Enhanced Hippocampal Neuroplasticity for Surfacing of Inaccessible Traumatic Memories in Veterans With PTSD

NCT05883397 | Unknown

• 1 other identifier: 90-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperbaric oxygen therapy (HBOT) includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute. HBOT has been applied worldwide, mostly for chronic non-healing wounds. Our team demonstrated that HBOT induced hippocampal neuroplasticity in veterans with long-standing treatment-resistant PTSD; this led to enhanced memory recovery and significant improvement in PTSD symptoms. Both physical activity, such as aerobic exercise, and cognitive training were shown to support neurogenesis in the hippocampus. Therefore, the current study aims to evaluate whether hippocampal training, induced by physical and cognitive training, will augment the hippocampal neuroplasticity effect of HBOT and further enhance recovery of inaccessible memories in veterans with PTSD. The protocol will include forty male veterans aged 25 to 60 years, with combat-associated PTSD and peritraumatic amnesia, who will receive either HBOT alone or HBOT and hippocampal training. The HBOT protocol will consist of 60 daily sessions, 90-minutes each, five days a week. Hippocampal training will combine physical and cognitive training 3 times per week, prior to HBOT sessions. Detailed psychological evaluation, anatomic and functional MRI, electroencephalogram and autonomic nervous system data will be obtained at baseline, and during and after treatment. The proposed study offers a new approach of biological treatment for memory manipulations. The findings will help elucidate the mechanism of PTSD-related memory impairment and is expected to contribute to the development of biological memory manipulations for treating PTSD and other memory-related conditions.

Conditions

PTSD; Peritraumatic Amnesia

Outcome Measures

Primary Outcomes (2)

• Changes in memory gaps (as assessed by the traumatic scene form)

  traumatic scene form will be used to assess memory gaps. The intensity of each part sensation will be scored between 0 and 10 (higher score reflects stronger memory). A time line of the event will be drown, and amnestic parts of the memory will be marked (the presumed amnestic time will be evaluated in minutes)

  through study completion, an average of 4 months

• Time to inaccessible memory surfacing

  Daily questionnaire will be used to assess surfacing of new memories. The time of memory surfacing will be defined (session number)

  through study completion, an average of 4 months

Secondary Outcomes (5)

• Change in brain activity as assessed by fMRI (functional magnetic resonance imaging)

  through study completion, an average of 4 months

• cognitive performance as assessed using "Neurotrax"

  through study completion, an average of 4 months

• RAVLT memory test

  through study completion, an average of 4 months

• ROCFT memory test

  through study completion, an average of 4 months

• Verbal Pairs memory test

  through study completion, an average of 4 months

Study Arms (2)

HBOT

ACTIVE COMPARATOR

Participants will be treated in a multiplace chamber (HAUX-Life-Support GmbH) for a total of 60 daily sessions, five days a week. Each session will consist of 90 minutes exposure to 100% oxygen at 2 ATA (atmospheres), with five-minute air brakes every 20 minutes.

Other: HBOT

HBOT + hippocampal training

ACTIVE COMPARATOR

Participants will be treated in a multiplace chamber (HAUX-Life-Support GmbH) for a total of 60 daily sessions, five days a week. Each session will consist of 90 minutes exposure to 100% oxygen at 2 ATA, with five-minute air breaks every 20 minutes. Hippocampal training: This will combine physical and cognitive training. Training will be given 3 times per week, prior to the next HBOT, and more than 20 hours after the last HBOT session.

Other: HBOT; Other: Hippocampal training

Interventions

HBOT OTHER

Participants will be treated in a multiplace chamber (HAUX-Life-Support GmbH) for a total of 60 daily sessions, five days a week. Each session will consist of 90 minutes exposure to 100% oxygen at 2 ATA, with five-minute air breaks every 20 minutes.

HBOT; HBOT + hippocampal training

Hippocampal training OTHER

Hippocampal training: This will combine physical and cognitive training. Training will be given 3 times per week, prior to the next HBOT, and more than 20 hours after the last HBOT session.

HBOT + hippocampal training

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: Only male will be recruited to the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of PTSD
• A history of trauma of at least one course of trauma-focused psychotherapy
• The presence of peri-traumatic amnesia

You may not qualify if:

• A history of traumatic brain injury or any other known brain pathology except PTSD
• Active smoking
• Drugs or alcohol abuse other than prescribed cannabis
• Active asthma, lung pathology, epilepsy or otolaryngological disease incompatible with HBOT
• The presence of shards or another contraindication for MRI

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Weizmann Institute of Science: collaborator
• Office of Naval Research (ONR): collaborator

Study Sites (1)

Assaf-Harofeh Medical Center

Ramla, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

keren Doenyas-Barak, MD

CONTACT

0544215487; kerendoenyas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care providers, Investigator and assessors will be blinded to the participants' allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be recruited from veterans' clinics and veterans' organizations. After screening, eligible participants will undergo baseline evaluation. Enrolled participants will be 1:1 randomly assigned to the HBOT or HBOT + hippocampal training, according to a computer-generated randomization list. Assessors will be blinded to the participants' allocation. During the study period, all the participants will continue their psychological and pharmacological treatment as prior to their inclusion in the study. Any changes in the frequency of psychologic treatment or pharmacotherapy dose will be reported and documented. The study is designed as a per protocol trial, and thus, participants will only be included in the analysis if they completed the treatment protocol and attained study analysis.

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: June 1, 2023
• Study Start: May 25, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)