A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorIllinois Institute of Technology
About this trial
The purpose of this study is to determine the feasibility of producing artificial vision in persons with blindness. Study participants will have wireless electrical stimulators implanted into the cortical vision processing areas of their brains. The ability of the participants to perceive artificial vision in response to electrical stimulation will be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No light perception or bare light perception, in each eye in accordance with relevant International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, where the physician has no expectation of improvement through currently approved treatments.
History of normal or near-normal vision, with or without refractive correction, during at least the first 10 years of life.
Adjusted to blindness for at least one year.
History of vision or blindness rehabilitation.
Disqualifiers
Poor adjustment to blindness, or vision loss within the last year.
Expectation of vision restoration to pre-blindness level through trial participation.
History of alcohol or drug dependence.
Evidence of prior immune response to an orthopedic implant which caused the implant to be explanted
Trial design
Design model
Single group
Treatments tested in this trial
WFMA - wireless floating microelectrode array
DeviceWirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: WFMA Cortical Visual Prosthesis Single-arm StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To test the safety of the WFMA-based cortical interface.
Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.
Time frame
From two-weeks post-op to end of device use, up to 3 years.Secondary outcomes
1
To test the efficacy of the WFMA-based cortical interface
Efficacy is defined as establishing a chronic intracortical interface for which the ability to elicit visual percepts in response to electrical stimulation can be demonstrated with stimulus intensities of 16 nanocoulombs per phase or less.
Time frame
From four-weeks post-op to end of device use, up to 3 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Illinois Institute of Technology
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Rush University Medical Center
Collaborator
The Chicago Lighthouse
Collaborator
The University of Texas at Dallas
Collaborator
University of Chicago
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov