Clinical trial NCT01488786: A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
Official title: A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blindness
Keywords: Assistive Technology
Non-Surgical Visual Prosthetic
Sensory Substitution
Lead sponsor: Wicab
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.


Eligibility criteria: Inclusion Criteria:

* Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception
* Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure.
* Minimum post 6 months diagnosis blindness.
* Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
* Able to have read to him or her, understand, and sign the informed consent form.
* Daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred.
* Willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device.

Exclusion Criteria:

* Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator.
* Any medical condition that would interfere with performance on the assessments.
* Prior use of the BrainPort vision device.
* Known neuropathies of tongue or skin tactile system.
* Smoke or chew tobacco products less than 12 months prior to study enrollment
* Any allergies to nickel or stainless steel
* History of seizures or epilepsy.
* If female, pregnant. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
* People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant).
* Psychiatric disease including anxiety disorders and forms of depression (using provided Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI- II) as screening tools).
* Any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following:
* Cognitive decline including forms of dementia and/or progressive neurological disease
* Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
* Does not speak English
* Blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc)
* Principal Investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.

Primary outcomes:
measure: Safety
timeFrame: 1 year
measure: Object Recognition
timeFrame: 1 year
Secondary outcomes:
measure: Word Identification
timeFrame: 1 year
measure: Ambulation/Mobility
timeFrame: 1 year
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Independence for the Blind of West Florida Inc.
state: Florida
city: Chicago
country: United States
facility: The Chicago Lighthouse for People Who Are Blind and Visually Impaired
state: Illinois
city: Wichita
country: United States
facility: Envision
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New York
country: United States
facility: Lighthouse International
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Toronto
country: Canada
facility: Canadian National Institute for the Blind
Study officials:
affiliation: Wicab, Inc.
name: Aimee Arnoldussen
role: STUDY_DIRECTOR
affiliation: Lighthouse International
name: William Seiple
role: PRINCIPAL_INVESTIGATOR
References: