Regular lab visits for check-ins and testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Percept RC

Trial Overview

The study tests if adaptive deep brain stimulation (DBS) can help reduce or prevent freezing of gait in Parkinson's patients. Participants will receive surgical implantation of a device called Percept RC and attend follow-up visits for brain recording and assessment.

How Is the Trial Designed?

Group I: Adaptive deep brain stimulation (ramp-up) Active Control 1 Intervention

Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving increased stimulation in-response to gait-behavior biomarker.

Group II: Adaptive deep brain stimulation (ramp-down) Active Control 1 Intervention

Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving decreased stimulation in-response to gait-behavior biomarker.

Group III: Open-loop deep brain stimulation Active Control 1 Intervention

Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.

Who Is Running the Clinical Trial?

Doris Wang, MD, PhD

Lead Sponsor

Trials

2

Recruited

30+

Published Research Related to This Trial

The Medtronic 'Percept' device, the first FDA-approved deep brain stimulation system with sensing capabilities, was tested on 7 subjects to identify and mitigate artifacts in local field potential signals that could affect its performance.

Using automated template subtraction techniques, researchers successfully removed various artifacts, such as ECG signals and nonphysiologic noise, which could otherwise distort the neural signals and impact the effectiveness of adaptive deep brain stimulation algorithms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. Hammer, LH., Kochanski, RB., Starr, PA., et al.[2023]

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) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

Adaptive deep brain stimulation (aDBS) shows promise in improving Parkinson's disease treatment by adjusting stimulation in real-time based on the patient's brain activity, specifically targeting beta amplitude fluctuations.

In early trials, aDBS demonstrated reduced power consumption and improved motor function scores compared to traditional deep brain stimulation, suggesting it could be a more efficient and effective long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling Parkinson's disease with adaptive deep brain stimulation. Little, S., Pogosyan, A., Neal, S., et al.[2022]

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) can improve motor function and quality of life in patients with Parkinson's disease when used alongside traditional medication, particularly for those whose symptoms are not well-controlled by medication alone.

However, while DBS offers significant benefits, it also comes with a higher risk of adverse events compared to pharmacotherapy, highlighting the need to carefully consider the risks and benefits before opting for this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. Sharma, A., Szeto, K., Desilets, AR.[2012]

A 51-year-old man with Parkinson's disease experienced successful motor fluctuation management using an adaptive deep brain stimulation (aDBS) device, which adjusts stimulation based on real-time neural activity.

The aDBS device effectively adapted to changes in beta oscillations without causing side effects, suggesting it is a feasible and innovative approach to enhance treatment for Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. Nakajima, A., Shimo, Y., Fuse, A., et al.[2021]

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 important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

The study involving 53 patients with Parkinson's disease showed that a new multiple-source, constant-current deep brain stimulation (DBS) system significantly improved motor symptoms, with a mean reduction of 23.8 points in the UPDRS III score after 6 months.

The safety profile of the DBS system was acceptable, with only 18 serious adverse events reported, all of which resolved without lasting effects, indicating that the device is a promising option for managing Parkinson's motor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Timmermann, L., Jain, R., Chen, L., et al.[2022]

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