Deep Brain Stimulation for Parkinson's Disease Trial - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Deep Brain Stimulation for Parkinson's Disease Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Mean change in total UPDRS score (baseline to six-months post DBS surgery) [ Time Frame: Followed for minimum of 5 years ] [ Designated as safety issue: No ]
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others. The mean change from baseline to six months after DBS surgery for patients with DBS in the GPi vs the STN will be compared after being adjusted for differences in age and time since PD diagnosis.

Secondary Outcome Measures:

Mean change in UPDRS subscales and individual scores [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Subscales include domains including behavior and mood, activities of daily living, motor function, complications of therapy and others.

Individual scores to be evaluated include scores for tremor, rigidity, bradykensia, gait, and postural stability.

Other secondary endpoints include: Hoehn and Yahr staging, Modified Schwab and England Scale, timed test results, scores from psychiatric and quality of life assessments.

Enrollment:	123
Study Start Date:	June 1999
Study Completion Date:	June 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: SA #1 Arm 1: Unilateral DBS in GPi	Procedure: deep brain stimulation Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood. Other Name: DBS
Active Comparator: SA #1 Arm 2: Unilateral DBS in STN	Procedure: deep brain stimulation Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood. Other Name: DBS
Active Comparator: SA #2 Arm 1: Bilateral DBS in GPi Patients with GPi bilateral DBS (previously had unilateral DBS in the GPi, now have bilateral DBS in GPi)	Procedure: deep brain stimulation Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood. Other Name: DBS
Active Comparator: SA #2 Arm 2: Bilateral DBS in STN Patients with STN bilateral DBS (previously had unilateral DBS in the STN, now have bilateral DBS in STN)	Procedure: deep brain stimulation Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood. Other Name: DBS

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 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 levodopa 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

University of Minnesota - Clinical and Translational Science Institute

National Institute of Neurological Disorders and Stroke (NINDS)

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:	Jerrold L. Vitek, M.D., Ph.D., University of Minnesota
ClinicalTrials.gov Identifier:	NCT00053625 History of Changes
Other Study ID Numbers:	R01NS37959
Study First Received:	February 4, 2003
Last Updated:	June 27, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Parkinson's disease
PD
deep brain stimulation
DBS

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 18, 2013