Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD

May 11, 2026 updated by: Assaf-Harofeh Medical Center

Hyperbaric Oxygen Therapy vs. Cognitive Training for Fetal Alcohol Spectrum Disorder; A Prospective, Randomized Clinical Trial

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 development. A number of clinical studies have presented evidence regarding the physiological effects of HBOT on metabolically dysfunctional brain regions that might be related to FASD. The aim of the study is to compare the effect of HBOT vs. neurocognitive training on neurobehavioral function in FASD.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 development. Currently individuals afflicted by FASD are treated symptomatically for ADHD and different forms of disruptive behavior. However, these approaches have not succeeded in improving the long-term clinical outcome [1].

A number of clinical studies have presented evidence regarding the physiological effects of hyperbaric oxygen therapy (HBOT) on metabolically dysfunctional brain regions that might be related to FASD [2-5]. Case studies conducted using HBOT suggested a potential safe and efficient treatment for FESD [6-7]. The aim of the study is to compare the effect of HBOT vs. neurocognitive training on neurobehavioral function in FASD.

The study is designed as a prospective randomized, two active arm trial. After enrolment, eligible participants will be randomized with equal probability into one of two arms: HBOT or cognitive training arm. The evaluation procedure will be performed twice, at baseline and 1-3 weeks after the last treatment session, and includes cognitive tests, FASD relegated questionnaires, and anatomical and functional brain imaging (MRI and SPECT). The study is designed as an intention to treat trial, and thus, patients will be included in the analysis if they completed at least one HBOT/cognitive training session, and attained post treatment study analysis.

The HBOT protocol will be administrated in a multi-place chamber. The protocol comprised of 60 daily sessions, 5 sessions per week within a three month period. Each session includes breathing 100% oxygen by mask at 2ATA for 90 minutes with 5-minute air breaks every 20 minutes.

The cognitive training protocol contains a neuropsychologist guided BrainHQ training program. This is a 3 months program that includes 30 minutes sessions at least 3 times per week.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Israel
      • Ẕerifin, Israel, Israel, 70300
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyperbaric Oxygen
60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week.
Device: Hyperbaric Oxygen
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Active Comparator: Cognitive training
Neuropsychologist guided cognitive training.
Behavioral: Cognitive training
Neuropsychologist guided BrainHQ training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive health assessment (NeuroTrax)
Time Frame: baseline, 3 months
Memory, attention and information process will be evaluated using the NeuroTrax computerized cognitive evaluation battery.
baseline, 3 months
Executive functions and self-regulation in everyday environment
Time Frame: baseline, 3 months
Evaluated using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-reported questionnaire
baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain perfusion
Time Frame: baseline, 3 months
Cerebral blood volume and flow will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
baseline, 3 months
Brain function imaging
Time Frame: baseline, 3 months
Resting state fMRI (rsfMRI), and task based fmri will evaluate brain function during a working memory task.
baseline, 3 months
Metabolic Brain function imaging
Time Frame: baseline, 3 months
Brain Single photon emission computed tomography (SPECT) will be conducted using Tc-99m-ECD.
baseline, 3 months
Depression anxiety and stress
Time Frame: baseline, 3 months, 6 months
Evaluated using the Depression Anxiety Stress Scale Test (DASS 21) self-report instrument.
baseline, 3 months, 6 months
Interpersonal Reactive Index (IRI)
Time Frame: baseline, 3 months, 6 months
The IRI questionnaire will be used to evaluate cognitive and affective aspects of empathic abilities.
baseline, 3 months, 6 months
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: baseline, 3 months, 6 months
The DERS questionnaire is a multidimensional self-report measure of emotion regulation
baseline, 3 months, 6 months
Mental Health Continuum (MHC-SF)
Time Frame: baseline, 3 months, 6 months
The MHC-SF questionnaire will be used to assess three components of well-being: emotional, social, and psychological and conduct categorical diagnosis of positive mental health.
baseline, 3 months, 6 months
Brain microstructure - (MD)
Time Frame: baseline, 3 months
Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol.
baseline, 3 months
Brain microstructure - (FA)
Time Frame: baseline, 3 months
Fractional anisotropy (FA) will be evaluated using diffusion tensor imaging (DTI) MRI protocol.
baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Shai a Efrati, MD, Asaf-Harofhe MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0275-20-ASF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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