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

NCT ID: NCT01488786

Last Updated: 2013-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

BrainPort Vision Device

Single Arm

Group Type: EXPERIMENTAL

BrainPort Vision Device

Intervention Type: DEVICE

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

Interventions

BrainPort Vision Device

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wicab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimee Arnoldussen

Role: STUDY_DIRECTOR

Wicab, Inc.

William Seiple

Role: PRINCIPAL_INVESTIGATOR

Lighthouse International

Locations

Independence for the Blind of West Florida Inc.

Pensacola, Florida, United States

The Chicago Lighthouse for People Who Are Blind and Visually Impaired

Chicago, Illinois, United States

Envision

Wichita, Kansas, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Lighthouse International

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Canadian National Institute for the Blind

Toronto, , Canada

Countries

United States; Canada

Other Identifiers

WCB1-010

Identifier Type: -

Identifier Source: org_study_id