Closed Loop DBS for Parkinson's Disease

Overseen By Helen Bronte-Stewart, MD MSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Dementia, Untreated psychiatric disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of deep brain stimulation (DBS) for Parkinson's disease that adapts to a patient's changing needs. Unlike traditional DBS, which delivers constant electrical signals, this adaptive system adjusts its settings based on specific brain and movement signals to better manage symptoms like freezing of gait, tremors, and slow movements. The trial explores different approaches to determine which works best. Suitable participants have Parkinson's disease with issues like medication complications or symptoms affecting daily life and are willing to attend several study visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly improve symptom management for Parkinson's patients.

Do I need to stop my current medications for this trial?

The protocol does not specify if you need to stop your current medications. However, the trial is for those with complications from medication, so you might continue taking them.

What prior data suggests that this adaptive DBS device is safe for treating Parkinson's disease?

Research shows that adaptive deep brain stimulation (aDBS) is generally safe and well-tolerated for people with Parkinson's disease. Studies indicate that aDBS helps manage symptoms like tremors and slow movement by adjusting its signals based on patient needs. This personalized method has proven both effective and safe over time.

In earlier studies, patients using aDBS reported that it worked well and caused few side effects. While traditional deep brain stimulation (DBS) is already approved for Parkinson's, aDBS aims to be even more precise. DBS, being a minimally invasive procedure, has a strong safety record for treating various brain-related conditions.

Overall, aDBS is designed to improve standard treatment by adapting to the patient's condition, and current research suggests it achieves this safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Closed Loop Deep Brain Stimulation (DBS) for Parkinson's Disease because it represents a smarter way to manage symptoms. Unlike traditional DBS, which delivers constant stimulation, this adaptive or "closed loop" system adjusts its signals in response to the patient's brain activity or movements. This means the treatment can be more personalized and potentially more effective, reducing side effects and improving quality of life. Additionally, the use of devices like the Summit RC+S and Percept PC, which can respond to real-time changes, might offer a more dynamic and responsive approach to managing Parkinson's symptoms compared to the usual static treatment methods.

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

Research has shown that deep brain stimulation (DBS) is more effective than medication alone for treating moderate-to-severe Parkinson's disease symptoms. In this trial, participants will join different treatment arms involving various forms of DBS. Adaptive deep brain stimulation (aDBS), one of the approaches under study, adjusts to a patient's needs in real-time and has shown promise in overcoming the limits of traditional DBS. Studies have found that aDBS can improve movement, with one study noting a 43% improvement in motor skills compared to no stimulation. These improvements suggest that aDBS may be particularly effective for managing symptoms like tremors and difficulty walking, which are common in Parkinson's disease. This makes aDBS a promising option for those seeking more personalized treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Helen M Bronte-Stewart, MD MSE

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's Disease who experience gait issues despite medication. They must be eligible for or already have a specific deep brain stimulation device implanted and can attend follow-up visits. Exclusions include dementia, certain medical devices like pacemakers, severe health conditions, pregnancy, metal implants in the skull, seizures, and advanced-stage Parkinson's.

Inclusion Criteria

I am older than 18 years.

I experience freezing when I walk.

Your nerve response is above a certain level in a specific test.

Exclusion Criteria

You have a heart device called a pacemaker or defibrillator.

I don't have severe high blood pressure, bleeding disorders, or metabolic conditions that could complicate surgery.

I have a history of seizures or epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive DBS therapy, which responds to neural and kinematic features of the patient's current state, and intermittent open-loop DBS as a control

3 months

Regular visits every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of gait parameters and adverse events

6 months

Collected up to 10 days every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Bilateral Closed Loop Deep Brain Stimulation

Trial Overview

The study tests an adaptive Deep Brain Stimulation (DBS) system that adjusts its settings based on real-time feedback from the patient's neural activity and movement patterns. It aims to improve walking difficulties in Parkinson’s patients by customizing treatment to their immediate needs.

How Is the Trial Designed?

Group I: Device: Summit RC+S Experimental Treatment 3 Interventions

1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state 3. Intermittent Open Loop DBS: Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.

Group II: Device: Percept PC Experimental Treatment 2 Interventions

1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state

Bilateral Closed Loop Deep Brain Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Parkinson's disease
• Moderate to advanced levodopa-responsive Parkinson’s disease

Approved in European Union as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

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.

jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ...

Bilateral adaptive deep brain stimulation is effective in Parkinson's disease.  J Neurol Neurosurg Psychiatry. 2016;87(7):717-721. doi ...

3.

jnnp.bmj.com

jnnp.bmj.com/content/87/7/717

Bilateral adaptive deep brain stimulation is effective in ...

Results UPDRS scores were 43% (p=0.04; Cohen's d=1.62) better with aDBS than without stimulation. Motor improvement with aDBS occurred despite an average time ...

4.

nature.com

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

Will adaptive deep brain stimulation for Parkinson's ...

Adaptive DBS (aDBS) was conceived to overcome some of the disadvantages of cDBS by facilitating optimized current delivery to improve symptoms ...

5.

news.medtronic.com

news.medtronic.com/Groundbreaking-study-published-in-the-Journal-of-the-American-Medical-Association-JAMA-Neurology-demonstrates-effectiveness-of-Medtronic-BrainSense-TM-Adaptive-deep-brain-stimulation-for-people-with-Parkinsons

Groundbreaking study published in the Journal of ...

It is also the first trial to compare two distinct aDBS modes and evaluate long-term, at-home use of closed-loop DBS in a multicenter setting.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12395746/

Cognitive effects of adaptive deep brain stimulation in ...

This study evaluated the cognitive safety of aDBS in Parkinson's disease (PD). Methods. Sixteen PD patients with bilateral subthalamic DBS ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06012461

NCT06012461 | Closed-loop DBS in Parkinson's Disease

During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop ...