HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psychometric testing
研究概览
简要总结
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18-65 years old
- •One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
- •Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
- •Absence of intracranial neurosurgery post-TBI
- •Disability Rating Scale of 0-3
- •Negative Michigan Alcohol Screening Test (MAST)
- •Negative Drug Abuse Screening Test (DAST)
- •Negative urine toxicology screen for drugs of abuse
- •Negative pregnancy test in females
- •Otherwise good health
- •Less than 90% on the Percent Back to Normal Rating Scale
排除标准
- •Pulmonary disease that precludes HBOT
- •Unstable medical conditions that are contraindicated in HBOT
- •Severe confinement anxiety
- •Pregnancy
- •Other pre-TBI neurological diagnoses
- •Pre or post TBI history of substance abuse
- •Pre or post TBI history of alcoholism.
- •Participation in another experimental trial with active intervention.
- •High probability of inability to complete the experimental protocol.
- •Previous HBOT
- •History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
- •Past or current history of mental retardation (baseline FSIQ <
- •Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
研究组 & 干预措施
Hyperbaric oxygen therapy-TBI/PCS
Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT
干预措施: Low pressure hyperbaric oxygen therapy (Drug)
Hyperbaric Oxygen Therapy-PCS/PTSD
Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT
干预措施: Low pressure hyperbaric oxygen therapy (Drug)
结局指标
主要结局
Psychometric testing
时间窗: 30 days
次要结局
- Quality of life measurements(30 days)
- Return to school or work(6 months)
- SPECT brain imaging(30 days)
研究者
Paul G. Harch, M.D.
Clinical Professor of Medicine
Louisiana State University Health Sciences Center in New Orleans