A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Michael Harl

Status

Invitation-only

Conditions

Brain Injury

Concussion

Mild Traumatic Brain Injury (mTBI)

Treatments

Device: Hyberbaric Oxygen Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06901310

HAR10123

Details and patient eligibility

About

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).

Enrollment

10 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.