- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488786
A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
August 6, 2013 updated by: Wicab
A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Toronto, Canada, M4G 3E8
- Canadian National Institute for the Blind
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Florida
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Pensacola, Florida, United States, 32503
- Independence for the Blind of West Florida Inc.
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Illinois
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Chicago, Illinois, United States, 60608
- The Chicago Lighthouse for People Who Are Blind and Visually Impaired
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Kansas
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Wichita, Kansas, United States, 67203
- Envision
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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New York
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New York, New York, United States, 10022
- Lighthouse International
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: BrainPort Vision Device
Single Arm
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2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 1 year
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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%.
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1 year
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Object Recognition
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Word Identification
Time Frame: 1 year
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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.
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1 year
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Ambulation/Mobility
Time Frame: 1 year
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Another secondary efficacy objective is to demonstrate at least 35% of subjects demonstrate sign recognition in a mobility task.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aimee Arnoldussen, Wicab, Inc.
- Principal Investigator: William Seiple, Lighthouse International
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
December 6, 2011
First Submitted That Met QC Criteria
December 7, 2011
First Posted (ESTIMATE)
December 8, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 6, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCB1-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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