HealthyNCT04107610
Normative Oculomotor and Vestibular Data in Pediatric Population
A study testing I-PAS in people with Healthy, run by Neurolign at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- I-PAS
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males or females age 6 to 18 years of all races.
- Parental/guardian permission (informed consent) and child assent
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
MICHAEL HOFFER, PhD, 305-243-1484, michael.hoffer@miami.edu
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Edward Snell, MD, Edward.SNELL@ahn.org
Angela Filmore, 412-359-8805, Angela.Finamore@ahn.org
About this study
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
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.
- Conditions
- Healthy
- Being tested
- I-PAS
- Keywords
- oculomotor,, vestibular,, concussion,, mild traumatic brain injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PASDevice
I-PAS is a portable, head-mounted display goggle system with integrated eye tracking technology. I-PAS records eye movements in response to visual and auditory stimuli.
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative data for I-PAS tests
Accuracy and gain across age: measurements of eye displacement versus stimulus displacement in saccadic and smooth pursuit tasks
Measured: 3 years
Secondary outcomes (1)
Goggle evaluation
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Apr 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurolign
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Miami
- Responsible party
- Sponsor
- Investigators
- Aura Kullmann, PhD, Principal investigator, Neuro Kinetics/NeurolignALEXANDER D KIDERMAN, PhD, Principal investigator, Neuro Kinetics/Neurolign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107610
- Sponsor's protocol ID
- Pediatric SBIR
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04107610
- Acronym / sponsor ID
- Pediatric SBIR
- Conditions
- Healthy
- Keywords
- oculomotor,, vestibular,, concussion,, mild traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- NeurolignIndustry (pharma, biotech, devices)
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), University of Miami
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Males or females age 6 to 18 years of all races.
- Parental/guardian permission (informed consent) and child assent
Key exclusion criteria (39 listed)
- History of head injury characterized by any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PASI-PAS is a portable, head-mounted display goggle system with integrated eye tracking technology. I-PAS records eye movements in response to visual and auditory stimuli. | Device | – |
Primary outcome
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
1 secondary outcome
Goggle evaluation
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aura Kullmann, PhD principal investigator
Neuro Kinetics/Neurolign
ALEXANDER D KIDERMAN, PhD principal investigator
Neuro Kinetics/Neurolign
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-PAS in people with Healthy, run by Neurolign at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aura Kullmann, PhD (4129636649, aura.kullmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative data for I-PAS tests (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.