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Validation of Brain Function Assessment Algorithm for mTBI/Concussion

NCT03671083 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 309

Last updated 2019-05-23

No results posted yet for this study

Summary

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

Conditions

  • Brain Injuries, Traumatic
  • Concussion, Mild
  • Concussion, Severe
  • Concussion, Intermediate
  • Concussion, Brain

Interventions

DEVICE

BrainScope Ahead 300iP

The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment, Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.

Sponsors & Collaborators

  • BrainScope Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Leslie Prichep, Ph.D. · BrainScope Company, Inc.

Eligibility

Min Age
13 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-03-01
Completion
2019-03-29
FDA Device
Yes

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 NCT03671083 on ClinicalTrials.gov