AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness (AI-HBOT-DoC)
A Randomized Controlled Trial of Artificial Intelligence-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback in Patients With Disorders of Consciousness
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.
Přehled studie
Postavení
Detailní popis
This prospective randomized controlled clinical study will evaluate whether an artificial intelligence-assisted precision hyperbaric oxygen therapy strategy improves clinical outcomes compared with conventional hyperbaric oxygen therapy in patients with disorders of consciousness.
Patients with disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome and minimally conscious state, will receive standardized hyperbaric oxygen therapy. Multimodal clinical data will be collected, including demographic characteristics, disease etiology, disease duration, baseline consciousness assessment, neuroimaging findings, physiological parameters, BIS-EEG signals, and HBOT treatment parameters.
Dynamic BIS-EEG monitoring will be conducted throughout the entire HBOT session. Brain functional responses will be evaluated during the following phases: pre-treatment baseline, compression, hyperbaric oxygen exposure, air-break interval, repeated oxygen exposure, decompression, and post-treatment recovery.
The artificial intelligence system will integrate multimodal information using machine learning approaches to identify predictive biomarkers of neurological recovery and provide individualized decision support regarding HBOT treatment parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course.
The effectiveness of the AI-assisted decision support system will be evaluated by comparing predicted treatment responses with clinical outcomes. Clinical outcomes will include changes in Coma Recovery Scale-Revised (CRS-R) scores, consciousness state transitions, cognitive and functional recovery, and adverse events associated with HBOT.
This study is expected to provide an objective and personalized approach for optimizing HBOT management in patients with disorders of consciousness.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Anmin Hu Shenzhen United Scheme Technology Co., Ltd.
- Telefonní číslo: +86 17318061949
- E-mail: anmin@szus.org
Studijní záloha kontaktů
- Jméno: Xiaofeng Chen Shenzhen Baoxing Hospital
Studijní místa
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Guangdong
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Shenzhen, Guangdong, Čína, 518020
- Shenzhen Baoxing Hospital
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Kontakt:
- Xiaofeng Chen Shenzhen Baoxing Hospital
- Telefonní číslo: 0755-28746265
- E-mail: us@szus.org
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Adults aged 18 years or older.
- Diagnosis of disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS).
- Disease duration of at least 28 days after the onset of brain injury.
- Stable medical condition suitable for hyperbaric oxygen therapy.
- Baseline consciousness assessment available using the Coma Recovery Scale-Revised (CRS-R).
- Ability to undergo standardized hyperbaric oxygen therapy sessions and complete clinical follow-up.
- Written informed consent obtained from the legally authorized representative.
Exclusion Criteria:
- Contraindications to hyperbaric oxygen therapy, including untreated pneumothorax or other conditions considered unsafe for HBOT.
- Severe cardiovascular, respiratory, or systemic instability.
- Uncontrolled epilepsy or frequent seizures affecting assessment.
- Severe infection or metabolic disorders that may influence consciousness assessment.
- Previous participation in another interventional clinical trial that may affect neurological outcomes.
- Incomplete baseline clinical data or inability to complete follow-up assessments.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: AI-Assisted Personalized Hyperbaric Oxygen Therapy
Participants will receive artificial intelligence-assisted precision hyperbaric oxygen therapy. The AI decision support system will integrate dynamic BIS-EEG brain functional feedback, clinical characteristics, neuroimaging findings, physiological parameters, and previous treatment responses to provide individualized recommendations for hyperbaric oxygen therapy parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course. |
Participants will receive hyperbaric oxygen therapy optimized by an artificial intelligence-assisted clinical decision support system. The system integrates dynamic BIS-EEG brain functional feedback, clinical characteristics, neuroimaging findings, physiological parameters, and previous treatment responses to provide individualized recommendations for hyperbaric oxygen therapy parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course. Final treatment decisions will be made by qualified physicians. |
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Aktivní komparátor: Conventional Hyperbaric Oxygen Therapy
Participants will receive conventional hyperbaric oxygen therapy according to standard clinical protocols determined by treating physicians. Treatment parameters will be selected based on routine clinical practice without artificial intelligence-assisted recommendations. |
Participants will receive conventional hyperbaric oxygen therapy according to standard clinical protocols determined by treating physicians. Treatment parameters will be selected based on routine clinical practice without artificial intelligence-assisted recommendations. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Coma Recovery Scale-Revised (CRS-R) Total Score at Week 12
Časové okno: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
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The Coma Recovery Scale-Revised (CRS-R) will be used to assess the level of consciousness. The CRS-R total score ranges from 0 to 23, with higher scores indicating better neurobehavioral function and a higher level of consciousness. The change in CRS-R total score from baseline to Week 12 will be calculated for each participant and compared between the AI-assisted precision hyperbaric oxygen therapy group and the conventional hyperbaric oxygen therapy group. |
Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Glasgow Coma Scale (GCS) Total Score at Week 12
Časové okno: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
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The Glasgow Coma Scale (GCS) will be used to assess neurological responsiveness. The total score ranges from 3 to 15, with higher scores indicating better neurological responsiveness. Change from baseline to Week 12 will be compared between the AI-assisted precision hyperbaric oxygen therapy group and the conventional hyperbaric oxygen therapy group. |
Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
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Number of Participants With Hyperbaric Oxygen Therapy-Related Adverse Events
Časové okno: From the first hyperbaric oxygen therapy session through 7 days after the final treatment session
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The number and proportion of participants experiencing adverse events considered related to hyperbaric oxygen therapy will be recorded and compared between groups. Events of interest include middle-ear or sinus barotrauma, oxygen toxicity, seizures, pulmonary symptoms, hemodynamic instability, and other clinically significant treatment-related adverse events. |
From the first hyperbaric oxygen therapy session through 7 days after the final treatment session
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Discrimination Performance of the AI Model for Predicting Improvement in Consciousness State
Časové okno: Prediction at baseline and during treatment for clinical outcome assessed at Week 12
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The predictive performance of the artificial intelligence model will be evaluated for predicting improvement to a higher consciousness state at Week 12. Discrimination will be assessed using the area under the receiver operating characteristic curve (AUROC). An AUROC of 0.5 indicates no discrimination, whereas values closer to 1.0 indicate better discrimination. |
Prediction at baseline and during treatment for clinical outcome assessed at Week 12
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Duševní poruchy
- Neurobehaviorální projevy
- Neurokognitivní poruchy
- Poškození mozku, chronické
- Bezvědomí
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Poruchy vědomí
- Trvalý vegetativní stav
Další identifikační čísla studie
- WINDO-CT-26001
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