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Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

NCT04074486 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1318

Last updated 2022-06-10

No results posted yet for this study

Summary

This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).

Conditions

  • Brain Injuries
  • Concussion, Mild
  • Concussion, Brain
  • Near Point Convergence
  • Concussion, Intermediate

Interventions

DEVICE

BrainScope Ahead 300iP-O

BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.

DIAGNOSTIC_TEST

SCAT5

Sports Concussion Assessment Tool 5

DIAGNOSTIC_TEST

Near Point Convergence

Manual ocular function measurement conducted only if electronic version on device fails

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • BrainScope Company, Inc.

    lead INDUSTRY

Principal Investigators

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

Eligibility

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

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2022-01-31
Completion
2022-03-31
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 NCT04074486 on ClinicalTrials.gov