Status:

ENROLLING_BY_INVITATION

A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Lead Sponsor:

Michael Harl

Conditions:

Mild Traumatic Brain Injury (mTBI)

Brain Injury

Eligibility:

MALE

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 7 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT06901310

Start Date

August 7 2025

End Date

December 31 2026

Last Update

August 13 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Marshfield Clinic

Marshfield, Wisconsin, United States, 54449