A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyberbaric Oxygen Therapy.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury (mTBI), Brain Injury, Concussion. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
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).
Interventions
- Device Hyberbaric Oxygen Therapy
Treating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments.
Primary outcome measures
- Impact Neurological Scores [Time frame: 13 Weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Marshfield Clinic — Marshfield
Identifiers
NCT: NCT06901310 · HAR10123