Adaptive DBS for Parkinson's Disease

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Doris Wang, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-center clinical study aiming to improve gait functions in patients with Parkinson's Disease (PD) by using adaptive neurostimulation to the pallidum. The investigators will use a bidirectional deep brain stimulation device with sensing and stimulation capabilities to 1) identify neural biomarkers to detect the onset of walking by recording neural activities from the motor cortical areas and the globus pallidus, 2) understand the impacts of changes in DBS parameters on gait kinematics and optimize setting parameters for enhancing walking performance, 3) develop a movement state-dependent adaptive deep brain stimulation (DBS) paradigm to automatically switch stimulation settings according to different movement states (i.e., walking vs non-walking). The proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance gait function in patients with PD. 6 patients with idiopathic Parkinson's disease who have already been implanted with the Medtronic Summit RC+S device will be enrolled in this study.

Who Is on the Research Team?

DW

Doris Wang, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 21 and 75 years old.
I have had idiopathic Parkinson's disease symptoms for at least 3 years.
I tried oral medications, but they did not relieve my symptoms.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive and open-loop DBS settings randomized for 7-day periods to evaluate gait and motor function improvements

14 days
Daily home-based motor and gait tasks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Summit RC+S

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Continuous (open-loop) deep brain stimulationActive Control1 Intervention
Group II: Movement state-dependent adaptive (closed-loop) deep brain stimulationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Doris Wang, MD, PhD

Lead Sponsor

Trials
2
Recruited
30+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials
117
Recruited
537,000+

Burroughs Wellcome

Industry Sponsor

Trials
8
Recruited
2,800+