Status:
COMPLETED
A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder
Lead Sponsor:
EarliTec Diagnostics, Inc
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
16-30 years
Brief Summary
This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to participate in this study:
- Boys and girls between 16 and 30 months of age
- Generally healthy with no acute illnesses by physical examination
- Normal or corrected-to-normal vision, in terms of visual acuity and oculomotor function, sufficient to watch short videos. Adequate hearing to hear material presented in videos
- Subject and parent can communicate meaningfully in English with the principal investigator and the clinical study site staff
- Subject's parent or guardian is able to read and understand the informed consent form
- Parent voluntarily provides written informed consent
Exclusion
- Any subject who meets any of the exclusion criteria will be excluded from participation in this study:
- Known genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, Muscular Dystrophy, Neurofibromatosis, Down Syndrome)
- Severe hearing or visual impairment as determined on physical examination (e.g., congenital nystagmus, congenital cataracts, previous diagnosis of severe hearing deficits by otoacoustic emissions or auditory brainstem response)
- Acute illnesses likely to prevent successful or valid data collection, i.e., conjunctivitis, fever, uncontrolled allergy symptoms, etc.
- Uncontrolled epilepsy or seizure disorder
- History or presence of a clinically significant medical disease, or a mental state that might confound the study or be detrimental to the subject as determined by the investigator
- Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
- Receiving therapies that may affect vision, i.e., currently receiving or have received the following therapies within 2 weeks of screening: topiramate, chlorpromazine, thioridazine, prednisone, prednisolone (including ophthalmic solutions and ointments), diphenhydramine, or hydroxyzine; or have received ophthalmic antibiotics within 3 days of screening: tobramycin, ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin and ofloxacin solutions and/or bacitracin ointment
- Receiving therapies that may affect the ability to focus attention on the videos, i.e., if on central nervous system (CNS) stimulants, CNS depressants, or anticonvulsants, dose must be stable (same dose for at least 2 weeks).
- Known allergies or sensitivity to the plastic, leather, or metal components used in the materials of the Social Developmental Testing Device seat
- Unable or unwilling to sit in a car seat, e.g., child has tantrums on nearly all occasions when placed in a car seat and tantrums do not subside within 5 minutes
Key Trial Info
Start Date :
April 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT03469986
Start Date
April 7 2018
End Date
May 31 2019
Last Update
November 8 2023
Active Locations (6)
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1
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Emory University
Atlanta, Georgia, United States, 30329
4
Rush University Medical Center
Chicago, Illinois, United States, 60612