Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

— HBOT  

Official title:

Hyperbaric Oxygen Therapy for Chronic Unremitting Post-Traumatic Stress Disorder (PTSD): a Prospective, Randomized, Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518007
• Other study ID #: 291-19
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subject willing and able to read, understand and sign an informed consent
• Age 25-60
• Five years or more after the last traumatic exposure
• CAPS-5 score PTSD symptoms questionnaire = 20.
• Failure to improve after at least one line of conventional therapy, such as prolonged exposure, trauma related psychotherapy, eye movement desensitization therapy (EMDR).
• Stable psychological and pharmacological treatment for more than three months prior to inclusion.

Exclusion Criteria:

• Inability to attend scheduled clinic visits and/or comply with the study protocol.
• History of TBI or any other brain pathology
• Active malignancy
• Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
• Current manic episode or psychotic disorders
• Serious suicidal ideation
• Severe or unstable physical disorders or major cognitive deficits at baseline
• for any reason prior to study enrollment
• Chest pathology incompatible with pressure changes (including active asthma)
• Ear or Sinus pathology incompatible with pressure changes
• An inability to perform an awake brain MRI
• active smoking

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Israel	Dialysis Clinic in Asaf Harofhe Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms	PTSD symptoms will be assessed by the PTSD Clinician-Administered PTSD Scale (CAPS) questionnaire.	Change from Baseline immediately after the intervention
Secondary	depression	Beck depression inventory II	Change from Baseline immediately after the intervention
Secondary	Changes in growth following a traumatic event	The post-traumatic growth inventory (PTGI)	Change from Baseline immediately after the intervention
Secondary	wellbeing	Changes will be measured by the wellbeing inventory (WBI).	Change from Baseline immediately after the intervention
Secondary	emotional regulation	Changes in emotional regulation will be measured by the emotion regulation questionnaire (ERQ).	Change from Baseline immediately after the intervention
Secondary	global distress	The brief symptom inventory (BSI)	Change from Baseline immediately after the intervention
Secondary	sleep quality	Changes in sleep patterns will be measured using the Pittsburgh sleep quality index (PSQI).	Change from Baseline immediately after the intervention
Secondary	Depression, anxiety and stress	Depression, anxiety and stress will be evaluated using scale-21 items (DASS-21)	Change from Baseline immediately after the intervention
Secondary	Daily documentation of symptoms	Daily distress and change in symptoms will be evaluated using visual assessment scale (VAS) based questionnaire	daily during intervention, up to 16 weeks
Secondary	Mind streams cognitive health assessment (Mind streams)	memory, attention and information process will be evaluated using the Mind streams cognitive health assessment (Mind streams)	Change from Baseline immediately after the intervention
Secondary	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.	Change from Baseline immediately after the intervention
Secondary	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	Change from Baseline immediately after the intervention
Secondary	Cardiopulmonary exercise test	The cardiopulmonary exercise test (CPET) is a noninvasive measurement of the cardiovascular system, respiratory system and muscles	Change from Baseline immediately after the intervention
Secondary	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	Change from Baseline immediately after the intervention