Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The study evaluates the effect of hyperbaric oxygen therapy on veterans with
      combat-associated PTSD in an double blind sham control study.
    

Detailed description: 
      Post-traumatic stress disorder (PTSD) is the brain's long-term imprint of a traumatic event.
      PTSD is characterized by intrusive thoughts, nightmares and flashbacks of past traumatic
      events, avoidance of trauma reminders, hypervigilance, and sleep disturbance, all of which
      lead to considerable social, occupational, and interpersonal dysfunction. The current
      available treatments for PTSD include medications and psychotherapy. However, a substantial
      proportion of patients have treatment resistant PTSD.

      In recent years there is growing evidence that traumatic events can induce changes in the
      brain's structure and function that may persist months or even years after the acute event.
      The "non-healing brain wound" can be visualized using functional imaging. The new insight
      regarding the biological nature of PTSD obligates biological intervention that can induce
      neuroplasticity and recovery of the damage brain tissue.

      Hyperbaric Oxygen Therapy (HBOT) includes the inhalation of 100% oxygen in a pressurized
      chamber with pressures exceeding 1 atmosphere absolute (ATA), thus enhancing the amount of
      oxygen dissolved in the body's tissues. It is now understood that the combined action of both
      hyperoxia and hyperbaric pressure together with, oxygen fluctuations generated by a
      pre-defined protocol may target both oxygen and pressure sensitive genes, resulting in
      improved mitochondrial metabolism with anti-apoptotic and anti-inflammatory effects.
      Moreover, these genes induce the proliferation of stem cells, augmented circulating levels of
      endothelial progenitor cells (EPCs) and angiogenesis factors, which induce angiogenesis and
      improved blood flow in the ischemic area. In recent years there is growing evidence that HBOT
      induced brain neuroplasticity leads to repair of chronically impaired brain functions in
      post-stroke and in traumatic brain injury (TBI) patients with prolonged post-concussion
      syndrome, even years after the brain insult, as well as in healthy aging adults. HBOT can
      also induce neuroplasticity and significantly improve the clinical symptoms of the most
      common prototype of central sensitization syndrome - fibromyalgia syndrome.

      The effects of HBOT on patients suffering from chronic unremitting PTSD due to combat trauma
      were evaluated in a pilot study done in the investigator's institute. The recently done study
      included veterans with combat associated PTSD according to the Ministry of Defense (MOD)
      criteria, who failed to improve using the current available treatments. The results of the
      study demonstrated the beneficial effect of HBOT in this unfortunate severely injured
      unremitting PTSD population. Clinically significant improvement was demonstrated in a major
      fraction of study participants. In correlation with the clinical improvement, a significant
      improvement in brain activity was demonstrated in the functional MRI imaging.

      The aim of the current study is to evaluate the effect of HBOT on chronic unremitting combat
      associated PTSD in an double blind sham control study
    

Intervention name(s): hyperbaric oxygen therapy
Intervention type(s): Device
Intervention description(s): The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes.
Investigational product:
Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sago l Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.1ATA, 21% oxygen)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyperbaric oxygen therapy