Diagnosis of mTBI in a Community Setting

NCT03539848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-02

No results posted yet for this study

Summary

The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.

Conditions

Interventions

DEVICE

I-PAS Goggles

Portable, head-mounted display goggle system with integrated eye capture technology

Sponsors & Collaborators

  • Neurolign

    collaborator INDUSTRY
  • University of Miami

    lead OTHER

Principal Investigators

  • Michael Hoffer, MD · University of Miami

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
2018-08-01
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03539848 on ClinicalTrials.gov