NCT04664790

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
4.9 years until next milestone

Study Start

First participant enrolled

October 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

November 24, 2020

Last Update Submit

July 2, 2024

Conditions

FASD

Outcome Measures

Primary Outcomes (2)

  • Cognitive health assessment (NeuroTrax)

    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

    Evaluated using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-reported questionnaire

    baseline, 3 months

Secondary Outcomes (9)

  • Brain perfusion

    baseline, 3 months

  • Brain microstructure - (MD)

    baseline, 3 months

  • Brain microstructure - (FA)

    baseline, 3 months

  • Brain function imaging

    baseline, 3 months

  • Metabolic Brain function imaging

    baseline, 3 months

  • +4 more secondary outcomes

Study Arms (2)

Hyperbaric Oxygen

ACTIVE COMPARATOR

60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week.

Device: Hyperbaric Oxygen

Cognitive training

ACTIVE COMPARATOR

Neuropsychologist guided cognitive training.

Behavioral: Cognitive training

Interventions

Hyperbaric OxygenDEVICE

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

Hyperbaric Oxygen
Cognitive trainingBEHAVIORAL

Neuropsychologist guided BrainHQ training

Cognitive training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (7)

  • Goodlett CR, Horn KH. Mechanisms of alcohol-induced damage to the developing nervous system. Alcohol Res Health. 2001;25(3):175-84.

    PMID: 11810955BACKGROUND

  • Efrati 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.

    PMID: 24471697BACKGROUND

  • Efrati 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.

    PMID: 23335971BACKGROUND

  • Hadanny 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.

    PMID: 30618929BACKGROUND

  • Hadanny 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.

    PMID: 31985478BACKGROUND

  • Stoller 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.

    PMID: 16166387BACKGROUND

  • Koren 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.

    PMID: 30801636BACKGROUND

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Hyperbaric OxygenationCognitive Training

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeuticsNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Shai a Efrati, MD

    Asaf-Harofhe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai Efrati, Prof

CONTACT

97289779393efratishai@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 11, 2020

Study Start

October 20, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

IL(1)