Clinical trial NCT06097013: Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness
Official title: Science and Technology Innovation 2030
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Disorder of Consciousness
Keywords: Brain Function Test
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Tianjin University
name: Jilin University
First posted: 2023-10-24
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prolonged disorders of consciousness and acute disorders of consciousness

Brief summary: The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

Detailed description: A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with acute and prolonged disorders of consciousness(DOC). 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;

Eligibility criteria: Admission criteria for patients with prolonged disorders of consciousness

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

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
timeFrame: Within 24 hours of enrollment
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
Secondary outcomes:
measure: Change from ROI in neuroimage techniques-PET
timeFrame: Assessment within 24 hours before ,and 1 hour after TMS treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu hospitial, capical medical university
Study officials:
References: