Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial
NCT01076452 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299
Last updated 2014-07-14
Summary
The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's Disease.
Conditions
Interventions
- DEVICE
-
Bilateral Deep Brain Stimulation
The DBS site (STN or GPi) was assigned on a random basis at the time the patient enters the surgical phase of the trial.
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH - collaborator INDUSTRY
-
US Department of Veterans Affairs
lead FED
Principal Investigators
-
Kenneth Follett · VA Medical Center, Iowa City
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-04-30
- Primary Completion
- 2008-10-31
- Completion
- 2009-04-30
Countries
- United States
Study Locations
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