To Explore the Intervention Effect of High Definition-transcranial Alternating Current Stimulation (HD-tACS) on Consciousness Promotion in Patients With Chronic Consciousness Disorders and the Potential Neural Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of Coma Recovery Scale
研究概览
简要总结
To investigate the effect of high definition-transcranial alternating current stimulation(HD-tACS) on consciousness promotion in patients with chronic consciousness disorders and the underlying neural mechanism by EEG.
详细描述
Forty patients with chronic consciousness disorder who met the inclusion criteria were recruited with the informed consent of the family. All the participants were randomized to receive "active" or "sham" treatment protocol. Stimulation was performed using a alternating stimulator linked to one anodal electrode and four cathodal electrodes. The anodal electrode was placed over the left dorsolateral prefrontal cortex (DLPFC; F3 in the 10-20 international system of EEG placement), and the four cathodal electrodes (AFz, FCz, F7, and C5 in the 10-20 international system EEG placement) were placed around the anodal electrode to form a current loop. Twenty 2 milliampere (mA) sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 10 consecutive days, and the stimulus frequency was set as 6 Hertz (Hz). Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Before and after the tACS treatment, the state of consciousness was assessed according to coma recovery scale-revised(CRS-R), and19-channel EEG data were collected.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as chronic disorders of consciousness based on CRS-R assessment by at least two professional neurologists;
- •the age requirement is between 18 and 75;
- •vital signs need to be stable;
- •no neuromuscular blockers and sedatives have been used within 24 hours before the study and the entire protocol;
- •no improvement in the state of consciousness was observed within one week before the start of the study.
排除标准
- •previous or current diagnosis of severe neurocognitive degenerative diseases;
- •metal implantation in the head;
- •previous surgical procedures resulted in skull defect;
- •previous history of epilepsy.
研究组 & 干预措施
active group
Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 10 consecutive days, and the stimulus frequency was set as 6Hz.
干预措施: high definition-transcranial alternating current stimulation (Device)
sham group
Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
干预措施: sham transcranial alternating current stimulation (Device)
结局指标
主要结局
Assessment of Coma Recovery Scale
时间窗: Before intervention and one day after all intervention
State of consciousness was assessed by two trained physicians in three different time periods using the Coma Recovery Scale-Revised (CRS-R), which has demonstrated good reliability and validity for the behavioral evaluation of disorder of consciousness (DOC) patients. Total score ranges from zero to twenty-three, with higher scores indicating better neurological function and prognosis.
次要结局
未报告次要终点
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University