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NCT00760734

HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial

Completed Phase 1 Last updated 16 April 2017
What this trial tests

Phase 1 trial testing Low pressure hyperbaric oxygen therapy in TBI (Traumatic Brain Injury) in 30 participants. Completed in 1 June 2011.

Timeline
1 September 2008
Primary endpoint
1 September 2010
1 June 2011

Quick facts

Lead sponsorPaul G. Harch, M.D.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 September 2008
Primary completion1 September 2010
Estimated completion1 June 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Paul G. Harch, M.D. — full company profile →

Who can join

Adults 18 to 65, any sex, with TBI (Traumatic Brain Injury) or Post Concussion Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Case control study: hyperbaric oxygen treatment of mild traumatic brain injury persistent post-concussion syndrome and post-traumatic stress disorder.
    Harch PG, Andrews SR, Fogarty EF, Lucarini J, et al · · 2017 · cited 30× · PMID 29152209 · DOI 10.4103/2045-9912.215745
  2. Hyperbaric oxygen therapy as a potential treatment for post-traumatic stress disorder associated with traumatic brain injury.
    Eve DJ, Steele MR, Sanberg PR, Borlongan CV. · · 2016 · cited 21× · PMID 27799776 · DOI 10.2147/ndt.s110126

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Data sources for this page

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