Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness
- Conditions
- Disorder of Consciousness
- Interventions
- Device: Transcranial magnetic stimulationDevice: Sham Transcranial magnetic stimulation
- Registration Number
- NCT05682248
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 180
(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;
(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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real rTMS group Transcranial magnetic stimulation True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 10 days; Sham rTMS group Sham Transcranial magnetic stimulation sham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation
- Primary Outcome Measures
Name Time Method Change from resting-state in electroencephalogram 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 Assessment within 24 hours before, and 1 hour after TMS treatment Assessment the perturbational complexity index(PCI) in TMS-EEG
Change from Coma recovery scale-revised（CRS-R） 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 Assessment within 24 hours before, and 1 hour after TMS treatment Assessment the TMS Evoked Potential(TEP)
Change from the p300 in electroencephalogram Assessment within 24 hours before, and 1 hour after TMS treatment Assessment the p300 in event related potential(ERP)
Change from ROI in neuroimage techniques-PET 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xuan Wu hospitial, capical medical university
🇨🇳Beijing, China