Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease
Completed · Not applicable
Conditions studied: Parkinson Disease
In brief
The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.
Key facts
- Study ID
- NCT00360009
- Run by
- University of Florida
- People needed
- 62
- Starts
- 2004-01-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2012-10-31
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Intractable, disabling PD with motor fluctuations, dyskinesias, or freezing episodes
- Age between 30-75 years
- Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-Parkinsonian drugs)
- A stable and optimal medical regimen of anti-Parkinsonian drug therapy for at least three months prior to surgery
- Patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.
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 the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension
- MRI scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)
- The Mattis Dementia Rating Scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia
- A major psychiatric disorder on the Structured Clinical Interview for DSM-IV (SCID-IV).
Where it is running
- University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100 — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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