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

Primary Purpose

Disorder of Consciousness

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sham Transcranial magnetic stimulation
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness focused on measuring TMS, Non-invasive neuromodulation, Brain Function Test

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Admission criteria for patients with prolonged disorders of consciousness (Total 200) 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(Total 300) 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;

Sites / Locations

  • Xuan Wu hospitial, capical medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Real rTMS group

Sham rTMS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Coma recovery scale-revised（CRS-R）
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 the p300 in event related potential(ERP)
Change from resting-state in electroencephalogram
Assessment the spectral power and coherence by in resting-state EEG
Change from TEP in electroencephalogram
Assessment the TMS Evoked Potential(TEP)
Change from PCI in electroencephalogram
Assessment the perturbational complexity index(PCI) in TMS-EEG
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.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2022
Last Updated
October 18, 2023
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Tianjin University, Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT05682248
Brief Title
Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness
Official Title
Science and Technology Innovation 2030
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Tianjin University, Jilin University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
TMS, Non-invasive neuromodulation, Brain Function Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real rTMS group
Arm Type
Experimental
Arm Description
True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 7 days;
Arm Title
Sham rTMS group
Arm Type
Placebo Comparator
Arm Description
sham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
Sham Transcranial magnetic stimulation
Intervention Description
Sham Transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Change from Coma recovery scale-revised（CRS-R）
Description
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
Time Frame
Assessment within 24 hours before, and 1 hour after TMS treatment
Title
Change from the p300 in electroencephalogram
Description
Assessment the p300 in event related potential(ERP)
Time Frame
Assessment within 24 hours before, and 1 hour after TMS treatment
Title
Change from resting-state in electroencephalogram
Description
Assessment the spectral power and coherence by in resting-state EEG
Time Frame
Assessment within 24 hours before, and 1 hour after TMS treatment
Title
Change from TEP in electroencephalogram
Description
Assessment the TMS Evoked Potential(TEP)
Time Frame
Assessment within 24 hours before, and 1 hour after TMS treatment
Title
Change from PCI in electroencephalogram
Description
Assessment the perturbational complexity index(PCI) in TMS-EEG
Time Frame
Assessment within 24 hours before, and 1 hour after TMS treatment
Title
Change from ROI in neuroimage techniques-PET
Description
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.
Time Frame
Assessment within 24 hours before ,and 1 hour after TMS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Admission criteria for patients with prolonged disorders of consciousness (Total 200) 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(Total 300) 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;
Facility Information:
Facility Name
Xuan Wu hospitial, capical medical university
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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