A Multi-center Randomised Controlled Trial to Explore the Ideal Stimulation Strategies at Hand Twelve Jing-Well Points in Patients With Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Coma Recovery Scale-Revised (CRS-R) change
研究概览
简要总结
The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old
- •From 7 to 90 days since brain injury
- •Diagnosed in VS/UWS or MCS as defined by at least two CRS-R assessments performed during the screening period
- •Acquired cerebral damage of known etiology
- •Intact hand skin
- •Informed consent given by the legal surrogate
排除标准
- •Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
- •History of previous serious、progressive neurological disorder prior to the brian injury
- •Epilepsy and seizure
- •Unstable vital signs or life-threatening comorbidities
- •Active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc)
- •Documented pregnancy
研究组 & 干预措施
Control
Control group was treated with conventional medical treatment.
Bloodletting Puncture
Bloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.
干预措施: Bloodletting Acupuncture (Other)
Transcutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.
干预措施: Transcutaneous electrical stimulation (Device)
结局指标
主要结局
Coma Recovery Scale-Revised (CRS-R) change
时间窗: baseline, immediately after the end of the 5-day treatment
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
次要结局
- ABCD model change(baseline, immediately after the end of the 5-day treatment)
- ABCD model change(baseline, immediately after the end of the first treatment)
- Coma Recovery Scale-Revised (CRS-R) change(baseline, immediately after the end of the first treatment)
- Glasgow Outcome Scale-Extended (GOSE)(at six months post enrollment)
- Consciousness level change(baseline, at six months post enrollment)
- Correlation between EEG responsiveness and long-term outcomes(on the first day, the fifth day and at six months post enrollment)
- Incidence of Adverse Events(from the first treatment to the end of the fifth treatment)