Normative Oculomotor and Vestibular Data in Pediatric Population

March 2, 2021 updated by: Neurolign

Development of a Pediatric Oculomotor and Vestibular Normative Database as an Essential Tool for Objective Evaluation of Concussion and Return-to-school/Play

The purpose of this study is to use a device called I-Portal® Portable Assessment System (I-PAS) to record eye movements in response to a number of visual and auditory stimuli designed to evaluate neural brain pathways related to oculomotor, vestibular, reaction time and cognitive (OVRT-C) development. The goal of this research is to collect normative data for the OVRT-C tests from a healthy pediatric population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females age 6 to 18 years of all races.
  • Parental/guardian permission (informed consent) and child assent

Exclusion Criteria:

  • History of head injury characterized by any of the following:

    1. Resulting from penetrating trauma
    2. Resulting from an automobile accident with significant associated injuries
    3. Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
    4. Associated with a loss of consciousness period greater than 30 minutes
    5. Judged to be more than mild by medical staff
    6. Requiring admission to the hospital for any reason
    7. Associated with subdural or epidural hemorrhage
    8. Persons with a previous history of mTBI in the past and who were symptomatic prior to current injury
  • Pregnancy, as documented by last menstrual period at study visits
  • Implants: Persons implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant, metal cervical spine hardware
  • Diagnosed with attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, major depression, hypochondriasis, bipolar disorders, or schizophrenia.
  • Presence of severe aphasia or inability to follow commands and give independent responses
  • Documented neurodegenerative disorders (Multiple sclerosis, Parkinson's, Alzheimer's, Huntington)
  • Past history of seizures or convulsions

  • Prior disorders of hearing and balance including:

    1. Meniere's disease
    2. Multiple sclerosis
    3. Vestibular neuritis
    4. Vestibular schwannoma
    5. Sudden sensorineural hearing loss
    6. History of ear operation other than myringotomy and tube placement in the past
    7. Acute or chronic disease of middle ear (infections, otitis)
  • History of cerebrovascular disorders including stroke, brainstem or cerebellar dysfunction within the last 3 months
  • Systemic disorders that include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, severe arthritis, diabetes, hypertension
  • Repeated history of syncope
  • Past or concomitant treatment with ototoxic chemotherapy
  • Previous contraindicating surgeries at the discretion of the study physician
  • Aminoglycosides in the past 6 months given via systemic or transtympanic administration

  • Concomitant treatment with any of the followings within the last 24 hours prior to testing if more than 2 doses have been taken:

    1. Antihistamines: e.g. diphenhydramine, cyclizine, dimenhydrinate, meclizine, hydroxyzine, promethazine,
    2. For ADHD and narcolepsy: e.g. Concerta, Daytrana, Methylin, Ritalin, Ritalin LA, Metadate ER, Aptensio XR, Cotempla XR-ODT, QuilliChew ER, and Quillivant XR
    3. For schizophrenia and other mental diseases: e.g. Phenothiazines
    4. Specific antibiotics: e.g. ethambutol, gentamycin
    5. Anticonvulsant medications: e.g. topiramate
  • Currently suffering from dehydration
  • History or suspicion of substance abuse or addiction
  • Acute alcohol intoxication
  • Playing professional sports at the Olympic/league level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normative data for I-PAS tests
Time Frame: 3 years
Accuracy and gain across age: measurements of eye displacement versus stimulus displacement in saccadic and smooth pursuit tasks
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goggle evaluation
Time Frame: 3 years
Short questionnaire consisting of 6 questions to assess the look, feel and weight of the goggles. 5 questions are Yes/No (0/1) and one question is on a rating from 0 to 3. The total score from these questions represents an evaluation of goggle comfort. The score can be between 0-8, where a score of 0 is indicative of a very good comfort level and a score of 8 of a low comfort level.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurolign

Collaborators

University of Miami
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigators

  • Principal Investigator: Aura Kullmann, PhD, Neuro Kinetics/Neurolign
  • Principal Investigator: ALEXANDER D KIDERMAN, PhD, Neuro Kinetics/Neurolign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pediatric SBIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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