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

NCT02812225 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 406

Last updated 2022-06-09

No results posted yet for this study

Summary

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.

Conditions

  • Brain Concussion
  • 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

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

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 NCT02812225 on ClinicalTrials.gov