MedTrace Logo

Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)

NCT04372797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2026-01-22

No results posted yet for this study

Summary

This study will establish the capability of a suite of conventional tests and the Neurolign Dx\_100 I-PAS goggle system to reliably and objectively detect mTBI in an acute setting when comparing individuals with mTBI to controls with minor injuries in a similarly stressful environment.

Conditions

  • Mild Traumatic Brain Injury

Interventions

DEVICE

Diagnostic test

A battery of oculomotor tests

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • University of Miami

    collaborator OTHER

  • United States Naval Medical Center, San Diego

    collaborator FED

  • Carey Balaban

    lead OTHER

Principal Investigators

  • Carey D Balaban, PhD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04372797 on ClinicalTrials.gov