Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children

NCT03002597 | Terminated Results

• 1 other identifier: STUDY19080134
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blindness

Outcome Measures

Primary Outcomes (1)

• Evaluate BrainPort Device

  The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.

  5 visits over the course of approximately 2 weeks

Study Arms (2)

Blind Children

EXPERIMENTAL

Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.

Device: BrainPort V200 Device

Sighted Children

EXPERIMENTAL

Children between the ages of 4 and 17 who are sighted in both eyes.

Device: BrainPort V200 Device

Interventions

BrainPort V200 Device DEVICE

To see 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.

Blind Children; Sighted Children

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Ellen Mitchell: lead

Study Sites (1)

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kanwal Nischal
• Organization: Children's Hospital of Pittsburgh UPMC

nischalkk@upmc.edu

4126928940

Study Officials

• Ellen Mitchell, MD

  Assistant Professor of Ophthalmology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 26, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Locations

US (1)