Normative Oculomotor and Vestibular Data in Pediatric Population

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04107610
• Other study ID #: Pediatric SBIR
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2021
• Source: Neurolign
• Contact: Aura Kullmann, PhD
• Phone: 4129636649
• Email: aura.kullmann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: August 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• I-PAS
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Allegheny Health Network	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Neurolign	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Goggle evaluation	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