Clinical Trial

A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Enrolling by Invitation
View on ClinicalTrials.gov →
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-24; most recent amendment 2025-08-11.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-08-11
Trial Details
NCT Number NCT06901310
Lead Sponsor Michael Harl
Conditions Mild Traumatic Brain Injury (mTBI), Brain Injury, Concussion
Enrollment 10 participants
Start Date 2025-08-07
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-13