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Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466554
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Shay Efrati, Assaf-Harofeh Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Ptsd Device: Hyperbaric oxygen-90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder
Actual Study Start Date : March 4, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Hyperbaric oxygen-90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes
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.

No Intervention: 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).




Primary Outcome Measures :
  1. Change in PTSD symptoms [ Time Frame: at baseline and after 3 months ]
    Symptoms assessed by the PTSD questionnaire (0-80)


Secondary Outcome Measures :
  1. Change in Sleep disorders questionnaire [ Time Frame: at baseline and after 3 months ]
    Medical Outcome Sleep Scale (MOS) (0-100) higher values represent a better outcome

  2. Change in Cognitive function [ Time Frame: at baseline and after 3 months ]
    mainstreams Cognitive Health Assessment (values normalized for age and gender, with mean value of 100 and standard deviation of 15)

  3. Change in Brain imaging [ Time Frame: at baseline and after 3 months ]
    Brain imaging will include 2 types of imaging: perfusion magnetic resonance imaging (MRI) + diffusion tensor imaging (DTI), including resting state functional MRI and brain single photon emission computed tomography (PET-CT).

  4. change in symptoms assessed by Diary for daily documentation of symptoms [ Time Frame: at baseline and after 3 months ]
    VAS based mood score higher values represent a worse outcome

  5. Change in Physiological evaluation of brain functionality [ Time Frame: at baseline and after 3 months ]
    This examination includes non-invasive safe brain monitoring and stimulation for the assessment of changes in brain functionality and connectivity. The procedure includes placement of EEG electrodes on an individual's head and measurement of the TMS-evoked electrophysiological response in the various brain regions.



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466554


Locations
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Israel
Assaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
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Responsible Party: Prof. Shay Efrati, head of segol center, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03466554    
Other Study ID Numbers: 199-17
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders