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

NCT01839396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2023-07-13

Study results available
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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.

Conditions

Interventions

DEVICE

Deep Brain Stimulation

The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jerrold Vitek, MD, PhD · University of Minnesota, Neurology Department

  • Philip Starr, MD, PhD · Universiry of California, San Francisco, Surgical Movement Disorders Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-17
Primary Completion
2016-12-27
Completion
2022-12-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01839396 on ClinicalTrials.gov