Status:
UNKNOWN
Normative Oculomotor and Vestibular Data in Pediatric Population
Lead Sponsor:
Neurolign
Collaborating Sponsors:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
University of Miami
Conditions:
Healthy
Eligibility:
All Genders
6-18 years
Phase:
NA
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 neu...
Eligibility Criteria
Inclusion
- Males or females age 6 to 18 years of all races.
- Parental/guardian permission (informed consent) and child assent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04107610
Start Date
April 1 2021
End Date
August 31 2022
Last Update
March 3 2021
Active Locations (2)
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1
University of Miami
Miami, Florida, United States, 33136
2
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212