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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.
Full description
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.
Sex
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Inclusion and exclusion 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 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.:
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Data sourced from clinicaltrials.gov
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