A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
Enrolling by invitation · Not applicable
Conditions studied: Mild Traumatic Brain Injury (mTBI), Brain Injury, Concussion
In brief
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).
Key facts
- Study ID
- NCT06901310
- Run by
- Michael Harl
- People needed
- 10
- Starts
- 2025-08-07
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-08-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Marshfield Clinic — Marshfield, Wisconsin, United States
Full record on ClinicalTrials.gov
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