NCT01718249已完成不适用
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- CRS-R scores (Coma Recovery Scale-Revised)
研究概览
简要总结
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.
详细描述
Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.
排除标准
- •Cerebral death, Locked-In Syndrome, blindness, deafness
研究组 & 干预措施
deep brain stimulation
Other
干预措施: Implantable neurostimulation system (Other)
结局指标
主要结局
CRS-R scores (Coma Recovery Scale-Revised)
时间窗: after 2 months and after 7 months
次要结局
- signs of awakening at night(during the 10 months of the study)
- zerit burden interview(at 1 month and at 10 months)
研究者
研究点 (1)
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