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NCT06901310

A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

ENROLLING BY INVITATION NA Last updated 13 August 2025
What this trial tests

NA trial testing Hyberbaric Oxygen Therapy in Mild Traumatic Brain Injury (mTBI) in 10 participants. Enrolling by invitation.

Timeline
7 August 2025
Primary endpoint
1 September 2026
31 December 2026

Quick facts

Lead sponsorMichael Harl
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment10
Start date7 August 2025
Primary completion1 September 2026
Estimated completion31 December 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Mild Traumatic Brain Injury (mTBI)

Currently open trials in the same condition.

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Data sources for this page

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