Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool

NCT02171312 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2016-02-09

No results posted yet for this study

Summary

The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain injury) system is a novel portable, open access platform that enables immediate and rapid assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT function testing battery with currently used balance and inner ear assessment methods during initial concussion clinic referral. Two groups of participants will be enrolled; a concussion related dizziness cohort and control subjects. The investigators will enroll the concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent dizziness and imbalance symptoms following possible concussion. Healthy control participants will be recruited from the local community. iDETECT's ability to identify post concussion balance/vestibular disturbances will be compared to an expert concussion assessment. Both cohorts will participate in the iDETECT assessment and the clinical assessment.

Conditions

  • Mild Concussion
  • Post Concussion Syndrome
  • Vestibular Neuritis

Interventions

DEVICE

iDETECT Assessment

The iDETECT device is an open platform for an evaluation of cognitive, balance, and oculomotor performance after mild traumatic brain injury (mTBI). It is a rugged, portable, neurocognitive assessment tool designed specifically for use in field and triage settings for the rapid evaluation of functional neurologic impairment after potential concussive injury. The apparatus includes an enhanced heads-up display visor with integration motion detection technology, noise-reducing headphones optimized with pink noise, and a handheld display for test battery administration, subject response inputs, and user data output. iDETECT will be used to assess multimodal neurologic function in participants.

BEHAVIORAL

Routine Balance and Vestibular Testing

A clinician will assess balance and vision by standard of care routine tests for neurologic function.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED
  • National Football League

    collaborator OTHER
  • General Electric

    collaborator INDUSTRY
  • UnderArmour

    collaborator UNKNOWN
  • Emory University

    lead OTHER

Principal Investigators

  • Russell Gore, MD · Sports Concussion Institute

  • David W Wright, MD · Emory University

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT02171312 on ClinicalTrials.gov