A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-07

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Mild Traumatic Brain Injury (mTBI) Brain Injury Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HBOT Treatment Group

Group Type EXPERIMENTAL

Hyberbaric Oxygen Therapy

Intervention Type DEVICE

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

Conventional Rest Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyberbaric Oxygen Therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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)