Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056563
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2003-03-18
Brief Title:
Phase I Deep Brain Stimulation DBS vs Best Medical Therapy BMT Trial
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 468 Phase I - A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons disease and if deep brain stimulation or best medical therapy is more effective in improving Parkinsons disease symptoms
Detailed Description:
Deep Brain Stimulation DBS is a promising therapy for Parkinsons 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 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 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 patients will then proceed into the surgical phase of the trial 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 Patients will be followed for two years post surgery 24-30 months Effective 080505 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None