Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder (NCT03466554) | Clinical Trial Compass
CompletedNot Applicable
Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder
Israel30 participantsStarted 2018-03-04
Plain-language summary
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.
Who can participate
Age range
25 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.