Observational Study of HeadPulse to Detect and Monitor Concussion and Recovery in Individuals Aged 4 and Older

What this Trial Is About

Researchers are evaluating the use of the HeadPulse device to observe data in individuals, including children as young as 4 years old, who have experienced a concussion or mild traumatic brain injury mTBI. This observational study focuses on sports teams where the risk of concussion is higher and aims to confirm previous findings from professional athletes. The goal is to validate the HeadPulse as a digital biometric tool that can objectively indicate ongoing brain concussion even when a person feels no symptoms, supporting safer decisions for returning to play or normal activities. Participants include those diagnosed or suspected of having a concussion or mTBI and those without such diagnosis in the previous year. The study compares data from these groups to better understand concussion recovery. Data collection will occur over approximately 30 days after enrollment, focusing on HeadPulse abnormalities and monitoring if subjects worsen after being cleared to resume activities. Participants will be observed with HeadPulse measurements and evaluations during the study period. Researchers will monitor the time course of biometric abnormalities and the proportion of subjects who experience worsening symptoms after being cleared for activity. The study involves no treatment intervention but collects data to support device development. Participation may last around 30 days from enrollment, with ongoing safety and recovery assessments throughout this time.

MindRhythm Detection of Concussion and Recovery Study