Trials / Enrolling By Invitation
Enrolling By InvitationNCT06810193
Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Aerobic exercise | 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. |
Timeline
- Start date
- 2025-07-23
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2025-02-05
- Last updated
- 2025-09-11
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06810193. Inclusion in this directory is not an endorsement.