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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06901310

Enrollment

Registered

2025-03-28

Start date

2025-08-07

Completion date

2026-12-31

Last updated

2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

brain injury, concussion, Mild traumatic brain injury (mTBI)

Brief 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).

Interventions

DEVICEHyberbaric Oxygen Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Impact Neurological Scores	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026