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

Blindness Clinical Trial

Official title:

A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488786
• Other study ID #: WCB1-010
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: August 6, 2013
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Wicab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blindness

Intervention

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

Locations

Country	Name	City	State
Canada	Canadian National Institute for the Blind	Toronto
United States	The Chicago Lighthouse for People Who Are Blind and Visually Impaired	Chicago	Illinois
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Lighthouse International	New York	New York
United States	Independence for the Blind of West Florida Inc.	Pensacola	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Envision	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Wicab

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	Word Identification	A secondary efficacy objective is to demonstrate that at least 50% of subjects correctly identify at least 50% of a series of three- to five-letter words.	1 year	No
Secondary	Ambulation/Mobility	Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.	1 year	No