Status:
COMPLETED
Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.
Detailed Description
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and the globus pallidus interna (GPi) has been shown to relieve the motor symptoms of Parkinson's disease (PD) such as tremor, rigidity, a...
Eligibility Criteria
Inclusion
- 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.
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 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).
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00360009
Start Date
January 1 2004
End Date
April 1 2008
Last Update
October 31 2012
Active Locations (1)
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1
University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100
Gainesville, Florida, United States, 32610-0236