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

Science and Technology Innovation 2030

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Device: Transcranial magnetic stimulation; Device: Sham Transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham rTMS group; sham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation	Device: Sham Transcranial magnetic stimulation; Sham Transcranial magnetic stimulation
Experimental: Real rTMS group; True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 10 days;	Device: Transcranial magnetic stimulation; Transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessment within 24 hours before, and 1 hour after TMS treatment
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 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
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

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: November 13, 2022
• First Submitted That Met QC Criteria: December 26, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: TMS; Non-invasive neuromodulation; Brain Function Test
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: 2021ZD0204305

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
• product manufactured in and exported from the U.S.: No