MindRhythm Detection of Concussion and Recovery Study (DISCOVERY)

MindRhythm

Status: Enrolling

Conditions: mTBI - Mild Traumatic Brain Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT07190963

mTBI-002MR

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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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Trial design

150 participants in 2 patient groups

Concussed

Description:

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

Normal

Description:

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