Status:
COMPLETED
Effects of Deep Brain Stimulation for the Treatment of Parkinson's Disease
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Parkinson
Eligibility:
All Genders
30-75 years
Brief Summary
The purpose of this study is to assess the effects of unilateral deep brain stimulation on upper and lower extremity motor function in advanced Parkinson's disease patients. It is hypothesized the uni...
Detailed Description
Parkinson's disease (PD) is a chronic progressive degenerative illness in which dopaminergic neurons in the substantia nigra pars compacta deteriorate resulting in a reduction in striatal dopamine. De...
Eligibility Criteria
Inclusion
- a) Patients must have had the Deep Brain Stimulator implanted for at least six months prior to enrollment.
- Hoehn and Yahr stage III or worse when off stimulation and medication
- Intractable, disabling motor fluctuations, dyskinesias or freezing episodes
- Age between 30-75 years
- Normal cognition
- Demonstrated good response to levodopa. In order to exclude patients with Parkinson's plus (i.e. progressive supranuclear palsy, multiple system atrophy, striato-nigral degeneration, etc) all patients included in this study must have demonstrated a good response to levodopa, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based on UPDRS motor examination subscore following the administration of levodopa during their screening neurological exam.
- Unsatisfactory clinical response to maximal medical management A stable and optimal medical regimen of antiparkinsonian drug therapy for at least three months prior to or after surgery
Exclusion
- Clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
- Evidence of secondary or atypical parkinsonism as suggested by:
- History of CVA's, exposure to toxins, neuroleptics or encephalitis
- Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy or significant orthostatic hypertension
- Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain
- Use of DBS for psychiatric disorder (obsessive compulsive or depression)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00358189
Start Date
October 1 2006
End Date
May 1 2008
Last Update
February 5 2009
Active Locations (1)
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1
Louis Stoke Cleveland VA Medical Center
Cleveland, Ohio, United States, 44195