WithdrawnNot Applicable

Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD

Stopped: PI died and thus study was terminated before recruiting

Israel0Started 2021-10-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive health assessment (NeuroTrax)

Timeframe: baseline, 3 months

Executive functions and self-regulation in everyday environment

Timeframe: baseline, 3 months

Trial details

NCT IDNCT04664790

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More FASD trials