A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

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).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Mild Traumatic Brain Injury (mTBI) Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury Central Nervous System Diseases Concussion Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyberbaric Oxygen Therapy

Device

Treating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments.

Primary outcomes

Impact Neurological Scores

Time frame: 13 Weeks

The Impact scores are a percentile 1% to 100%. Any score under 50% is considered a need for neurological or primary care consultation for a concussion

Sponsors and collaborators

Lead sponsor

Michael Harl

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 28, 2025
Registry last updated: Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting