NCT07190963

MindRhythm Detection of Concussion and Recovery Study

Detection of Concussion and Recovery Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: MindRhythm, Inc. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

Summary

This study is designed to observe HeadPulse data in concussed subjects that may have experienced a concussion via an injury down to the age of 4. Sports teams are the focus of this study because therein lies inherent potential risk for concussion. This observational study will further confirm the data previously collected in professional athletes to further validate that the HeadPulse can be used as a digital biometric to objectively indicate when a concussed brain remains concussed despite a subject feeling no symptoms has extreme value. This study is intended to support the development of a device to objectively determine when it is safe to return to play or normal activity based on the output of the digital biometric.

Conditions

• mTBI - Mild Traumatic Brain Injury

Timeline

• Start date: 2025-01-28
• Primary completion: 2027-01-28
• Completion: 2027-03-30
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

2 sites across 1 country: United States