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Search / Trial NCT06901310

A Feasibility Study in Combat Athletes with Mild Traumatic Brain Injury

Launched by MICHAEL HARL · Mar 24, 2025

Trial Information

Current as of May 09, 2025

Not yet recruiting

Keywords

M Tbi, Brain Injury, Concussion

ClinConnect Summary

This clinical trial is looking at a new treatment for athletes who have experienced a mild traumatic brain injury (mTBI), often caused by impacts in sports. Instead of just resting after the injury, the study will explore whether Hyperbaric Oxygen Therapy (HBOT) can help these athletes recover better and faster. Researchers will also use a special test to measure a protein called GFAP, which may help doctors decide when it's safe for athletes to return to their sport after an injury. This study is important because it aims to offer new ways to treat and understand mTBI, especially in combat sports, where these injuries can have serious long-term effects.

To participate in this trial, athletes must be male and fall within a certain age range. They also need to meet specific criteria based on how severe their injury was, which is determined by how long they are suspended from their sport due to the injury. The athletes will be randomly assigned to either receive HBOT or the standard treatment of rest. While the study is not yet recruiting participants, those who take part can expect to contribute to important research that may improve care for athletes with similar injuries in the future.

Gender

MALE

Eligibility criteria

  • Patients meeting the inclusion criteria will be based on the type of associated suspension; 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). These suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. The suspension group injury severity would not include moderate to severe GCS \<13. 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.

About Michael Harl

Michael Harl is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a robust background in clinical development and regulatory compliance, Mr. Harl oversees a diverse portfolio of clinical trials across various therapeutic areas. His focus on innovation and collaboration fosters strong partnerships with research institutions and healthcare professionals, ensuring the highest standards of quality and integrity in trial execution. Through his leadership, Michael Harl aims to contribute to the development of safe and effective treatments that address unmet medical needs.

Locations

Marshfield, Wisconsin, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported