Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children
Blindness
About this trial
This is an interventional treatment trial for Blindness
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
- 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).
Sites / Locations
- UPMC Eye Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Blind Children
Sighted 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.
Children between the ages of 4 and 17 who are sighted in both eyes.