Closed Loop DBS for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Helen M Bronte-Stewart, MD MSE

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Dementia, Untreated psychiatric disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait deficits and freezing of gait may initially respond to continuous open-loop deep brain stimulation (olDBS) and medication, the symptoms often recur over time. The episodic and predictable nature of FOG makes it well suited for adaptive DBS (aDBS) and a device that overcomes the limitations of traditional high frequency olDBS and is capable of adapting therapy either in the frequency or intensity domain transiently to treat FOG while also treating other PD signs such as tremor and bradykinesia. The purpose of this study is to determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters.

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 data supports the idea that Closed Loop DBS for Parkinson's Disease is an effective treatment?

The available research shows that Closed Loop DBS, also known as Adaptive DBS, is effective in treating Parkinson's Disease by using feedback from brain signals to adjust stimulation. This method can lead to significant improvements in motor symptoms, as seen in trials where it improved motor scores more than conventional DBS. It also reduces side effects and extends battery life by using less continuous stimulation. Studies on animals, like rats, have shown that Closed Loop DBS can be more effective than traditional methods, suggesting its potential benefits for humans. ^{1 2 3 4 5}

What safety data exists for closed-loop DBS in Parkinson's Disease?

Closed-loop adaptive deep brain stimulation (aDBS) has been shown to reduce stimulation time and side effects compared to conventional DBS (cDBS). Studies indicate that aDBS is at least as effective as cDBS, with reduced side effects and energy consumption. Common complications of DBS devices include infections, lead migrations, and device malfunctions, with a significant portion requiring surgical intervention. Further research is needed to address these complications and improve device reliability. ^{5 6 7 8 9}

Is Bilateral Closed Loop Deep Brain Stimulation a promising treatment for Parkinson's Disease?

Yes, Bilateral Closed Loop Deep Brain Stimulation is a promising treatment for Parkinson's Disease. It can improve motor symptoms by adjusting the stimulation based on the patient's condition, leading to better control of symptoms and fewer side effects compared to traditional methods. It also uses less energy, which can extend the life of the device used in the treatment. ^{1 4 5 6 10}

Research Team

Helen M Bronte-Stewart, MD MSE

Principal Investigator

Stanford University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Bilateral Closed Loop Deep Brain Stimulation (Procedure)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Stanford, CA

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

Bilateral adaptive deep brain stimulation (aDBS) significantly improved motor symptoms in Parkinson's disease patients, with a 43% reduction in Unified Parkinson's Disease Rating Scale (UPDRS) scores compared to no stimulation, indicating its efficacy.

The improvements were achieved even with only 45% of the time on stimulation and while patients were concurrently taking levodopa, suggesting that aDBS can effectively adapt to the patient's needs and enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. Little, S., Beudel, M., Zrinzo, L., et al.[2022]

Adaptive deep brain stimulation (aDBS) offers a promising advancement over conventional deep brain stimulation (cDBS) for treating Parkinson's Disease by allowing real-time adjustments to stimulation parameters based on the patient's clinical state.

The effectiveness of aDBS heavily relies on the selection of control variables and algorithms, which presents challenges in system design and implementation, highlighting the need for careful consideration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adaptive deep brain stimulation challenge. Arlotti, M., Rosa, M., Marceglia, S., et al.[2018]

References

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

Efficient suppression of parkinsonian beta oscillations in a closed-loop model of deep brain stimulation with amplitude modulation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. [2022]

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

On-Off and Proportional Closed-Loop Adaptive Deep Brain Stimulation Reduces Motor Symptoms in Freely Moving Hemiparkinsonian Rats. [2023]

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

Adaptive deep brain stimulation (aDBS) controlled by local field potential oscillations. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Toward adaptive deep brain stimulation in Parkinson's disease: a review. [2019]

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

Eight-hours conventional versus adaptive deep brain stimulation of the subthalamic nucleus in Parkinson's disease. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

The adaptive deep brain stimulation challenge. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Adaptive deep brain stimulation as advanced Parkinson's disease treatment (ADAPT study): protocol for a pseudo-randomised clinical study. [2022]

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

Dual threshold neural closed loop deep brain stimulation in Parkinson disease patients. [2019]