ISRCTN16511360已完成2 期
Deep brain stimulation of the pedunculopontine nucleus for Parkinson's Disease: a single centre randomised interventional treatment trial
orth Bristol NHS Trust (UK)0 个研究点目标入组 8 人开始时间: 2010年5月28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
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of advanced idiopathic Parkinson's disease poorly controlled on optimum medication with significant functional disability and predominant symptoms of postural instability and gait dysfunction in both the on and off medication states
- •2. They will have a Unified Parkinson's Disease Rating Scale (UPDRS) motor score of 30 or greater in their practically defined off condition at an initial evaluation. They will each show at least a 30% improvement in the UPDRS motor score from that of the practically defined off condition following a morning levodopa challenge.
- •3. At two preoperative evaluations the practically defined off UPDRS motor score should differ no more than +/- 15%
- •4. Subjects will be under the age of 70 years, either sex
- •5. Appropriate surgical candidate with no medical conditions that would interfere with long-term implantation of device and follow up
- •6. Patient must give signed informed consent
排除标准
- •1. Known current or past diabetes
- •2. Evidence of dementia, head trauma or medical conditions that may alter cerebral functioning
- •3. Past or present history of alcohol or substance abuse
- •4. Mini-mental state examination (MMSE) scores below 27 or above 30
- •5. Evidence of past or current serious psychopathology likely to affect the patients ability to benefit from surgery
研究者
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