MindRhythm Detection of Concussion and Recovery Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: mTBI - Mild Traumatic Brain Injury. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Detection of Concussion and Recovery Study
Overview
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.
Primary outcome measures
- 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]
Eligibility 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- MindRhythm Incorporated — Cupertino
- MindRhythm Incorporated — Cupertino
Identifiers
NCT: NCT07190963 · mTBI-002MR