Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in PTSD symptoms
研究概览
简要总结
Posttraumatic stress disorder (PTSD) is the long term effect of severely distressing traumatic event characterized by intrusive thoughts, nightmares, and avoidance. Brain imaging of PTSD patients demonstrate alterations in regional brain perfusion, with stunned, hypoperfused regions. Those brain-biological pathologies may be responsible for the limited success rate of currently available interventions.
During the last years data regarding Hyperbaric Oxygen Therapy (HBOT) induced neuroplasticity accumulated. A number of studies in traumatic brain injury, cerebrovascular attacks, and fibromyalgia have presented evidence of improved perfusion and recovery of metabolic brain tissues, accompanied by clinical improvement under HBOT even years after the acute insults.
Considerable evidence supports potential benefit of HBOT on PTSD, however, no clinical trial was done on this pure PTSD population. The aim of the proposed study is to examine hyperbaric oxygen therapy as a treatment for PTSD. Advanced brain imaging and functional analysis tools will be used to evaluate treatment's effect.
详细描述
Posttraumatic stress disorder (PTSD) has been described as "the complex somatic, cognitive, affective, and behavioral effects of psychological trauma". PTSD is triggered by a severe distressing traumatic event, in which an overwhelming amount of stress exceeds the ability of the individual to cope or integrate the emotions involved in the experience. The fact that a large portion of the affected population is previously healthy, young people who were thrown off their life course, contribute to the great motivation for research in this field. But unfortunately, the current available treatment improve some of the symptoms in only 32-66% of patients, and even after treatment, up to 60% still meet PTSD diagnosis.
In the last few years, there is growing knowledge regarding the neuro-biological changes that characterize PTSD. Brain imaging demonstrates alterations in regional brain perfusion, with stunning, hypoperfused regions. Those enduring brain-biological pathologies may explain the limited success rate of currently available interventions.
Accumulating studies presents evidence that hyperbaric oxygen therapy (HBOT) can induce neuroplasticity and recovery of metabolic injured brain tissues, even years after the acute insults. HBOT can initiate several brain-repair related mechanisms including brain angiogenesis; improve cerebral vascular flow enable regeneration of axonal white matter, stimulate axonal growth, promote blood-brain barrier integrity and reduce inflammatory reactions, as well as in brain edema.
The potential beneficial effects of HBOT were demonstrated in several clinical trials of traumatic brain injury(TBI)/post-concussion patients. Some of these trials, especially those in veterans, included patients who, in addition to post-concussion syndrome, had PTSD; as it is estimated that half of the soldiers with post-concussion syndrome due to mild TBI also meet the criteria of PTSD.
The aim of the proposed study is to evaluate the effect of HBOT on PTSD symptoms in adults with treatment resistant PTSD who were not exposed to TBI or blast injury. In addition to the clinical outcome, brain functionality and microstructure will also be evaluated by PET and DTI-MRI in order to shed additional light on the pathophysiology of PTSD and its response to treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult onset PTSD, defined by DSM-V criteria, as a result of combat or a terror- related event.
- •Age 25-60 years, 4-years or more from the traumatic event and failure to improve with at least one line of conventional treatment.
排除标准
- •A history of traumatic brain injury, epilepsy, a brain tumor; skull base fractures or neurosurgery.
- •Severe substance use disorders a current manic episode, psychotic disorders or serious suicidal ideation at baseline.
- •Major cognitive deficits
- •History of HBOT for any reason, prior to study enrollment.
- •Chest pathology incompatible with pressure changes (including active asthma).
- •Inner ear disease.
- •The inability to perform an awake brain MRI test.
- •Inability to provide informed consent
研究组 & 干预措施
hyperbaric oxygen therapy (HBOT) active treatment
60 daily HBOT sessions will be administrated 5 days per week. Comprise of 90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes.
干预措施: Hyperbaric oxygen-90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes (Device)
Control-follow up
The standard of care of psychological and mediational support .
After 3 months of follow up, participants will be re-evaluated. The individuals in the control group will then be offered to receive the treatment and to be re-reevaluated after the treatment is over (3 months).
结局指标
主要结局
Change in PTSD symptoms
时间窗: at baseline and after 3 months
Symptoms assessed by the PTSD questionnaire (0-80)
次要结局
- Change in Brain imaging(at baseline and after 3 months)
- Change in Cognitive function(at baseline and after 3 months)
- change in symptoms assessed by Diary for daily documentation of symptoms(at baseline and after 3 months)
- Change in Sleep disorders questionnaire(at baseline and after 3 months)
- Change in Physiological evaluation of brain functionality(at baseline and after 3 months)
研究者
Shay Efrati
head of segol center
Assaf-Harofeh Medical Center