mTBI - Mild Traumatic Brain Injury
Conditions
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.
Interventions
None listed
Sponsors
MindRhythm, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactBeth Johnson-Reich
Outcome results
None listed