Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children

Stopped early · Not applicable

Conditions studied: Blindness

In brief

The BrainPort vision device is a visual prosthetic designed for those who are blind. It enables perception of visual information using the tongue and camera system as a paired substitute for the eye. Visual information is collected from a video camera and translated into a gentle vibration that is presented to the subject on the tongue. With training users perceive shape, size, location and motion of objects in their environment. It is a functional, non-surgical device developed to demonstrate as an aid to the visually impaired. The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision device) that enables the blind to appreciate their immediate surroundings and determine the way the brain interprets the information. Our goal is to determine if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.

Key facts

Study ID: NCT03002597
Run by: Ellen Mitchell
People needed: 9
Starts: 2014-01-01
Expected to finish: 2021-06-01
Last updated by the study team: 2023-08-16

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Blind Children:
Between the age of 4 and 17.
Blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.
Able to understand and sign the Informed Consent and Assent form.
Able to understand the training and rehabilitation protocols involved in the study.
Willing to use the BrainPort device.
Able to undergo functional neuroimaging tests
Sighted Children:
Between the age of 4 and 17.
Sighted in both eyes from an eye care provider.
Able to understand and sign the Informed Consent and Assent form.
Able to understand the training and rehabilitation protocols involved in the study.
Willing to use the BrainPort device.
Able to undergo functional neuroimaging tests

You may not qualify if…

Blind Children:
Current oral health problems as determined by the subject's history, and an examination of the oral cavity performed by a member of the study team. Subject is excluded if any of the following conditions are met:
A history of injury to the tongue resulting in impaired sensation or use of the tongue.
Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue.
Oral surgery or dental work in the past 3 months or anticipated to occur for the duration of participation in the study (does not include routine dental health exams/cleanings).
Piercing on the tongue.
Performance better than 20/5000 on the FrACT acuity test (same visual criteria as FDA safety study).
Known neuropathies of tongue or skin tactile system.
Unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests and follow up visits.
Implanted electrical medical devices such as pacemakers.
Known allergies to nickel, gold or other components of stainless steel.
Patients who are 18 years and older or younger than 4.
Women who are pregnant or breast feeding will not be able to participate in this study (as indicated by a positive pregnancy test).
Children with neurodevelopmental disorders (e.g., autism, learning disabilities) or congenital brain malformations will be excluded from participation.
Cortical blindness from any cause.
Claustrophobia that would prevent functional neuroimaging (for those subjects undergoing neuroimaging only).
Obesity preventing placement in MRI scanner (for those subjects undergoing neuroimaging only).
Presence of any foreign metal in the body with the exception of dental fillings.
Implanted metallic or ferromagnetic objects (aneurysm clip, ear implant, IUD, shrapnel or metallic fragments in or on the body or eyes, neuro-stimulators, or other metal devices).
Sighted Children:
Current oral health problems as determined by the subject's history, and an examination of the oral cavity performed by a member of the study team. Subject is excluded if any of the following conditions are met:
A history of injury to the tongue resulting in impaired sensation or use of the tongue.
Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue.
Oral surgery or dental work in the past 3 months or anticipated to occur for the duration of participation in the study (does not include routine dental health exams/cleanings).
Piercing on the tongue.

Where it is running

UPMC Eye Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.