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The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm. Subjects may also consent for a 5 additional follow-ups over a 21-day period to compare the progression of change in their BrainPulse recordings.
Full description
The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. In order to gather sufficient variability, subjects with both confirmed concussion and suspected concussion will be included in the study as long as they meet eligibility criteria. BrainPulse recordings from subjects with suspected concussion will be compared to the recordings of subjects diagnosed with concussion. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization.
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Inclusion criteria
Age >= 5 years old
Suspected or confirmed concussion by medical professional
Not more than 3 days since injury/trauma event
Willing and able to participate in all required study evaluations and allow access to medical testing and records
Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject
Demonstrates a minimum of 3 of the following symptoms:
Exclusion criteria
406 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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