Normative Oculomotor and Vestibular Data in Pediatric Population

Neurolign

Status

Unknown

Conditions

Healthy

Treatments

Device: I-PAS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04107610

Pediatric SBIR

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

Accepts Healthy Volunteers

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