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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wicab
ClinicalTrials.gov Identifier:
NCT01488786
First received: December 6, 2011
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Blindness
Device: BrainPort Vision Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind

Further study details as provided by Wicab:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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%.

  • Object Recognition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Word Identification [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Ambulation/Mobility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.


Enrollment: 75
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BrainPort Vision Device
Single Arm
Device: BrainPort Vision Device
2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488786

Locations
United States, Florida
Independence for the Blind of West Florida Inc.
Pensacola, Florida, United States, 32503
United States, Illinois
The Chicago Lighthouse for People Who Are Blind and Visually Impaired
Chicago, Illinois, United States, 60608
United States, Kansas
Envision
Wichita, Kansas, United States, 67203
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Lighthouse International
New York, New York, United States, 10022
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Canada
Canadian National Institute for the Blind
Toronto, Canada, M4G 3E8
Sponsors and Collaborators
Wicab
Investigators
Study Director: Aimee Arnoldussen Wicab, Inc.
Principal Investigator: William Seiple Lighthouse International
  More Information

No publications provided

Responsible Party: Wicab
ClinicalTrials.gov Identifier: NCT01488786     History of Changes
Other Study ID Numbers: WCB1-010
Study First Received: December 6, 2011
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wicab:
Assistive Technology
Non-Surgical Visual Prosthetic
Sensory Substitution

ClinicalTrials.gov processed this record on September 18, 2014