Science and Technology Innovation 2030
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from resting-state in electroencephalogram
研究概览
简要总结
The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.
详细描述
Analyzed the EEG activity and brain network changes before and after stimulation by TMS stimulation of key brain regions, and correlated them with brain function. To verify the "time-frequency-space" neural mechanism 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Age 14-80 years;(2)In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;(3)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(4) right-handed；(5)The patient's family members signed the informed consent form;
排除标准
- •(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements;
- •Admission criteria for patients with acute disorders of consciousness(Total 300) Inclusion Criteria:（1)Age 14-60 years;（2）Meets diagnostic criteria for coma recognized in international studies；(3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(5) right-handed；(6)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;(5)No spontaneous breathing;(6)Status Epilepticus;(7)Need emergency neurosurgical treatment can not cooperate with the examination;
结局指标
主要结局
Change from resting-state in electroencephalogram
时间窗: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the spectral power and coherence by in resting-state EEG
Change from PCI in electroencephalogram
时间窗: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the perturbational complexity index(PCI) in TMS-EEG
Change from the p300 in electroencephalogram
时间窗: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the p300 in event related potential(ERP)
Change from Coma recovery scale-revised（CRS-R）
时间窗: Assessment within 24 hours before, and 1 hour after TMS treatment
CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness
Change from TEP in electroencephalogram
时间窗: Assessment within 24 hours before, and 1 hour after TMS treatment
Assessment the TMS Evoked Potential(TEP)
Change from ROI in neuroimage techniques-PET
时间窗: Assessment within 24 hours before ,and 1 hour after TMS treatment
The distribution of 18F-FDG in the brain was analyzed according to the imaging situation, and the brain regions of interest (ROI) were outlined, and the uptake of 18F-deoxyglucose (FDG) in the patients was observed according to the brain ROI.
次要结局
未报告次要终点