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Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial

NCT00056563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2014-05-09

Study results available
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Summary

The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving Parkinson's disease symptoms

Conditions

Interventions

DEVICE

Bilateral Deep Brain Stimulation

The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.

OTHER

best medical therapy

Participants will initially be randomized to DBS or to 6 months of "best medical therapy." BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months.

Sponsors & Collaborators

Principal Investigators

  • Kenneth Follett · VA Medical Center, Iowa City

  • Frances M. Weaver, PhD MA BA · Edward Hines Jr. VA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00056563 on ClinicalTrials.gov