Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053625
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2003-02-04
Brief Title:
Deep Brain Stimulation for Parkinsons Disease Trial
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Deep Brain Stimulation for Parkinsons Disease Trial
Status:
COMPLETED
Status Verified Date:
2015-04
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 purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus Gpi and the subthalamic nucleus STN on motor neuropsychological and psychiatric function and quality of life in patients with Parkinsons disease
Detailed Description:
Medical therapy is the mainstay of treatment for patients with Parkinsons disease PD After several years of drug therapy however a large proportion of patients experience worsening of their parkinsonism and develop incapacitating motor fluctuations and dyskinesias To deal with this attention has been directed to surgical procedures such as deep brain stimulation DBS Recently stimulating the areas of the brain that control movement the globus pallidus Gpi and subthalamic nucleus STN has been proposed as a therapy for treating many of the disabling symptoms associated with PD and drug-induced side effects
The major aim of this 5-year study is to carry out a prospective double blinded randomized clinical trial of DBS for medically intractable PD The study will evaluate the effect of DBS in the Gpi and STN on motor neuropsychological and psychiatric function and quality of life in patients with PD The study also will address two key issues 1 whether there are differences between unilateral Gpi-DBS and STN-DBS and 2 which patients are the best candidates for bilateral DBS
The major aim of this 5-year study is to carry out a prospective double blinded randomized clinical trial of DBS for medically intractable PD The study will evaluate the effect of DBS in the Gpi and STN on motor neuropsychological and psychiatric function and quality of life in patients with PD The study also will address two key issues 1 whether there are differences between unilateral Gpi-DBS and STN-DBS and 2 which patients are the best candidates for bilateral DBS
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