Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts

Conditions

• Head Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Aerobic exercise — OTHER
  After the end-of-season assessments, participants in the Intervention (Exercise or Stretching) arm will be randomized to 2 weeks of daily aerobic exercise for 30 minutes or to 30-minutes of prescribed stretching.

Study Details

The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.

Key Dates

Start date

Jul 23, 2025

Status verified

Sep 2025

Primary completion

Dec 1, 2029

Completion

Dec 1, 2029

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• No Intervention: Observational (Ad-Lib Exercise) Arm
  All participants will undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) at pre- and post-season and 2 weeks after the end of the season. For two weeks at the end of the sport season, participants will be instructed to refrain from sports involving head contact but to otherwise exercise ad-lib.
• Experimental: Intervention (Exercise or Stretching) Arm
  Athletes and athlete cadets will be administered OCT/A and a novel neurologic test battery at pre- and post-season, and 2 weeks after the end of the season. After the end-of-season assessments, participants will be randomized to 2 weeks of either 30 minutes of daily aerobic exercise or to 30-minutes of prescribed stretching.

Primary Outcome Measure

Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina) [ Time Frame: Pre-season and post-season, 2 weeks ]

Locations (3)

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