Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD

Shamir Medical Center (Assaf-Harofeh)

Status: Not yet enrolling

Conditions: FASD

Treatments: Behavioral: Cognitive training; Device: Hyperbaric Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04664790

275-20-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Hyperbaric Oxygen

Active Comparator group

Description:

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

Treatment:

Device: Hyperbaric Oxygen

Cognitive training

Active Comparator group

Description:

Neuropsychologist guided cognitive training.

Treatment:

Behavioral: Cognitive training