Directional Deep Brain Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen byHarrison Walker, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the clinical efficacy of directional DBS electrode technology and whether electrophysiology biomarkers can predict effective contact segments for chronic therapy.

Eligibility Criteria

This trial is for adults aged 18-70 with advanced Parkinson's Disease who've had symptoms for at least 4 years and experience significant disability despite medication. They must be healthy enough for surgery, have stable medication doses, show improvement on dopaminergic meds, and not need contralateral DBS within a year. Exclusions include severe depression, other neurological diseases, medical conditions that interfere with the study or require MRI, uncontrolled health issues like hypertension or heart disease.

Inclusion Criteria

My daily activities are severely impacted by my condition, even with medication.

Participant expresses understanding of the consent process, terms of the study protocol, is available for follow-up over the length of the study, and signs informed consent

I have Parkinson's with tremor, stiffness, or slow movement.

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Exclusion Criteria

Score of >25 on the Beck Depression Inventory II, with scores ranging from 0 to 63 and higher scores indicating worse functioning), or history of suicide attempt

Ongoing or pervasive impulse control disorder not resolved by reduction of dopaminergic medications

I am on blood thinners that can't be stopped for surgery.

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Treatment Details

Interventions

Boston Scientific Vercise PC IPG with directional DBS lead (Deep Brain Stimulation)

Trial OverviewThe trial tests the Boston Scientific Vercise PC IPG with directional DBS lead to see if it improves Parkinson's symptoms. It also examines whether certain biomarkers can predict which electrode contacts will work best long-term. Participants are those already opting for routine DBS surgery targeting the subthalamic nucleus.

Participant Groups

3Treatment groups

Active Control

Placebo Group

Group I: Directional DBS guided by behaviorActive Control1 Intervention

Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.

Group II: Directional DBS guided by biomarkersActive Control1 Intervention

Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).

Group III: Omnidirectional DBS guided by behaviorPlacebo Group1 Intervention

Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.