NCT00004670已完成2 期
Phase II Study of Pallidotomy for Parkinson Disease
National Center for Research Resources (NCRR)0 个研究点目标入组 60 人开始时间: 1994年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.:
- •Cardiopulmonary disease
排除标准
- 未提供
研究者
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