Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
1994-10-31
Brief Summary
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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
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The other group receives standard medical care for 6 months followed by a pallidotomy.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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pallidotomy
Eligibility Criteria
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Inclusion 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
30 Years
75 Years
ALL
No
Sponsors
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Emory University
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Mahlon R. DeLong
Role: STUDY_CHAIR
Emory University
Other Identifiers
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EUSM-018
Identifier Type: -
Identifier Source: secondary_id
EUSM-409-92
Identifier Type: -
Identifier Source: secondary_id
199/12083
Identifier Type: -
Identifier Source: org_study_id