Status:
NOT_YET_RECRUITING
Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
FASD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fetal Alcohol Spectrum Disorder (FASD) describes a wide range of adverse physical, behavioral and cognitive effects resulting from prenatal alcohol exposure (PAE) during embryonic and fetal developmen...
Detailed Description
Fetal Alcohol Spectrum Disorder (FASD) describes a wide range of adverse physical, behavioral and cognitive effects resulting from prenatal alcohol exposure (PAE) during embryonic and fetal developmen...
Eligibility Criteria
Inclusion
- Subject willing and able to sign an informed consent
- Age 18 years and older
- Diagnosed with FASD by an Israeli expert
- Failure to improve after at least one line of conventional therapy
- Stable psychological and pharmacological treatment for over three months prior to inclusion
Exclusion
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- History of other brain pathologies
- Active malignancy
- Serious suicidal ideation
- Severe or unstable physical disorders at baseline
- History of HBOT for any reason prior to study enrollment
- Chest pathology incompatible with pressure changes (including active asthma)
- Inner ear disease
- Contraindications for MRI or inability to perform an awake brain MRI
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04664790
Start Date
October 20 2025
End Date
January 1 2026
Last Update
July 3 2024
Active Locations (1)
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1
Assaf-Harofeh Medical Center
Ẕerifin, Israel, 70300