Parkinson Disease
Conditions
Keywords
Parkinson disease, neurologic and psychiatric disorders, rare disease
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREpallidotomy
Sponsors
Emory University
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Outcome results
None listed