Phase II Study of Pallidotomy for Parkinson Disease

National Center for Research Resources (NCRR)60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Parkinson Disease

Interventions

pallidotomyPROCEDURE

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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