Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
Public ClinicalTrials.gov record NCT04974307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Study of an Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: CLN3 involves vision loss observed around the preschool years, with eventual progression to blindness within 1-3 years. Researchers want to test an assistive device that may help children with CLN3 or with non-CLN3 related blindness. Objective: To learn if it is safe, easy, and useful for children with CLN3 or with non-CLN3 related blindness to use the OrCam. Eligibility: People aged 6-18 years who have either CLN3-related disease or non-CLN3 related blindness. Design: Participants will be screened with the following: Medical history Physical exam Family history Eye exam and vision tests. They will get eyedrops to dilate their eyes. Psychological and neurocognitive tests. They will be asked questions and observed for how they do various tasks, such as talking, playing, writing, drawing, and solving problems. Hearing tests. They may wear headphones or earplugs. Electrodes may be taped to their head. Blood samples Skin biopsy, if needed Cheek cell, saliva, or urine samples The OrCam is the size of and weighs about half as much as a pack of gum. It is attached to eyeglass frames by magnets. Participants will do tasks before and after they have been trained on the OrCam. They will do these tasks without or with using the OrCam. Participants will be given an OrCam to use for 1 week or 1 month. They will have check-in sessions with the study team. Participants and/or their caregivers will be asked about abilities, behaviors, social skills, learning methods, intelligence, and health-related quality of life. Participants samples may be used for genetic testing and/or to make a type of stem cell. Participation will last for 1-5 weeks.
Study identification
- NCT ID
- NCT04974307
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- 11 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 29, 2021
- Primary completion
- Oct 5, 2023
- Completion
- Oct 6, 2023
- Last update posted
- Oct 22, 2024
2021 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04974307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04974307 live on ClinicalTrials.gov.