Recruiting

Observational Study

Sponsor:

MindRhythm, Inc.

Code:

NCT07190963

Conditions

mTBI - Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Study Details

Brief 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

Study ID

NCT07190963

Start date

Jan 28, 2025

Status verified date

Sep, 2025

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Jan 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

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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Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Concussed

An individual who is diagnosed or suspected of having a mTBI or concussion

Normal

An individual who has not been diagnosed or suspected of having a mTBI or concussion within one preceding year

Primary outcome measure

  • The primary endpoint is measurement and aggregate evaluation of the time course of HeadPulse abnormalities and the proportion of subjects who later worsen following clearance to return to activities. [ Time Frame: Subject data will be acquired for approximately 30 days from subject enrollment ]

Central Contacts and Locations

Central contacts

Beth Johnson-Reich

8608368630beth.johnson@mindrhythm.com

Locations

MindRhythm Incorporated

Recruiting

Cupertino, California, United States, 95014

Contacts

Beth Johnson Director of Commercial Development, BA

8608368630Beth.Johnson@mindrhythm.com

Principal Investigator:

Paul Lovoi, PhD

More Information

Sponsor

MindRhythm, Inc.

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MindRhythm, Inc. on 2025-09-24.