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PI died and thus study was terminated before recruiting
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen | Active Comparator | 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. |
|
| Cognitive training | Active Comparator | Neuropsychologist guided cognitive training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen | Device | Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brain perfusion | Cerebral blood volume and flow will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC). | baseline, 3 months |
| Brain microstructure - (MD) | Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shai a Efrati, MD | Asaf-Harofhe MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf-Harofeh Medical Center | Ẕerifin | Israel | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11810955 | Background | Goodlett CR, Horn KH. Mechanisms of alcohol-induced damage to the developing nervous system. Alcohol Res Health. 2001;25(3):175-84. | |
| 24471697 | Background | 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. |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D000066530 | Neurological Rehabilitation |
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| Cognitive training | Behavioral | Neuropsychologist guided BrainHQ training |
|
| baseline, 3 months |
| Brain microstructure - (FA) | Fractional anisotropy (FA) will be evaluated using diffusion tensor imaging (DTI) MRI protocol. | baseline, 3 months |
| Brain function imaging | Resting state fMRI (rsfMRI), and task based fmri will evaluate brain function during a working memory task. | baseline, 3 months |
| Metabolic Brain function imaging | Brain Single photon emission computed tomography (SPECT) will be conducted using Tc-99m-ECD. | baseline, 3 months |
| Depression anxiety and stress | Evaluated using the Depression Anxiety Stress Scale Test (DASS 21) self-report instrument. | baseline, 3 months, 6 months |
| Interpersonal Reactive Index (IRI) | 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) | The DERS questionnaire is a multidimensional self-report measure of emotion regulation | 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. | baseline, 3 months, 6 months |
| 23335971 | Background | 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. |
| 30618929 | Background | 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. |
| 31985478 | Background | 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. |
| 16166387 | Background | 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. |
| 30801636 | Background | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |