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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.

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.

Is deep brain stimulation safe for humans?

Deep brain stimulation (DBS) can have complications, with overall rates exceeding 25%, and permanent neurological issues occurring in 4-6% of cases. Common problems include infections, lead migrations, and device malfunctions, with some cases requiring additional surgery. ^{1 2 3 4 5}

How does the Percept RC treatment differ from other treatments for Parkinson's disease?

The Percept RC treatment is unique because it is a deep brain stimulation (DBS) device with sensing capabilities that can adapt its stimulation in real-time based on the patient's brain activity. This adaptive feature allows it to optimize treatment by responding to fluctuations in the patient's condition, potentially improving effectiveness and reducing side effects compared to traditional DBS. ^{6 7 8 9 10}

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

Research shows that the Percept RC device, which uses adaptive deep brain stimulation (aDBS), can improve motor function in Parkinson's patients by adjusting stimulation in real-time based on brain activity. This method has been shown to enhance clinical scores and reduce power consumption compared to traditional DBS. ^{6 8 10 11 12}

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.

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

Signed informed consent

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

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

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. [2021]

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

Controlling Parkinson's disease with adaptive deep brain stimulation. [2022]

5. England 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. [2022]

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

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. [2012]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

11. England pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Towards adaptive deep brain stimulation: clinical and technical notes on a novel commercial device for chronic brain sensing. [2021]