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

Disorder of Consciousness Clinical Trial

Official title:

Science and Technology Innovation 2030

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05682248
• Other study ID #: 2021ZD0204305
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: November 2026

Study information

• Verified date: December 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: November 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Admission criteria for patients with prolonged disorders of consciousness (Total 200) Inclusion Criteria:(1)Age 14-80 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;

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness

Intervention

Device:
• Transcranial magnetic stimulation
Transcranial magnetic stimulation
• Sham Transcranial magnetic stimulation
Sham Transcranial magnetic stimulation

Locations

Country	Name	City	State
China	Xuan Wu hospitial, capical medical university	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Jilin University, Tianjin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change from TEP in electroencephalogram	Assessment the TMS Evoked Potential(TEP)	Assessment within 24 hours before, and 1 hour after TMS treatment
Primary	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
Primary	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