By InvitationNot Applicable

A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

United States10 participantsStarted 2025-08-07

Plain-language summary

The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 Years or older * Male Unarmed Combat Athlete * 30-day suspension (head injury without technical knockout or incapacitation) * 60-day suspension (head injury with technical knockout or incapacitation) * 90-day suspension (head injury with loss of consciousness) Exclusion Criteria: * Prisoner status * Female * Suspension group injury severity would not include moderate to severe GCS \<13 These suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. This group will be divided into randomized groups, patients who will be treated with HBOT and patients who will receive the standard of care, which is rest.

What they're measuring

Impact Neurological Scores

Timeframe: 13 Weeks

Trial details

NCT IDNCT06901310

SponsorMichael Harl

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01