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Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

NCT02849002 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2023-07-07

No results posted yet for this study

Summary

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. 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.BrainPulse(TM)

Conditions

  • Mild Traumatic Brain Injury

Interventions

DEVICE

BrainPulse

Jan Medical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle, referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to the brain motion using an array of sensors placed on the head.

Sponsors & Collaborators

  • Jan Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Neilank Jha, MD · Konkussion

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-14
Primary Completion
2016-09-29
Completion
2016-09-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02849002 on ClinicalTrials.gov