Hyperbaric Oxygen Therapy vs. Cognitive Training for Fetal Alcohol Spectrum Disorder; A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Cognitive health assessment (NeuroTrax)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive training
Neuropsychologist guided cognitive training.
干预措施: Cognitive training (Behavioral)
结局指标
主要结局
Cognitive health assessment (NeuroTrax)
时间窗: 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
时间窗: baseline, 3 months
Evaluated using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-reported questionnaire
次要结局
- Brain microstructure - (FA)(baseline, 3 months)
- Brain perfusion(baseline, 3 months)
- Brain microstructure - (MD)(baseline, 3 months)
- Difficulties in Emotion Regulation Scale (DERS)(baseline, 3 months, 6 months)
- Mental Health Continuum (MHC-SF)(baseline, 3 months, 6 months)
- Brain function imaging(baseline, 3 months)
- Metabolic Brain function imaging(baseline, 3 months)
- Depression anxiety and stress(baseline, 3 months, 6 months)
- Interpersonal Reactive Index (IRI)(baseline, 3 months, 6 months)