RecruitingNot Applicable

A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness

United States5 participantsStarted 2020-08-20

Plain-language 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.

Who can participate

Age range

19 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * English as preferred language. * Normal decision-making capacity. 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 ideati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To test the safety of the WFMA-based cortical interface.

Timeframe: From two-weeks post-op to end of device use, up to 3 years.

Trial details

NCT IDNCT04634383

SponsorIllinois Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Recruitment Director

312-567-5304 ICVP@illinoistech.edu

View on ClinicalTrials.gov More Ocular Injury trials