Safety and Efficacy of the BrainPort V200 Device in Individuals Blinded by Traumatic Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event)
研究概览
简要总结
The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people who are profoundly blind. The BrainPort V200 translates images captured by a digital camera into electro-tactile stimulation presented on the user's tongue to perceive shape, size, location, and motion of objects within the environment. The purpose of this study is to evaluate the safety and functional performance of the BrainPort V200 device in individuals who have been medically documented as blind, light perception or worse, due to a traumatic injury (cortical or ocular).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A minimum age of 18 years at enrollment.
- •A documented vision diagnosis of light perception or worse bilaterally.
- •Blinded by traumatic injury (i.e., ocular or cortical trauma).
- •Minimum post 12 months diagnosis of blindness.
- •Previous completion of conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- •Ability to read (or have read to them) and understand study documents and procedures.
- •Ability to provide valid feedback regarding use of the BrainPort device.
- •Access to an accessible computer and internet connection.
- •Willing and able to complete all questionnaires, telephone conferences, device training, and study procedures required by the protocol, after completing an orientation period with the device.
- •Ability to operate a tablet computer.
排除标准
- •Current oral health problems determined by the participant's medical history and an examination of the oral cavity performed by study personnel.
- •History of injury to the tongue resulting in impaired sensation of use of the tongue.
- •Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue, numbness or lack of feeling of the tongue.
- •Piercings on the tongue.
- •Recent or planned oral surgery and/or dental work in the past three months (does not include routine dental health exams/cleanings).
- •Known neuropathies of the tongue or tactile system.
- •History of seizures or epilepsy.
- •If female, pregnant or breast feeding by self-report. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
- •People with implanted medical devices (i.e., pacemaker, deep brain stimulator, cochlear implant).
- •Any hearing impairments which prevents hearing the device announcements.
- •Any cognitive disabilities (such as Alzheimer's disease), as determined by medical history and/or the Telephone Inventory Cognitive Screening (TICS).
- •Participation in any other clinical trial or research while my confound results in either study.
- •Known allergy to nickel, gold, or any component of stainless steel.
- •Any medical condition that would interfere with performance on the assessments.
- •The Site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above.
结局指标
主要结局
To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event)
时间窗: 12 months
The primary safety objective is to demonstrate no occurrence of a clinically significant device-related adverse event.
To assess the efficacy of the BrainPort device as measured by an object recognition task (to demonstrate at least 35% of subjects achieve a success rate in object recognition exceeding that expected by chance alone)
时间窗: 12 months
The primary efficacy objective is to demonstrate that at least 35% of subjects achieve a success rate in object recognition exceeding that expected by chance alone.
次要结局
未报告次要终点