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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Assaf-Harofeh Medical Center

Ẕerifin, Israel, 70300