MindRhythm Detection of Concussion and Recovery Study
- Conditions
- mTBI - Mild Traumatic Brain Injury
- Registration Number
- NCT07190963
- Lead Sponsor
- MindRhythm, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
An individual who has been diagnosed with or suspected to have a concussion or mTBI.
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open wounds on the head. Pregnant women due to unexpected risks. Subjects under the age of 4.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. Subject data will be acquired for approximately 30 days from subject enrollment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MindRhythm Incorporated
🇺🇸Cupertino, California, United States
MindRhythm Incorporated🇺🇸Cupertino, California, United StatesBeth Johnson Director of Commercial Development, BAContact8608368630Beth.Johnson@mindrhythm.comPaul Lovoi, PhDPrincipal Investigator