A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

NCT06901310 | Enrolling By Invitation FDA Device

• 1 other identifier: HAR10123
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  13 Weeks

Study Arms (2)

HBOT Treatment Group

EXPERIMENTAL

Device: Hyberbaric Oxygen Therapy

Conventional Rest Control Group

NO INTERVENTION

Interventions

Hyberbaric Oxygen Therapy DEVICE

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

HBOT Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years or older
• Male Unarmed Combat Athlete
• day suspension (head injury without technical knockout or incapacitation)
• day suspension (head injury with technical knockout or incapacitation)
• day suspension (head injury with loss of consciousness)

You may not qualify if:

• Prisoner status
• Female
• Suspension group injury severity would not include moderate to severe GCS \<13

Sponsors & Collaborators

• Michael Harl: lead

Study Sites (1)

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician - Plastic Surgery

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 28, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)