Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Evaluate BrainPort Device
研究概览
简要总结
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.
详细描述
Objective:
Our objective is to determine if the functional improvements seen in blind subjects using the BrainPort can be realized in a pediatric cohort.
Specific Aims:
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 main 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.
As a second aim, the investigators will use a multimodal MR scanning session to study the neurophysiological basis of sensory substitution in children. Under this aim the investigators will pursue two main objectives. First, the investigators will correlate the behavioral data with the imaging data in order to detect regions of the brain where structure and/or function are associated with successful use of sensory substitution devices. Second, the investigators will utilize these data along with previously collected adult data to model the effects of prior visual experience on visual cortex plasticity due to blindness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blind Children:
- •Between the age of 4 and
- •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
- •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
排除标准
- •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
- •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
- •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).
结局指标
主要结局
Evaluate BrainPort Device
时间窗: 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 (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.
次要结局
未报告次要终点
研究者
Ellen Mitchell
Assistant Professor of Ophthalmology
University of Pittsburgh