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

Science and Technology Innovation 2030

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06097013
Enrollment
500
Registered
2023-10-24
Start date
2022-04-13
Completion date
2026-11-30
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

Brain Function Test

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;

Interventions

OTHERRoutine clinical rehabilitation

Routine clinical rehabilitation

Sponsors

Tianjin University
CollaboratorOTHER
Jilin University
CollaboratorOTHER
Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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;

Design outcomes

Primary

MeasureTime frameDescription
Change from Coma recovery scale-revisedWithin 24 hours of enrollmentCRS-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 electroencephalogramAssessment within 24 hours before, and 1 hour after TMS treatmentAssessment the p300 in event related potential(ERP)
Change from resting-state in electroencephalogramAssessment within 24 hours before, and 1 hour after TMS treatmentAssessment the spectral power and coherence by in resting-state EEG
Change from TEP in electroencephalogramAssessment within 24 hours before, and 1 hour after TMS treatmentAssessment the TMS Evoked Potential(TEP)
Change from PCI in electroencephalogramAssessment within 24 hours before, and 1 hour after TMS treatmentAssessment the perturbational complexity index(PCI) in TMS-EEG

Secondary

MeasureTime frameDescription
Change from ROI in neuroimage techniques-PETAssessment within 24 hours before ,and 1 hour after TMS treatmentThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026