Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness

Study Overview
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Brief Summary
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The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

Detailed Description
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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;

Official Title
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Science and Technology Innovation 2030

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Other: Routine clinical rehabilitation


Participation Criteria
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Eligibility Criteria
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Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria:(1)Age 14-60 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; 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 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;

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prolonged disorders of consciousness<br>Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria | Other: Routine clinical rehabilitation<br>* Routine clinical rehabilitation<br>|
| Acute disorders of consciousness<br>Admission criteria for patients with acute disorders of consciousness Inclusion Criteria | Other: Routine clinical rehabilitation<br>* Routine clinical rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Coma recovery scale-revised | 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 | Within 24 hours of enrollment | 
| Change from the p300 in electroencephalogram | Assessment the p300 in event related potential(ERP) | Assessment within 24 hours before, and 1 hour after TMS treatment | 
| Change from resting-state in electroencephalogram | Assessment the spectral power and coherence by in resting-state EEG | Assessment within 24 hours before, and 1 hour after TMS treatment | 
| Change from TEP in electroencephalogram | Assessment the TMS Evoked Potential(TEP) | Assessment within 24 hours before, and 1 hour after TMS treatment | 
| Change from PCI in electroencephalogram | Assessment the perturbational complexity index(PCI) in TMS-EEG | Assessment within 24 hours before, and 1 hour after TMS treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from ROI in neuroimage techniques-PET | 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. | Assessment within 24 hours before ,and 1 hour after TMS treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Function Test