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Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children

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ClinicalTrials.gov Identifier: NCT03002597
Recruitment Status : Active, not recruiting
First Posted : December 26, 2016
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ellen Mitchell, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Blindness Device: BrainPort V200 Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children
Study Start Date : January 2014
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Blind Children
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
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.

Experimental: Sighted Children
Children between the ages of 4 and 17 who are sighted in both eyes.
Device: BrainPort V200 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.




Primary Outcome Measures :
  1. Evaluate BrainPort Device [ Time Frame: 5 visits over the course of approximately 2 weeks ]
    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, and standardized object recognition tasks after use of the BrainPort.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Blind Children:

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

Sighted Children:

  1. Between the age of 4 and 17.
  2. Sighted in both eyes from an eye care provider.
  3. Able to understand and sign the Informed Consent and Assent form.
  4. Able to understand the training and rehabilitation protocols involved in the study.
  5. Willing to use the BrainPort device.
  6. Able to undergo functional neuroimaging tests

Exclusion Criteria:

Blind Children:

  1. 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:

    1. A history of injury to the tongue resulting in impaired sensation or use of the tongue.
    2. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue.
    3. 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).
    4. Piercing on the tongue.
    5. Performance better than 20/5000 on the FrACT acuity test (same visual criteria as FDA safety study).
  2. Known neuropathies of tongue or skin tactile system.
  3. Unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests and follow up visits.
  4. Implanted electrical medical devices such as pacemakers.
  5. Known allergies to nickel, gold or other components of stainless steel.
  6. Patients who are 18 years and older or younger than 4.
  7. Women who are pregnant or breast feeding will not be able to participate in this study (as indicated by a positive pregnancy test).
  8. Children with neurodevelopmental disorders (e.g., autism, learning disabilities) or congenital brain malformations will be excluded from participation.
  9. Cortical blindness from any cause.
  10. Claustrophobia that would prevent functional neuroimaging (for those subjects undergoing neuroimaging only).
  11. Obesity preventing placement in MRI scanner (for those subjects undergoing neuroimaging only).
  12. Presence of any foreign metal in the body with the exception of dental fillings.
  13. 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:

  1. 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:

    1. A history of injury to the tongue resulting in impaired sensation or use of the tongue.
    2. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue.
    3. 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).
    4. Piercing on the tongue.
  2. Known neuropathies of tongue or skin tactile system.
  3. Unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests and follow up visits.
  4. Implanted electrical medical devices such as pacemakers.
  5. Known allergies to nickel, gold or other components of stainless steel.
  6. Patients who are 18 years and older or younger than 4.
  7. Women who are pregnant or breast feeding will not be able to participate in this study (as indicated by a positive pregnancy test).
  8. Children with neurodevelopmental disorders (e.g., autism, learning disabilities) or congenital brain malformations will be excluded from participation.
  9. Cortical blindness from any cause.
  10. Claustrophobia that would prevent functional neuroimaging (for those subjects undergoing neuroimaging only).
  11. Obesity preventing placement in MRI scanner (for those subjects undergoing neuroimaging only).
  12. Presence of any foreign metal in the body with the exception of dental fillings.
  13. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002597


Locations
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United States, Pennsylvania
UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ellen Mitchell
Investigators
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Principal Investigator: Ellen Mitchell, MD Assistant Professor of Ophthalmology
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Responsible Party: Ellen Mitchell, Assistant Professor of Ophthalmology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03002597    
Other Study ID Numbers: PRO13090458
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases