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Prosthetic Device

BrainPort V200 Device for Blindness

N/A
Waitlist Available
Led By Patricia Grant, M.S.
Research Sponsored by Wicab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

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).

Eligible Conditions
  • Blindness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
To assess the safety of electrical stimulation on the tongue (to demonstrate no occurrence of a clinically significant device-related adverse event)
Other outcome measures
Change in perceived general pain after using the device for one year as measured by the Universal Pain Assessment Tool
Change in satisfaction of the device after using the device for one year, as measured by the Device Satisfaction Survey
Change in self-efficacy after using the device for one year as measured by the General Self-Efficacy Scale (GSES)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: BrainPort V200 DeviceExperimental Treatment1 Intervention
Single Arm

Find a Location

Who is running the clinical trial?

Lighthouse GuildOTHER
1 Previous Clinical Trials
106 Total Patients Enrolled
WicabLead Sponsor
5 Previous Clinical Trials
436 Total Patients Enrolled
2 Trials studying Blindness
200 Patients Enrolled for Blindness
The Chicago LighthouseOTHER
2 Previous Clinical Trials
305 Total Patients Enrolled
1 Trials studying Blindness
5 Patients Enrolled for Blindness

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury
2014. "A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02393118.
All > Vision
~2 spots leftby Apr 2025
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