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Phase II Study of Pallidotomy for Parkinson Disease



Phase II Study of Pallidotomy for Parkinson Disease

For Condition: Parkinson Disease
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Emory University
Synopsis: OBJECTIVES: I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative assessments vs. delayed pallidotomy following 6 months of standard medical therapy in patients with Parkinson disease.
Details: PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus. The other group receives standard medical care for 6 months followed by a pallidotomy.
Eligibility:
Study Type:  Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 30 Years/75 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic Parkinson disease Hoehn and Yahr stage III or worse during "off" periods Responsive to levodopa by history or exam Sub-optimal clinical response to maximal medication Medication optimized for at least 4 weeks prior to entry No atypical or secondary disease, e.g.: - No history of cerebrovascular accident - No cerebellar involvement - No severe brain atrophy on magnetic resonance imaging No Mattis Dementia Rating Scale score less than 116 No dementia meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria No Hamilton Depression Rating Scale score greater than 10 No Hamilton Anxiety Scale score greater than 14 --Patient Characteristics-- Other: No medical contraindication to surgery, e.g.: - Diabetes - Cardiopulmonary disease
Total Enrollment: 60

Location and Contact Information:

Overall Study Official:
MahlonDeLong,  Study Chair,  Emory University


Additional Information:
Study ID Numbers:  199/12083;  EUSM-018,EUSM-409-92
Study Start Date: October 1994
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004670

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