A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind

NCT01488786 | Completed DMC

• 1 other identifier: WCB1-010
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 7

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.

Conditions

Blindness

Keywords

Assistive Technology; Non-Surgical Visual Prosthetic; Sensory Substitution

Outcome Measures

Primary Outcomes (2)

• Safety

  The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%.

  1 year

• Object Recognition

  The primary efficacy objective is to demonstrate that at least 50% of subjects achieve a success rate in object recognition exceeding that expected by chance alone.

  1 year

Secondary Outcomes (2)

• Word Identification

  1 year

• Ambulation/Mobility

  1 year

Study Arms (1)

BrainPort Vision Device

EXPERIMENTAL

Single Arm

Device: BrainPort Vision Device

Interventions

BrainPort Vision Device DEVICE

2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.

BrainPort Vision Device

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wicab: lead

Study Sites (7)

Independence for the Blind of West Florida Inc.

Pensacola, Florida, 32503, United States

Location

The Chicago Lighthouse for People Who Are Blind and Visually Impaired

Chicago, Illinois, 60608, United States

Location

Envision

Wichita, Kansas, 67203, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Lighthouse International

New York, New York, 10022, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Canadian National Institute for the Blind

Toronto, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aimee Arnoldussen

  Wicab, Inc.

  STUDY DIRECTOR

• William Seiple

  Lighthouse International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

CA (1); US (6)