NCT06851156招募中不适用
An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
Xijing Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年4月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- CRS-R total score changes
研究概览
简要总结
The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.
排除标准
- •patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.
研究组 & 干预措施
Transcranial Temporal Interference Stimulation
Experimental
tTIS is applied over the bilateral CM-pf for 10 days, once a day.
干预措施: tTIS (Device)
结局指标
主要结局
CRS-R total score changes
时间窗: From enrollment to the end of treatment at 10 days
Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition.
次要结局
- EEG changes(From enrollment to the end of treatment at 10 days)
- Numbers of patients with improved consciousness(From enrollment to the end of treatment at 10 days)
研究者
研究点 (2)
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