A Prospective Randomized Controlled Study of the Efficacy of tDCS and rTMS in Promoting Wakefulness in Patients With Early Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- CRS-R
研究概览
简要总结
A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). In order to improve the prognosis of DOC patients with nontraumatic brain injury, we compared the effects of tDCS and rTMS on clinical behavior and neurophysiological performance, and selected a wake-up technique that could improve the prognosis of DOC patients with nontraumatic brain injury as early as possible, so as to reduce the pain of patients and their loved ones, and to reduce the economic burden of society and families.
详细描述
To study the efficacy of wakefulness promotion in patients with acute DOC due to severe non-traumatic brain injury (including stroke and ischemic-hypoxic encephalopathy), patients with early DOC were randomly divided into conventional treatment group, tDCS treatment group and rTMS treatment group for 14 consecutive days. Clinical scoring, evoked potential assessment, resting-state high-density electroencephalogram(EEG) and TMS-EEG assessment with functional analysis of brain network connectivity were applied for multidimensional assessment of brain function before and after wake-up promotion treatment (day 1 and day 15 of enrollment) to explore non-invasive brain stimulation(NIBS) techniques that can be performed at the bedside - tDCS, rTMS intervention The prognostic follow-up was performed at 3 months, 6 months and 12 months after DOC to compare the awakening rate after tDCS and rTMS prolongation treatment, and to preferably select an effective prolongation technique for early DOC. The safety of tDCS and rTMS was also clarified by comparing the differences in adverse effects and complications between tDCS treatment group and rTMS treatment group and conventional treatment group.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI)
- •DOC, Glasgow coma score (GCS) <12 4.2-4 weeks of DOC
- •5.informed consent obtained from the patient's legal representative.
排除标准
- •foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site)
- •pacemaker or cochlear implants
- •history of epilepsy and family history of epilepsy
- •large cranial defects
- •significant cerebral edema lesions in both DLPFC
- •pregnant women
- •with severe physical diseases such as heart, lung, liver and kidney
- •brain death
- •new intracerebral lesions in patients during the study period affecting the assessment and prognosis, e.g. new stroke
研究组 & 干预措施
tDCS treatment group
On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.
干预措施: tDCS (Device)
rTMS treatment group
On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.
干预措施: rTMS (Device)
conventional treatment group
Not receiving any neuromodulation treatment.
结局指标
主要结局
CRS-R
时间窗: day 15 of enrollment
The unabbreviated scale title is the coma recovery scale-revised.The CRS-R tests six components: auditory, language, visual, communication, motor and arousal levels, with a total score of 0-23. The lower the score, the more severe the brain damage and the deeper the DOC level.
次要结局
- Prognostic scores (mRS)(3 months, 6 months, 12 months after DOC)
- Prognostic scores (CRS-R)(3 months, 6 months, 12 months after DOC)
- ABCD model of neural oscillation(day 15 of enrollment)
- brain network transfer entropy(day 15 of enrollment)
- brain network phase synchronization(day 15 of enrollment)
- GCS(day 15 of enrollment)
- FOUR(day 15 of enrollment)
- MMN(day 15 of enrollment)
- MEP(day 15 of enrollment)
- Prognostic scores (GOS)(3 months, 6 months, 12 months after DOC)