Normative Oculomotor and Vestibular Data in Pediatric Population
Status unconfirmed · Not applicable
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT04107610
- Run by
- Neurolign
- People needed
- 600
- Starts
- 2021-04-01
- Expected to finish
- 2022-08-31
- Last updated by the study team
- 2021-03-03
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: accepted.
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
- 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
Where it is running
- University of Miami — Miami, Florida, United States
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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