Deep Brain Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen byDoris D Wang, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Doris Wang, MD, PhD

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

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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

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Participant Groups

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.

3Treatment groups

Active Control

Group I: Adaptive deep brain stimulation (ramp-up)Active Control1 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 Control1 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 stimulationActive Control1 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.