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Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDNA

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Implantable Neurostimulator for the Treatment of Parkinson's Disease

NCT01839396•Boston Scientific Corporation

Summary

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Detailed Description

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.

Eligibility

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of bilateral idiopathic PD (H\&Y ≥ 2) with a duration of PD ≥ 5 years.
•Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
•Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Exclusion Criteria

•Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
•Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
•Any other active implanted devices including neurostimulators and /or drug delivery pumps
•Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
•Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
•A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

Locations (22)

Muhammad Ali Parkinson Research Center and Movement Disorders Clinic

Phoenix, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Kaiser Permanente, Sacramento

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

Carepoint, PC d/b/a Blue Sky Neurology

Englewood, Colorado, United States

University of Florida Shands Hospital

Gainesville, Florida, United States

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

University of Miami, School of Medicine

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Key Dates

Start Date

May 17, 2013

Primary Completion Date

December 27, 2016

Completion Date

December 5, 2022

Last Updated

July 13, 2023

Enrollment

313

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Deep Brain Stimulation

DEVICE

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations