Science and Technology Innovation 2030
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from TEP in electroencephalogram
研究概览
简要总结
The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.
详细描述
A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with acute and prolonged disorders of consciousness(DOC). Based on the multimodal data of three types of patients with DOC, the investigators established a comprehensive scientific collection of brain function features of acute and prolonged consciousness disorders; Revealed the key neural nodes and circuits of consciousness deficits, and elucidated the neural mechanisms of consciousness deficits in patients with prolonged consciousness disorders from EEG time-frequency-spatial features;
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-60 years;
- •In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
- •Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
- •right-handed；
- •The patient's family members signed the informed consent form;
排除标准
- •The history of mental illness and a history of hearing impairment;
- •Intracranial arterial clamp, pacemaker and other metal implants;
- •During the experiment, sedatives and other drugs that affect the excitability of the cortex;
- •The presence of uncontrolled seizures or involuntary movements;
- •Admission criteria for patients with acute disorders of consciousness
- •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:
- •The history of mental illness and a history of hearing impairment;
- •Intracranial arterial clamp, pacemaker and other metal implants;
- •During the experiment, sedatives and other drugs that affect the excitability of the cortex;
- •The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;
- •No spontaneous breathing;
- •Status Epilepticus;
- •Need emergency neurosurgical treatment can not cooperate with the examination;
结局指标
主要结局
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 Coma recovery scale-revised
时间窗: Within 24 hours of enrollment
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 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 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
次要结局
- Change from ROI in neuroimage techniques-PET(Assessment within 24 hours before ,and 1 hour after TMS treatment)