An interventional study of hyperbaric oxygen therapy in Post Traumatic Stress Disorder, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to male participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
The study evaluates the effect of hyperbaric oxygen therapy on veterans with combat-associated PTSD in an double blind sham control study.
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
2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.
This study's enrollment of 56 is below the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes.
Device: hyperbaric oxygen therapy
All the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, where the pressure will go up to 2 ATA, in the sham condition the pressure will go up to 1.1 ATA during the first five minutes of the session with noise of circulating air, and then decrease slowly during the next half hour to 1.0 ATA and the oxygen level will be 21% The initial 1.1 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects.
Device: hyperbaric oxygen therapy
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.
PTSD symptoms
PTSD symptoms will be assessed by the PTSD Clinician-Administered PTSD Scale (CAPS) questionnaire.
Time frame: Change from Baseline immediately after the intervention
depression
Beck depression inventory II
Time frame: Change from Baseline immediately after the intervention
Changes in growth following a traumatic event
The post-traumatic growth inventory (PTGI)
Time frame: Change from Baseline immediately after the intervention
wellbeing
Changes will be measured by the wellbeing inventory (WBI).
Time frame: Change from Baseline immediately after the intervention
emotional regulation
Changes in emotional regulation will be measured by the emotion regulation questionnaire (ERQ).
Time frame: Change from Baseline immediately after the intervention
global distress
The brief symptom inventory (BSI)
Time frame: Change from Baseline immediately after the intervention
sleep quality
Changes in sleep patterns will be measured using the Pittsburgh sleep quality index (PSQI).
Time frame: Change from Baseline immediately after the intervention
Depression, anxiety and stress
Depression, anxiety and stress will be evaluated using scale-21 items (DASS-21)
Time frame: Change from Baseline immediately after the intervention
Daily documentation of symptoms
Daily distress and change in symptoms will be evaluated using visual assessment scale (VAS) based questionnaire
Time frame: daily during intervention, up to 16 weeks
Mind streams cognitive health assessment (Mind streams)
memory, attention and information process will be evaluated using the Mind streams cognitive health assessment (Mind streams)
Time frame: Change from Baseline immediately after the intervention
MRI Imaging
At each of the evaluations, patients will undergo structural and functional MRI scanning. Images will be acquired on Vida 3 Tesla Scanner, configured with a 64-channel receiver head coils (Siemens Healthcare, Erlangen, Germany) at Shamir medical center radiology department.
Time frame: Change from Baseline immediately after the intervention
Brain SPECT
SPECT will be conducted with 925-1,110 (25-30 mCi) of technetium-99m-methyl-cysteinate-dimmer (Tc-99m-ECD) at 40-60 min post injection, using a dual detector gamma camera (Siemens Medical Systems) equipped with high resolution collimators
Time frame: Change from Baseline immediately after the intervention
Cardiopulmonary exercise test
The cardiopulmonary exercise test (CPET) is a noninvasive measurement of the cardiovascular system, respiratory system and muscles
Time frame: Change from Baseline immediately after the intervention
Immune system
Inflammatory cytokines: blood tests will include: interleukin (IL) IL-1, IL-6, tumor necrosis factor-alpha, C reactive protein and T cells panel
Time frame: Change from Baseline immediately after the intervention
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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