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

• Conditions: Disorder of Consciousness
• Interventions: Other: Routine clinical rehabilitation

• Registration Number: NCT06097013
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

Detailed Description

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;

Study Timeline

• Study Start: 2022-04-13
• Status Verified: 2023-08
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2024-08
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute disorders of consciousness	Routine clinical rehabilitation	Admission criteria for patients with acute disorders of consciousness Inclusion Criteria
Prolonged disorders of consciousness	Routine clinical rehabilitation	Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria

Primary Outcome Measures

Name	Time	Method
Change from TEP in electroencephalogram	Assessment within 24 hours before, and 1 hour after TMS treatment	Assessment the TMS Evoked Potential(TEP)
Change from Coma recovery scale-revised	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	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	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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xuan Wu hospitial, capical medical university; 🇨🇳 Beijing, China