NCT01076452

Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial

CSP #468 Phase II - A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease, Phase II

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Deep Brain Stimulation (DBS) is a promising therapy for Parkinson's disease (PD) Whether DBS is superior to comprehensive best medical therapy or whether some patients or symptoms respond better to DBS in one area of the brain or the other is currently not known. The goals of this project are to compare the effectiveness of DBS and comprehensive medical therapy as treatments for PD (Phase I) and to compare bilateral DBS at 2 areas of the brain-the subthalamic nucleus (STN) and the globus pallidus (GPi) -to determine the most effective brain site for surgical intervention (Phase II) In this prospective, randomized, multi-center trial, 316 patients will be enrolled at 13 centers over four and a half years. Patients will initially be randomized to immediate surgery (DBS) or to 6 months of "best medical therapy". BMT arm patients will then be randomized to proceed into the DBS surgical phase of the trial. The DBS site (STN pr GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. Patients will be followed for two years post surgery (24 months for DBS only patients and 30 months for BMT-DBS patients) Effective 8/5/05 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. The findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of PD.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-04-01
• Primary completion: 2008-10-01
• Completion: 2009-04-01
• First posted: 2010-02-26
• Last updated: 2014-07-14
• Results posted: 2014-01-15

Locations

14 sites across 1 country: United States