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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06097013
Collaborator
Tianjin University (Other), Jilin University (Other)
500
1
54.6
9.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Science and Technology Innovation 2030
Actual Study Start Date :
Apr 13, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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)

  3. 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

  4. Change from TEP in electroencephalogram [Assessment within 24 hours before, and 1 hour after TMS treatment]

    Assessment the TMS Evoked Potential(TEP)

  5. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuan Wu hospitial, capical medical university Beijing China

Sponsors and Collaborators

  • Xuanwu Hospital, Beijing
  • Tianjin University
  • Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT06097013
Other Study ID Numbers:
  • 2021ZD0204300
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xuanwu Hospital, Beijing
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023