HeadPulse for detecting concussion and tracking recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational protocol will collect HeadPulse digital biometric recordings from individuals aged 4 and older who have been diagnosed with or are suspected to have a concussion, focusing on sports teams where concussion risk is higher. Participants will have serial HeadPulse measurements over the course of recovery to capture acute changes and persistent signals without introducing any investigational treatments. The aim is to validate prior HeadPulse findings in professional athletes and determine whether the device can identify brains that remain concussed even when symptoms have resolved. Results are intended to support development of a device to guide safer return-to-play or return-to-activity decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria: An individual who has been diagnosed with or suspected to have a concussion or mTBI.

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Exclusion Criteria: open wounds on the head. Pregnant women due to unexpected risks. Subjects under the age of 4.

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Where it's running

• MindRhythm Incorporated
  Cupertino, California, United States Recruiting
• MindRhythm Incorporated
  Cupertino, California, United States Enrolling by invitation

Study contacts

• Study coordinator: Beth Johnson-Reich
• Email: beth.johnson@mindrhythm.com
• Phone: 8608368630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.