- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04107610
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
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
- Name: Aura Kullmann, PhD
- Phone Number: 4129636649
- Email: aura.kullmann@gmail.com
Study Contact Backup
- Name: ALEXANDER D KIDERMAN, PhD
- Phone Number: 4129636649
- Email: AKIDERMAN@NEURO-KINETICS.COM
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
Contact:
- MICHAEL HOFFER, PhD
- Phone Number: 305-243-1484
- Email: michael.hoffer@miami.edu
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Health Network
-
Contact:
- Edward Snell, MD
- Email: Edward.SNELL@ahn.org
-
Contact:
- Angela Filmore
- Phone Number: 412-359-8805
- Email: Angela.Finamore@ahn.org
-
-
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:
- 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
Prior disorders of hearing and balance including:
- Meniere's disease
- Multiple sclerosis
- Vestibular neuritis
- Vestibular schwannoma
- Sudden sensorineural hearing loss
- History of ear operation other than myringotomy and tube placement in the past
- 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:
- Antihistamines: e.g. diphenhydramine, cyclizine, dimenhydrinate, meclizine, hydroxyzine, promethazine,
- For ADHD and narcolepsy: e.g. Concerta, Daytrana, Methylin, Ritalin, Ritalin LA, Metadate ER, Aptensio XR, Cotempla XR-ODT, QuilliChew ER, and Quillivant XR
- For schizophrenia and other mental diseases: e.g. Phenothiazines
- Specific antibiotics: e.g. ethambutol, gentamycin
- 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
Collaborators
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
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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