Consciousness Disorder Clinical Trial
Official title:
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness Based on Electroencephalogram and Event-related Potential
Verified date | June 2023 |
Source | Beijing Tiantan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness based on Electroencephalography and Auditory Event-related Potentials
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 1, 2026 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18 - 65 years old, native Chinese speaker, dextromanuality; - Chronic disorder of consciousness; - Spinal cord electrical stimulator implantation under general anesthesia; - Signed informed consent. Exclusion Criteria: - Continuous sedation was administered within 72 hours prior to the study; - Open head injury, parenchymatectomy and other damage of brain structural integrity; - The intracranial compliance decreased due to hydrocephalus and swelling; - Known hearing impairment; - Airway stenosis and various causes of severe ventilation or ventilation dysfunction; - Known or suspected cardiac dysfunction; - Allergic to intravenous general anesthetics; - Associated with other mental or neurological diseases; - Other reasons are not suitable to participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital, Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EEG Spectral Characteristics | Characteristics of EEG power spectrum(for 1-30 Hz) in patients with chronic consciousness disorder under different doses of drugs | During the trial(up to 3 hours for each subject) | |
Secondary | Cortical Connectivity | Characteristics of the weighted phase lag index in patients with chronic consciousness | During the trial(up to 3 hours for each subject) | |
Secondary | Derived quantitative indicators | Characteristics of EEG derived quantitative indicators with chronic consciousness disorder during anesthesia recovery | During the trial(up to 3 hours for each subject) | |
Secondary | Characteristics of sleep | Characteristics of sleep cycle in patients with chronic disorders of consciousness | During the trial(up to 24 hours for each subject) | |
Secondary | Dynamic Patterns of Cortical Connectivity | The time-frequency characteristics of the weighted phase lag index in patients with chronic disorders of consciousness | During the trial(up to 3 hours for each subject) | |
Secondary | Rate of patients recovered consciousness after surgery | Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery | During the trial(through study completion, 180 days) |
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