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NCT06901310
A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
NA trial testing Hyberbaric Oxygen Therapy in Mild Traumatic Brain Injury (mTBI) in 10 participants. Enrolling by invitation.
1 September 2026
Quick facts
| Lead sponsor | Michael Harl |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 7 August 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hyberbaric Oxygen Therapy
Conditions studied
- Mild Traumatic Brain Injury (mTBI) — all drugs for Mild Traumatic Brain Injury (mTBI) →
- Brain Injury — all drugs for Brain Injury →
- Concussion — all drugs for Concussion →
Sponsor
Michael Harl
Who can join
18 and older, male only, with Mild Traumatic Brain Injury (mTBI) or Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06901310
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mild Traumatic Brain Injury (mTBI)
Currently open trials in the same condition.
- NCT06855186 — Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C) · NA · recruiting
- NCT07311486 — Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06901310 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Michael Harl
- Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06901310.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing