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

NCT ID: NCT06097013

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2026-11-30

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;

Conditions

Disorder of Consciousness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prolonged disorders of consciousness

Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria

Routine clinical rehabilitation

Intervention Type: OTHER

Routine clinical rehabilitation

Acute disorders of consciousness

Admission criteria for patients with acute disorders of consciousness Inclusion Criteria

Routine clinical rehabilitation

Intervention Type: OTHER

Routine clinical rehabilitation

Interventions

Routine clinical rehabilitation

Routine clinical rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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;

(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

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;

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin University

OTHER

Sponsor Role: collaborator

Jilin University

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuan Wu hospitial, capical medical university

Beijing, , China

Countries

China

Other Identifiers

2021ZD0204300

Identifier Type: -

Identifier Source: org_study_id