There is an immediate need for noninvasive therapies to improve the functional abilities of persons blinded by traumatic injury. The BrainPort Vision Pro, an updated hands-free oral electronic vision device, enables perception of visual information using the tongue as a substitute for the eye.
The purpose of this study was to evaluate the impact of the BrainPort Vision Pro on real-world functional task performance in persons who are profoundly blind (light perception or worse) due to traumatic injury (ocular or cortical).
This was a prospective, within-subjects, repeated-measures study. Participants received ten hours of device training and were required to use the device independently for 1 year. Functional performance measures of object identification, orientation and mobility, word identification, and environmental awareness were assessed at baseline, post-device training, and quarterly throughout the year.
Seventeen profoundly blind adults were enrolled in the study. No clinically significant device-related adverse events were reported, demonstrating minimal risks associated with the BrainPort Vision Pro. None of the participants could successfully perform any of the functional tasks at baseline, without the device. After 1 year of independent device use, all participants could identify objects, and 41% identified words beyond chance level while using the device. Forty-one percent of participants could locate a sign, 94% followed a line without veering off, 71% avoided obstacles, 71% walked through a doorway without collision, 100% of participants recognized a door, and 71% identified a window.
Results demonstrate significant improvements in real-world functional task performance in skill areas important to everyday life. The BrainPort Vision Pro offers a nonsurgical method for improving visual function in persons blinded by trauma. The device can enhance independence and support the successful integration of profoundly blind persons, including veterans and returning service members, into community life.
1Wicab, Inc., Middleton, Wisconsin
2The Chicago Lighthouse for People Who Are Blind or Visually Impaired, Chicago, Illinois
3Northeastern University, Boston, Massachusetts
4Lighthouse Guild, New York, New York *email@example.com
Submitted: February 1, 2018
Accepted: June 19, 2018
Funding/Support: Congressionally Directed Medical Research Programs (W81XWH-14-2-0128; to PG).
Conflict of Interest Disclosure: PG and RH have a financial interest in the BrainPort Vision Pro. The sponsor participated in study design, analysis and interpretation. The authors were responsible for preparation of this manuscript and the decision to submit this article for publication. Each of the authors had full access to the study data and take full responsibility for their presentation in this article.
Author Contributions and Acknowledgments: Conceptualization: PG, RH, JS, WS; Data Curation: PG; Formal Analysis: PG, WS; Funding Acquisition: PG, RH; Investigation: PG, MM, TA, JS, WS; Methodology: PG, RH, JS, WS; Project Administration: PG, MM, TA, RH, JS, WS; Resources: PG; Software: RH; Supervision: PG, RH, JS, WS; Validation: RH; Visualization: PG, RH; Writing – Original Draft: PG, WS; Writing – Review & Editing: MM, RH, JS, WS.
ClinicalTrials.gov Registry: First Posted: March 19, 2015, Identifier: NCT02393118.