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Objective Brain Function Assessment of mTBI/Concussion

NCT03963804 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 268

Last updated 2019-05-28

No results posted yet for this study

Summary

This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

Conditions

  • Brain Injuries, Traumatic
  • Concussion, Mild
  • Concussion, Intermediate
  • Concussion, Severe
  • 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 and 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
2018-06-11
Primary Completion
2019-01-25
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 NCT03963804 on ClinicalTrials.gov