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NCT07855848
AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
Conditions: Disorders of Consciousness, Vegetative State, Minimally Conscious State
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Location: Shenzhen Baoxing Hospital Shenzhen Guangdong
Summary
Disorders of consciousness (DoC) are severe neurological conditions characterized by impaired awareness and reduced interaction with the environment. Although hyperbaric oxygen therapy (HBOT) may promote neurological recovery, the optimal treatment strategy for individual patients remains unclear.
This study aims to develop and validate an artificial intelligence-assisted precision decision support system for HBOT based on dynamic BIS-EEG brain functional feedback. The system will integrate clinical information, neuroimaging data, physiological parameters, consciousness assessments, and HBOT treatment characteristics.
Continuous BIS-EEG monitoring will be performed during different phases of HBOT, including compression, oxygen exposure, air breaks, decompression, and post-treatment recovery. Artificial intelligence models will analyze these dynamic brain functional responses to predict treatment effectiveness and support personalized HBOT management.
The primary outcome will be improvement in consciousness assessed by the Coma Recovery Scale-Revised (CRS-R). Secondary outcomes include changes in consciousness state, cognitive and functional recovery, and treatment-related adverse events.
Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18 years or older.
2. Diagnosis of disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS).
3. Disease duration of at least 28 days after the onset of brain injury.
4. Stable medical condition suitable for hyperbaric oxygen therapy.
5. Baseline consciousness assessment available using the Coma Recovery Scale-Revised (CRS-R).
6. Ability to undergo standardized hyperbaric oxygen therapy sessions and complete clinical follow-up.
7. Written informed consent obtained from the legally authorized representative.
Exclusion Criteria:
1. Contraindications to hyperbaric oxygen therapy, including untreated pneumothorax or other conditions considered unsafe for HBOT.
2. Severe cardiovascular, respiratory, or systemic instability.
3. Uncontrolled epilepsy or frequent seizures affecting assessment.
4. Severe infection or metabolic disorders that may influence consciousness assessment.
5. Previous participation in another interventional clinical trial that may affect neurological outcomes.
6. Incomplete baseline clinical data or inability to complete follow-up assessments.
Source: ClinicalTrials.gov (NCT07855848). StuddyBuddy aggregates publicly available trial information.