Effects of Deep Brain Stimulation for the Treatment of Parkinson's Disease

Completed

Conditions studied: Parkinson

In brief

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 unilateral stimulation will lead to improvements in bilateral motor functioning.

Key facts

Study ID

NCT00358189

Run by

US Department of Veterans Affairs

People needed

20

Starts

2006-10-01

Expected to finish

2008-05-01

Last updated by the study team

2009-02-05

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Louis Stoke Cleveland VA Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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