NCT04107610

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

September 25, 2019

Last Update Submit

March 2, 2021

Conditions

Healthy

Keywords

oculomotor,vestibular,concussion,mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Normative data for I-PAS tests

    Accuracy and gain across age: measurements of eye displacement versus stimulus displacement in saccadic and smooth pursuit tasks

    3 years

Secondary Outcomes (1)

  • Goggle evaluation

    3 years

Interventions

I-PASDEVICE

I-PAS is a portable, head-mounted display goggle system with integrated eye tracking technology. I-PAS records eye movements in response to visual and auditory stimuli.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • History of head injury characterized by any of the following:
  • Resulting from penetrating trauma
  • Resulting from an automobile accident with significant associated injuries
  • Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
  • Associated with a loss of consciousness period greater than 30 minutes
  • Judged to be more than mild by medical staff
  • Requiring admission to the hospital for any reason
  • Associated with subdural or epidural hemorrhage
  • 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
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Aura Kullmann, PhD

    Neuro Kinetics/Neurolign

    PRINCIPAL INVESTIGATOR

  • ALEXANDER D KIDERMAN, PhD

    Neuro Kinetics/Neurolign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aura Kullmann, PhD

CONTACT

4129636649aura.kullmann@gmail.com

ALEXANDER D KIDERMAN, PhD

CONTACT

4129636649AKIDERMAN@NEURO-KINETICS.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

April 1, 2021

Primary Completion

January 31, 2022

Study Completion

August 31, 2022

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)