Effect and Mechanism of HD-tDCS Combined With Circadian Rhythm Remodeling on Consciousness Recovery in Patients With Chronic Disorder of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Resting state fMRI
研究概览
简要总结
The circadian rhythm characteristics of sleep cycle and neuroendocrine in patients with chronic disorder of consciousness show different degrees of disorder, and the relationship between this disorder and consciousness level is unclear.The researchers used HD-tDCS to treat patients with chronic disturbance of consciousness who intervened in circadian rhythm, and used a variety of methods such as EEG, fMRI, protein metabolism, ERP and micro-expression to explore the mechanism of improving the state of consciousness of HD-DCS and the relationship between circadian rhythm and patients' consciousness level
详细描述
The sleep status (> 24 hours) of patients with chronic disturbance of consciousness was recorded with the revised coma recovery scale revised (CRS-R) and Polysomnography (PSG). The sleep cycle of patients with chronic disturbance of consciousness was judged by the open and close eyes cycle and EEG.
Patients with circadian rhythm treated with or without blue light stimulation and melatonin were treated with HD-tDCS. EEG, fMRI, protein metabolism, ERP and micro expression data were recorded before and after treatment.Explore the mechanism of improving the state of consciousness of HD-DCS and the relationship between circadian rhythm and patients' consciousness level
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •Patients with diagnosis of disorder of consciousness
- •Stable vital signs
- •Good coordination, less spontaneous activity
- •No anti-epileptic and sedative drugs taken within prior 24 hours
- •The family members volunteered and signed the informed consent
排除标准
- •locked-in syndrome
- •Diseases and factors that may affect the judgment of brain function, such as metabolic diseases, poisoning, shock, etc.
- •There are contraindications to MRI scanning, such as the presence of metal implants in the body
- •Contraindications treated by transcranial direct current stimulation
研究组 & 干预措施
tDCS and melatonin intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. Participants were given a 3-mg fast-release oral dose of melatonin.
干预措施: Melatonin (Drug)
tDCS and melatonin intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. Participants were given a 3-mg fast-release oral dose of melatonin.
干预措施: HD-tDCS (Other)
tDCS intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
干预措施: Placebo (Other)
tDCS intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
干预措施: HD-tDCS (Other)
Melatonin intervention
Participants were given a 3-mg fast-release oral dose of melatonin.
干预措施: Melatonin (Drug)
Control
Patients were treated with the placebo and sham-tDCS.
干预措施: Placebo (Other)
结局指标
主要结局
Resting state fMRI
时间窗: Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.
Resting state fMRI reflects the brain activity occured in a resting or task-negative state. Regional (ReHo, ALFF, fALFF, etc.) and global parameters (functional connectivity, etc.) could be used in this study.
The Coma Recovery Scale-Revised (CRS-R) scale
时间窗: Change from Baseline CRS-R at 14 days.
The CRS-R is a tool used to characterise the level of consciousness consisting of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The values range from 0 to 23, with higher score indicating better outcome.
Electroencephalography (EEG)
时间窗: Change from baseline EEG power spectral density at 14 days.
Delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz). An increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery.
Sleep parameters
时间窗: Change from baseline sleep patterns at 14 days.
Changes in in sleep/wake architecture assessed by polysomnography. Electrodes attached to the scalp near the frontal, central (top) and occipital (back) portions of the brain and provide a readout of different stages of sleep (N1, N2, N3, REM, and Wakefulness).
Micro-expression
时间窗: At baseline.
After listening to auditory stimulations, transient alterations may occur on the micro expression of the subjects. High-resolution video will be taken to capture each subject's facial micro-expressions while listening to the auditory materials.
次要结局
- protein metabolism(Change from Baseline protein metabolism at 14 days.)