A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Part of paid clinical trials in Marshfield, Wisconsin.

Sponsor
Michael Harl
Study ID
NCT06901310
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hyberbaric Oxygen Therapy — DEVICE
    Treating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments.

Study Details

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).

Key Dates

Start date
Aug 7, 2025
Status verified
May 2025
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HBOT Treatment Group
  • No Intervention: Conventional Rest Control Group

Primary Outcome Measure

Impact Neurological Scores [ Time Frame: 13 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Marshfield ClinicMarshfieldWisconsin54449-

Find similar trials in Marshfield, WI

By research site
Marshfield Clinic· Marshfield, WI

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