NCT04634383

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

ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Illinois Institute of Technology · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Injury
• Optic Nerve Diseases
• Photoreceptor Degeneration
• Blindness,Acquired

Interventions

Type	Name	Description
DEVICE	WFMA - wireless floating microelectrode array	Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.

Timeline

• Start date: 2020-08-20
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2020-11-18
• Last updated: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study