NCT06901310

A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Michael Harl · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Mild Traumatic Brain Injury (mTBI)
• Brain Injury
• Concussion

Interventions

Type	Name	Description
DEVICE	Hyberbaric Oxygen Therapy	Treating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments.

Timeline

• Start date: 2025-08-07
• Primary completion: 2026-09-01
• Completion: 2026-12-31
• First posted: 2025-03-28
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study