Clinical trial NCT05682248: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Disorder of Consciousness
Keywords: TMS
Non-invasive neuromodulation
Brain Function Test
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Tianjin University
name: Jilin University
First posted: 2023-01-12
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change from Coma recovery scale-revised（CRS-R）
timeFrame: Assessment within 24 hours before, and 1 hour after TMS treatment
measure: Change from the p300 in electroencephalogram
timeFrame: Assessment within 24 hours before, and 1 hour after TMS treatment
measure: Change from resting-state in electroencephalogram
timeFrame: Assessment within 24 hours before, and 1 hour after TMS treatment
measure: Change from TEP in electroencephalogram
timeFrame: Assessment within 24 hours before, and 1 hour after TMS treatment
measure: Change from PCI in electroencephalogram
timeFrame: Assessment within 24 hours before, and 1 hour after TMS treatment
measure: Change from ROI in neuroimage techniques-PET
timeFrame: Assessment within 24 hours before ,and 1 hour after TMS treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu hospitial, capical medical university
Study officials:
References: