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Anodic Stimulation for Parkinson's Disease

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of South Florida
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?

Randomized, double-blind, crossover design, interventional study to assess the differences between mixed cathodic/anodic, pure cathodic, and pure anodic stimulation with respect to efficacy, side effect thresholds, symptom control, and quality of life in Parkinson's Disease patients implanted with Boston Scientific Cartesia directional DBS leads in the bilateral STN.

Who Is on the Research Team?

YB

Yarema Bezchlibnyk

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who already have Boston Scientific Cartesia directional DBS leads implanted in both sides of a specific brain area (STN).

Inclusion Criteria

I am between 40 and 80 years old.
Patients whose DBS settings can be optimized to include anodic and cathodic stimulation
I have Parkinson's and have had Boston Scientific DBS leads in both sides of my brain for 3+ months.

Exclusion Criteria

Patients who are not chronically using anodic stimulation parameters
I have Parkinson's and my DBS leads were placed outside FDA-approved areas.

What Are the Treatments Tested in This Trial?

Interventions

  • Mixed Cathodic/Anodic Stimulation
  • Pure Anodic Stimulation
  • Pure Cathodic Stimulation

Trial Overview

The study compares three types of deep brain stimulation—pure cathodic, pure anodic, and mixed cathodic/anodic—to see which works best for controlling symptoms and improving quality of life. Participants receive each type in random order.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Mixed Cathodic/AnodicExperimental Treatment1 Intervention
Group II: CathodicExperimental Treatment1 Intervention
Group III: AnodicExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Boston Scientific Corporation

Industry Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

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