Mild Traumatic Brain Injury (mTBI)NCT06901310
A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
A study testing Hyberbaric Oxygen Therapy in people with Mild Traumatic Brain Injury (mTBI) and Brain Injury, run by Michael Harl at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury (mTBI), Brain Injury, Concussion
- What is being tested?
- Hyberbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
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
- Being tested
- Hyberbaric Oxygen Therapy
- Keywords
- brain injury, concussion, Mild traumatic brain injury (mTBI)
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyberbaric Oxygen TherapyDevice
Treating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments.
| Study group | Role | What they receive |
|---|---|---|
| HBOT Treatment Group | Experimental | Not described Receives: Device: Hyberbaric Oxygen Therapy |
| Conventional Rest Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start7 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain Injury (mTBI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Harl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Harl, Marshfield Clinic Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901310
- Sponsor's protocol ID
- HAR10123
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06901310
- Acronym / sponsor ID
- HAR10123
- Conditions
- Mild Traumatic Brain Injury (mTBI), Brain Injury, Concussion
- Keywords
- brain injury, concussion, Mild traumatic brain injury (mTBI)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Michael HarlUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT Treatment Group | Experimental | Device: Hyberbaric Oxygen Therapy |
| Conventional Rest Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyberbaric Oxygen TherapyTreating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments. | Device | HBOT Treatment Group |
Primary outcome
Impact Neurological Scores
Time frame: 13 Weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyberbaric Oxygen Therapy in people with Mild Traumatic Brain Injury (mTBI) and Brain Injury, run by Michael Harl at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact Neurological Scores (time frame: 13 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.