Study of Brain Function Evaluation and Intervention 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 validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

Detailed Description
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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.

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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* Device: Transcranial magnetic stimulation
* Device: Sham Transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Admission criteria for patients with prolonged disorders of consciousness (Total 200) 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(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;

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real rTMS group<br>True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 7 days; | Device: Transcranial magnetic stimulation<br>* Transcranial magnetic stimulation<br>|
| Placebo Comparator: Sham rTMS group<br>sham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation | Device: Sham Transcranial magnetic stimulation<br>* Sham Transcranial magnetic stimulation<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） | 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 | Assessment within 24 hours before, and 1 hour after TMS treatment | 
| 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 | 
| 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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TMS, Non-invasive neuromodulation, Brain Function Test