ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ocular Injury
- Sponsor
- Illinois Institute of Technology
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- To test the safety of the WFMA-based cortical interface.
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
The objective of this study is to test the safety of the ICVP system and the feasibility of eliciting visual percepts in response to electrical stimulation in persons with blindness. The electrical stimulation is provided by wireless floating microelectrode arrays (WFMAs) that are part of the ICVP system. The WFMAs are implanted in the visual cortex. Five participants will take part in the study and each participant will have multiple WFMA devices implanted in their visual cortex on one side of the brain. After recovery from surgery, participants will begin a series of tests to assess the ability of electrical stimulation to induce visual percepts and how these percepts may provide some measure of artificial vision. Weekly participant testing will occur over a period of one to three years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Willing and able to meet the time demands of the study with transportation assistance.
- •Willing to agree to audio and video recording, as specified in the pre-screening consent.
- •Motivated by altruism, willingness to participate in pioneering science.
- •Demonstrated support from spouse, family and/or friends.
- •High or average cognitive and spatial functioning.
- •Normal structural MRI.
Exclusion Criteria
- •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
- •A disease prognosis of living less than five years.
- •An implant which would prevent screening using MRI, or a pacemaker, or similar implant.
- •A history of seizures.
- •Current suicidal ideation.
- •Poor decision-making capacity.
- •Current diagnosis or history of severe mental illness.
Outcomes
Primary Outcomes
To test the safety of the WFMA-based cortical interface.
Time Frame: From two-weeks post-op to end of device use, up to 3 years.
Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.
Secondary Outcomes
- To test the efficacy of the WFMA-based cortical interface(From four-weeks post-op to end of device use, up to 3 years.)