A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

N/AEnrolling By InvitationNCT06901310

Michael Harl10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mild Traumatic Brain Injury (mTBI)Brain Injury Concussion

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Impact Neurological Scores

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

Time frame: 13 Weeks