Accession Number:

AD1033644

Title:

Safety and Efficacy of the BrainPort V100 Device in Individuals Blinded by Traumatic Injury

Descriptive Note:

Technical Report,25 Sep 2014,24 Sep 2016

Corporate Author:

Wicab, Inc. Middleton United States

Personal Author(s):

Report Date:

2016-12-01

Pagination or Media Count:

12.0

Abstract:

This study is a prospective, single-arm, multicenter clinical investigation. The aim of this study is to evaluate the functional performance of the BrainPort V200 device, a non-surgical, FDA approved, sensory substitution system, in persons who are profoundly blind due to a traumatic injury cortical or ocular. The device, which provides visual information via electrotactile stimulation on the tongue, is designed to enhance independence in performing activities of daily life. Nine out of the 20 projected participants have been enrolled across study sites. Participants have received ten hours of device training and have taken the device home to use in their everyday environments for the next 12 months. Functional performance measures of object identification, place setting identification, orientation and mobility, and word identification were assessed at baseline and post-device training. Follow-up assessments will be completed at 3, 6, 9, and 12 months. The psychosocial impact of assistive devices and general self-efficacy were assessed at baseline and will be measured a second time at the end of the study. Device-related adverse events will be reported throughout the study to evaluate the risks associated with the BrainPort V200. The remaining 11 participants have been recruited and will be enrolled within the next quarter.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE