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Deep Brain Stimulation for Parkinson's Disease Trial
This study is ongoing, but not recruiting participants.
First Received: February 4, 2003   Last Updated: February 1, 2008   History of Changes
Sponsors and Collaborators: The Cleveland Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00053625
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Procedure: deep brain stimulation
Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: Deep Brain Stimulation for Parkinson's Disease Trial

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • UPDRS testing [ Time Frame: followed for 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: June 1999
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
S.A.1: Active Comparator
compare the relative benefit of unilateral DBS in the GPi or STN
Procedure: deep brain stimulation

Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms—most commonly the debilitating symptoms of Parkinson's disease (PD). In Arm S.A.1: Primary outcome variable will be the change in the UPDRS total score from baseline to 6 months post-surgery.

In Arm S.A.2: For bilateral DBS the second implant site will be the same as that for the first procedure (i.e. either STN or GPi) in order to allow comparison between bilateral STN and GPi stimulation.

S.A.2: Active Comparator
access the effect of bilateral GPi or STN stimulation in patients having previously undergone unilateral DBS in the GPi or STN
Procedure: deep brain stimulation

Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms—most commonly the debilitating symptoms of Parkinson's disease (PD). In Arm S.A.1: Primary outcome variable will be the change in the UPDRS total score from baseline to 6 months post-surgery.

In Arm S.A.2: For bilateral DBS the second implant site will be the same as that for the first procedure (i.e. either STN or GPi) in order to allow comparison between bilateral STN and GPi stimulation.


Detailed 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 the 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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

  • Clinical diagnosis of Idiopathic Parkinson's Disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to Levo-dopa therapy.
  • Hoeh & Yahr staging III or worse "off " medication periods.
  • Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes.
  • Unsatisfactory clinical response to maximal medical management or previous surgical treatment.
  • Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence varying no more than +/- twenty percent during the 30 day period.
  • Absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form.

EXCLUSION:

  • Clinically significant medical history that increases pre- / post operative complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes…).
  • Secondary or atypical parkinsonism as suggested by: i. History of stroke, encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen.
  • Dementia as indicated by a Mattis Dementia Rating Scale (DRS) less than 116 or DSM-IV criterion for dementia.
  • Clinically significant psychiatric disorder meeting Structured Clinical Interview for the DSM-IV criteria for an active anxiety, depressive, or psychotic disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053625

Locations
United States, Georgia
Emory University School of Medicine, Neurology Department
Atlanta, Georgia, United States, 30322
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jerrold L Vitek, M.D., Ph.D. Cleveland Clinic Foundation, Director - Functional Neuroscience Research Center
Principal Investigator: Mahlon R. DeLong, M.D. Emory University
  More Information

No publications provided

Responsible Party: Cleveland Clinic ( Jerrold Vitek, M.D., Ph.D. )
Study ID Numbers: R01NS37959
Study First Received: February 4, 2003
Last Updated: February 1, 2008
ClinicalTrials.gov Identifier: NCT00053625     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Parkinson's disease
PD
deep brain stimulation
DBS

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 06, 2009