MindRhythm Detection of Concussion and Recovery Study

Part of paid clinical trials in Cupertino, California.

Sponsor
MindRhythm, Inc.
Study ID
NCT07190963
Status
Recruiting
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Conditions

  • mTBI - Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jan 28, 2025
Status verified
Sep 2025
Primary completion
Jan 28, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Concussed
    An individual who is diagnosed or suspected of having a mTBI or concussion
  • Arm: 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

Locations (2)

FacilityCityStateZIPSite coordinators
MindRhythm IncorporatedCupertinoCalifornia95014-
MindRhythm IncorporatedCupertinoCalifornia95014
Beth Johnson Director of Commercial Development, BA
[email protected]
8608368630
Paul Lovoi, PhD
Paul Lovoi, PhD (PRINCIPAL_INVESTIGATOR)

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MindRhythm Incorporated· Cupertino, CA

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