Clinical trial NCT04107610: Normative Oculomotor and Vestibular Data in Pediatric Population
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: oculomotor,
vestibular,
concussion,
mild traumatic brain injury
Lead sponsor: Neurolign
Sponsor class: INDUSTRY
Collaborators: name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: University of Miami
First posted: 2019-09-27
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Normative data for I-PAS tests
timeFrame: 3 years
Secondary outcomes:
measure: Goggle evaluation
timeFrame: 3 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
Study officials:
affiliation: Neuro Kinetics/Neurolign
name: Aura Kullmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuro Kinetics/Neurolign
name: ALEXANDER D KIDERMAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: