MindRhythm Detection of Concussion and Recovery Study
ConditionmTBI - Mild Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorMindRhythm, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Subjects who have experienced a mTBI/concussion compared to a cohort of cohort of neurologically normal individuals who have not experienced diagnosed or undiagnosed concussion or head trauma within the last 12 months.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Concussed
Group B: Normal
Trial outcomes
Primary outcomes
1
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 enrollmentSponsors and contacts
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Source ClinicalTrials.gov