5 Participants NeededMy employer runs this trial

Intracortical Visual Prosthesis for Vision Loss

(ICVP Trial)

Recruiting at 1 trial location
RD
Overseen ByRecruitment Director
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Illinois Institute of Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special device can create artificial vision for individuals who are completely blind. Researchers implant the device, a wireless floating microelectrode array, in the brain's vision processing areas to assess its ability to help participants "see" through electrical signals. It targets those with no light perception in both eyes, who had normal vision for at least the first ten years of life, and who have adjusted to their blindness for at least a year.

As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could revolutionize vision restoration.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the WFMA device is safe for producing artificial vision?

Research has shown that the Wireless Floating Microelectrode Array (WFMA) is generally well-tolerated. Early studies with the first five participants found that patients accepted the device and successfully used it to see images without major issues.

Evidence also indicates that the WFMA can safely assist the brain in creating vision. It bypasses damaged parts of the eye and directly stimulates the visual cortex, the brain region responsible for sight. The technology uses specific frequencies and methods to ensure safety and avoid harming the brain.

Overall, findings suggest that the WFMA is safe for human use, with no major safety concerns reported in early studies. However, ongoing research will continue to closely monitor its safety, as with any new medical device.12345

Why are researchers excited about this trial?

Unlike other treatments for blindness that often rely on external devices or medications, the WFMA Cortical Visual Prosthesis is a game-changer because it involves directly implanting a wireless microelectrode array into the brain's vision processing areas. This innovative approach aims to create artificial vision by stimulating the brain's visual cortex, offering the potential for more natural and direct visual experiences. Researchers are excited about this treatment because it bypasses damaged optic nerves and eyes, directly interacting with the brain, which might provide vision possibilities that current therapies can't offer.

What evidence suggests that the WFMA device is effective for producing artificial vision in blindness?

Research has shown that the Wireless Floating Microelectrode Array (WFMA), which participants in this trial will receive, can help create artificial vision. Studies indicate that it bypasses damaged parts of the eye, such as the retina and optic nerves, and directly stimulates the brain's vision areas. Early results from the first five participants showed that the device was well tolerated and could create visual experiences. The WFMA uses wireless technology to connect with the brain, making it a promising tool for helping people with blindness see again. Overall, early findings are encouraging and suggest the device could restore a useful level of vision.12346

Who Is on the Research Team?

PR

Philip R Troyk, PhD

Principal Investigator

Illinois Institute of Technology

Are You a Good Fit for This Trial?

This trial is for adults who have lost almost all vision in both eyes (no or bare light perception) after having normal sight as a child, are well-adjusted to blindness for at least one year, and have good mental and cognitive health. People with some remaining vision, recent vision loss, certain medical conditions, or poor support cannot join.

Inclusion Criteria

You want to participate in the study because you want to help advance medical science.
You have people in your life who are willing and able to support you during the study.
You have good thinking and problem-solving abilities.
See 9 more

Exclusion Criteria

You have very dense cataracts or other eye problems that make it impossible to see the back of your eye to determine the cause of your blindness. Only people with very poor vision and no eye movement will be included in the study.
You have to be able to see at least well enough to detect movement with your hands.
Poor decision-making capacity.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Recovery

Participants undergo surgery to implant WFMA devices and recover post-operatively

4 weeks

Testing and Assessment

Weekly testing to assess the ability of electrical stimulation to induce visual percepts

1 to 3 years
Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after device use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • WFMA - wireless floating microelectrode array

Trial Overview

The study tests a new device called the wireless floating microelectrode array (WFMA), which is implanted into the brain's visual area to see if it can create artificial vision through electrical stimulation. This is an early-phase safety and feasibility study.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: WFMA Cortical Visual Prosthesis Single-arm StudyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Illinois Institute of Technology

Lead Sponsor

Trials
26
Recruited
15,300+

Rush University Medical Center

Collaborator

Trials
448
Recruited
247,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

The University of Texas at Dallas

Collaborator

Trials
71
Recruited
108,000+

The Chicago Lighthouse

Collaborator

Trials
3
Recruited
330+

Citations

First human implantation of the WFMA for intracortical ...

The WFMA is a core component of the Intracortical Visual Prosthesis (ICVP) system, which aims to bypass the retina and optic nerves of people with blindness and ...

Wireless Floating Microelectrode Array (WFMA)

The Floating Microelectrode Array allows stimulation and recording from the CNS and the periphery through a wireless link.

Researcher, Patient Guide Next Stage for a Wireless ...

The Wireless Floating Microelectrode Array attaches to the surface of the brain underneath the skull. Source: Intracortical Visual Prosthesis ( ...

Wireless microelectrode arrays for selective and chronically ...

Our research aims to develop a stable neural interface using wireless communication and intrafascicular microelectrodes to provide highly selective stimulation ...

Abstract Details

Conclusions This study establishes a reproducible image-based method for evaluating WFMA stability in individuals implanted with the ICVP system. Upon ...

The Current State of Cortical Visual Prosthetics - PMC - NIH

Cortical visual prosthetics have been shown to have the potential of restoring a useful degree of vision via stimulation of primary visual cortex.