Effects of Deep Brain Stimulation for the Treatment of Parkinson's Disease
Deep Brain Stimulation and Motor Function in Parkinson's Patients
1 other identifier
observational
20
1 country
1
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 unilateral stimulation will lead to improvements in bilateral motor functioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
July 31, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFebruary 5, 2009
July 1, 2006
July 28, 2006
February 3, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stoke Cleveland VA Medical Center
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay L Alberts, PhD
Investigator
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
Study Record Dates
First Submitted
July 28, 2006
First Posted
July 31, 2006
Study Start
October 1, 2006
Study Completion
May 1, 2008
Last Updated
February 5, 2009
Record last verified: 2006-07