Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD
- Conditions
- FASD
- Interventions
- Behavioral: Cognitive trainingDevice: Hyperbaric Oxygen
- Registration Number
- NCT04664790
- Lead Sponsor
- Assaf-Harofeh Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cognitive training Cognitive training Neuropsychologist guided cognitive training. Hyperbaric Oxygen Hyperbaric Oxygen 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week.
- Primary Outcome Measures
Name Time Method Cognitive health assessment (NeuroTrax) 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 baseline, 3 months Evaluated using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-reported questionnaire
- Secondary Outcome Measures
Name Time Method Metabolic Brain function imaging baseline, 3 months Brain Single photon emission computed tomography (SPECT) will be conducted using Tc-99m-ECD.
Brain perfusion baseline, 3 months Cerebral blood volume and flow will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
Brain microstructure - (MD) baseline, 3 months Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol.
Brain microstructure - (FA) baseline, 3 months Fractional anisotropy (FA) will be evaluated using diffusion tensor imaging (DTI) MRI protocol.
Difficulties in Emotion Regulation Scale (DERS) baseline, 3 months, 6 months The DERS questionnaire is a multidimensional self-report measure of emotion regulation
Mental Health Continuum (MHC-SF) baseline, 3 months, 6 months 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.
Brain function imaging baseline, 3 months Resting state fMRI (rsfMRI), and task based fmri will evaluate brain function during a working memory task.
Depression anxiety and stress baseline, 3 months, 6 months Evaluated using the Depression Anxiety Stress Scale Test (DASS 21) self-report instrument.
Interpersonal Reactive Index (IRI) baseline, 3 months, 6 months The IRI questionnaire will be used to evaluate cognitive and affective aspects of empathic abilities.
Trial Locations
- Locations (1)
Assaf-Harofeh Medical Center
🇮🇱Zerifin, Israel