Deep Brain Stimulation for Parkinson's Disease Trial

Status Completed

Clinical Trial 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 Parkinson's disease.

Clinical Trial Description

Medical therapy is the mainstay of treatment for patients with Parkinson's 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00053625
Study type	Interventional
Source	University of Minnesota - Clinical and Translational Science Institute
Contact
Status	Completed
Phase	Phase 3
Start date	June 1999
Completion date	June 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02915848` - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting	`NCT03648905` - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Terminated	`NCT02688465` - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).	Phase 4
Completed	`NCT05040048` - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Active, not recruiting	`NCT04006210` - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations	Phase 3
Completed	`NCT02562768` - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease	Phase 1
Completed	`NCT00105521` - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia	Phase 3
Completed	`NCT00105508` - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia	Phase 3
Recruiting	`NCT06002581` - Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease	N/A
Completed	`NCT02236260` - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation	N/A
Completed	`NCT00529724` - Body Weight Gain, Parkinson, Subthalamic Stimulation	Phase 2
Active, not recruiting	`NCT05699460` - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Completed	`NCT03703570` - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations	Phase 2
Completed	`NCT03462680` - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures	N/A
Completed	`NCT02837172` - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting	`NCT04046276` - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease	N/A
Recruiting	`NCT02952391` - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol	N/A
Active, not recruiting	`NCT02937324` - The CloudUPDRS Smartphone Software in Parkinson's Study.	N/A
Terminated	`NCT02924194` - Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease	N/A
Completed	`NCT02927691` - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial	Phase 2