Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD
NCT ID: NCT04664790
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-10-20
2026-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Hyperbaric Oxygen
60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week.
Hyperbaric Oxygen
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Cognitive training
Neuropsychologist guided cognitive training.
Cognitive training
Neuropsychologist guided BrainHQ training
Interventions
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Hyperbaric Oxygen
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Cognitive training
Neuropsychologist guided BrainHQ training
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Shai a Efrati, MD
Role: PRINCIPAL_INVESTIGATOR
Asaf-Harofhe MC
Locations
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Assaf-Harofeh Medical Center
Ẕerifin, , Israel
Countries
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Central Contacts
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References
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Goodlett CR, Horn KH. Mechanisms of alcohol-induced damage to the developing nervous system. Alcohol Res Health. 2001;25(3):175-84.
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.
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.
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.
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.
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.
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.
Other Identifiers
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275-20-ASF
Identifier Type: -
Identifier Source: org_study_id
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