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Objective Brain Function Assessment of mTBI/Concussion in High School Athletes

NCT02661633 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 177

Last updated 2019-05-23

No results posted yet for this study

Summary

This study (Part 2) 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. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

Conditions

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

Interventions

DEVICE

BrainScope Ahead 200iD

The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.

DEVICE

Advanced MRI Neuroimaging

Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.

Sponsors & Collaborators

  • BrainScope Company, Inc.

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-29
Primary Completion
2017-01-31
Completion
2017-07-31

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 NCT02661633 on ClinicalTrials.gov