HeadPulse for detecting concussion and tracking recovery
Detection of Concussion and Recovery Study
MindRhythm, Inc. · NCT07190963
This project will test whether the HeadPulse device can detect concussion and track recovery in people age 4 and up who have had a mild traumatic brain injury, with a focus on athletes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | MindRhythm, Inc. (industry) |
| Locations | 2 sites (Cupertino, California and 1 other locations) |
| Trial ID | NCT07190963 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people age 4 and older who have been diagnosed with or are suspected to have a concussion or mTBI, especially athletes or those with recent sport-related head injuries, who can attend visits at the Cupertino site.
Not a fit: People with open wounds on the head, pregnant women, children under age 4, or individuals without a suspected concussion are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, HeadPulse could offer an objective, noninvasive digital biometric to help decide when it is safe to return to play or normal activities after a concussion.
How similar studies have performed: Earlier HeadPulse data collected in professional athletes showed promising signals, but broader validation in youth and nonprofessional athletes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: An individual who has been diagnosed with or suspected to have a concussion or mTBI. \- Exclusion Criteria: open wounds on the head. Pregnant women due to unexpected risks. Subjects under the age of 4. \-
Where this trial is running
Cupertino, California and 1 other locations
- MindRhythm Incorporated — Cupertino, California, United States (ENROLLING_BY_INVITATION)
- MindRhythm Incorporated — Cupertino, California, United States (RECRUITING)
Study contacts
- Study coordinator: Beth Johnson-Reich
- Email: beth.johnson@mindrhythm.com
- Phone: 8608368630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: mTBI - Mild Traumatic Brain Injury