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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05682248
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
59
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

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, and validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial magnetic stimulation
  • Device: Sham Transcranial magnetic stimulation
 N/A

Detailed Description

A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with prolonged disorders of consciousness. 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; 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Science and Technology Innovation 2030
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Real rTMS group

True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 7 days;

Device: Transcranial magnetic stimulation
Transcranial magnetic stimulation
Placebo Comparator: Sham rTMS group

sham stimulation group : intesity :0; other parameters are the same as true rTMS stimulation

Device: Sham Transcranial magnetic stimulation
Sham Transcranial magnetic stimulation

Outcome Measures

Primary Outcome Measures

  1. 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

  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 coherenceby 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

  6. 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
Inclusion Criteria:

  • Age 14-60 years

  • The diagnosis was in accordance with the diagnostic criteria of coma（the GCS score was less than 8） recognized by international research，Unresponsive arousal syndrome/vegetative state, minimally conscious state

  • Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness

  • The patient's family members signed the informed consent form

Exclusion Criteria:

  • The history of mental illness and a history of hearing impairment

  • Intracranial arterial clamp, pacemaker and other metal implants

  • During the experiment, sedatives and other drugs that affect the excitability of the cortex

  • The presence of uncontrolled seizures or involuntary movements

  • No spontaneous breathing

  • Status Epilepticus

  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT05682248
Other Study ID Numbers:
  • 2021ZD0204305
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 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
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Xuanwu Hospital, Beijing
TMS
Non-invasive neuromodulation
Brain Function Test
Additional relevant MeSH terms:
Consciousness Disorders

Study Results

No Results Posted as of Jan 12, 2023