FASDNCT04664790
Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD
A study testing Hyperbaric Oxygen and Cognitive training in people with FASD, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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 development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FASD
- What is being tested?
- Hyperbaric Oxygen and Cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Oct 2021to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chest pathology incompatible with pressure changes (including active asthma)
- Inner ear disease
- Contraindications for MRI or inability to perform an awake brain MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- FASD
- Being tested
- Hyperbaric Oxygen, Cognitive training
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenDevice
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Cognitive trainingBehavioural
Neuropsychologist guided BrainHQ training
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen | Active comparator | 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Receives: Device: Hyperbaric Oxygen |
| Cognitive training | Active comparator | Neuropsychologist guided cognitive training. Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive health assessment (NeuroTrax)
Memory, attention and information process will be evaluated using the NeuroTrax computerized cognitive evaluation battery.
Measured: baseline, 3 months
Executive functions and self-regulation in everyday environment
Evaluated using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-reported questionnaire
Measured: baseline, 3 months
Secondary outcomes (9)
Brain perfusion
Cerebral blood volume and flow will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
Measured: baseline, 3 months
Brain microstructure - (MD)
Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol.
Measured: baseline, 3 months
Brain microstructure - (FA)
Fractional anisotropy (FA) will be evaluated using diffusion tensor imaging (DTI) MRI protocol.
Measured: baseline, 3 months
Brain function imaging
Resting state fMRI (rsfMRI), and task based fmri will evaluate brain function during a working memory task.
Measured: baseline, 3 months
Metabolic Brain function imaging
Brain Single photon emission computed tomography (SPECT) will be conducted using Tc-99m-ECD.
Measured: baseline, 3 months
Depression anxiety and stress
Evaluated using the Depression Anxiety Stress Scale Test (DASS 21) self-report instrument.
Measured: baseline, 3 months, 6 months
Interpersonal Reactive Index (IRI)
The IRI questionnaire will be used to evaluate cognitive and affective aspects of empathic abilities.
Measured: baseline, 3 months, 6 months
Difficulties in Emotion Regulation Scale (DERS)
The DERS questionnaire is a multidimensional self-report measure of emotion regulation
Measured: baseline, 3 months, 6 months
Mental Health Continuum (MHC-SF)
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.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start20 Oct 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Why it stopped: PI died and thus study was terminated before recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664790
- Sponsor's protocol ID
- 0275-20-ASF
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2020
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goodlett CR, Horn KH. Mechanisms of alcohol-induced damage to the developing nervous system. Alcohol Res Health. 2001;25(3):175-84.
PubMed 11810955Efrati S, Ben-Jacob E. Reflections on the neurotherapeutic effects of hyperbaric oxygen. Expert Rev Neurother. 2014 Mar;14(3):233-6. doi: 10.1586/14737175.2014.884928. Epub 2014 Jan 29.
PubMed 24471697Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15.
PubMed 23335971Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018.
PubMed 30618929Hadanny A, Rittblat M, Bitterman M, May-Raz I, Suzin G, Boussi-Gross R, Zemel Y, Bechor Y, Catalogna M, Efrati S. Hyperbaric oxygen therapy improves neurocognitive functions of post-stroke patients - a retrospective analysis. Restor Neurol Neurosci. 2020;38(1):93-107. doi: 10.3233/RNN-190959.
PubMed 31985478Stoller KP. Quantification of neurocognitive changes before, during, and after hyperbaric oxygen therapy in a case of fetal alcohol syndrome. Pediatrics. 2005 Oct;116(4):e586-91. doi: 10.1542/peds.2004-2851. Epub 2005 Sep 15.
PubMed 16166387Koren G, Golan C, Suzin G, Berkovich M, Efrati S. Effects of Hyperbaric Oxygen Therapy on Brain Perfusion, Cognition and Behavior in Fetal Alcohol Spectrum Disorder-A Case Study. Alcohol Alcohol. 2019 Mar 1;54(2):177-179. doi: 10.1093/alcalc/agz009.
PubMed 30801636
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy vs. Cognitive Training for Fetal Alcohol Spectrum Disorder; A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04664790
- Acronym / sponsor ID
- 0275-20-ASF
- Conditions
- FASD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI died and thus study was terminated before recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen | Active comparator | Device: Hyperbaric Oxygen60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. |
| Cognitive training | Active comparator | Behavioral: Cognitive trainingNeuropsychologist guided cognitive training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric OxygenEach session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes | Device | Hyperbaric Oxygen |
| Cognitive trainingNeuropsychologist guided BrainHQ training | Behavioural | Cognitive training |
Primary outcome
Cognitive health assessment (NeuroTrax)
Time frame: baseline, 3 months
Memory, attention and information process will be evaluated using the NeuroTrax computerized cognitive evaluation battery.
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
9 secondary outcomes
Brain perfusion
Time frame: baseline, 3 months
Brain microstructure - (MD)
Time frame: baseline, 3 months
Brain microstructure - (FA)
Time frame: baseline, 3 months
Brain function imaging
Time frame: baseline, 3 months
Metabolic Brain function imaging
Time frame: baseline, 3 months
Depression anxiety and stress
Time frame: baseline, 3 months, 6 months
Interpersonal Reactive Index (IRI)
Time frame: baseline, 3 months, 6 months
Difficulties in Emotion Regulation Scale (DERS)
Time frame: baseline, 3 months, 6 months
Mental Health Continuum (MHC-SF)
Time frame: baseline, 3 months, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 11810955Goodlett CR, Horn KH. Mechanisms of alcohol-induced damage to the developing nervous system. Alcohol Res Health. 2001;25(3):175-84.
- Background: PubMed 24471697Efrati S, Ben-Jacob E. Reflections on the neurotherapeutic effects of hyperbaric oxygen. Expert Rev Neurother. 2014 Mar;14(3):233-6. doi: 10.1586/14737175.2014.884928. Epub 2014 Jan 29.
- Background: PubMed 23335971Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15.
- Background: PubMed 30618929Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018.
- Background: PubMed 31985478Hadanny A, Rittblat M, Bitterman M, May-Raz I, Suzin G, Boussi-Gross R, Zemel Y, Bechor Y, Catalogna M, Efrati S. Hyperbaric oxygen therapy improves neurocognitive functions of post-stroke patients - a retrospective analysis. Restor Neurol Neurosci. 2020;38(1):93-107. doi: 10.3233/RNN-190959.
- Background: PubMed 16166387Stoller KP. Quantification of neurocognitive changes before, during, and after hyperbaric oxygen therapy in a case of fetal alcohol syndrome. Pediatrics. 2005 Oct;116(4):e586-91. doi: 10.1542/peds.2004-2851. Epub 2005 Sep 15.
- Background: PubMed 30801636Koren G, Golan C, Suzin G, Berkovich M, Efrati S. Effects of Hyperbaric Oxygen Therapy on Brain Perfusion, Cognition and Behavior in Fetal Alcohol Spectrum Disorder-A Case Study. Alcohol Alcohol. 2019 Mar 1;54(2):177-179. doi: 10.1093/alcalc/agz009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen and Cognitive training in people with FASD, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive health assessment (NeuroTrax) (time frame: baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664790, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.