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

Science and Technology Innovation 2030

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Other: Routine clinical rehabilitation

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuan Wu hospitial, capical medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

prolonged disorders of consciousness and acute disorders of consciousness

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolonged disorders of consciousness; Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria	Other: Routine clinical rehabilitation; Routine clinical rehabilitation
Acute disorders of consciousness; Admission criteria for patients with acute disorders of consciousness Inclusion Criteria	Other: Routine clinical rehabilitation; Routine clinical rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Jilin University; Tianjin University

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Brain Function Test
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: 2021ZD0204300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No