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

Illinois Institute of Technology

Status

Unknown

Conditions

Optic Nerve Diseases

Blindness,Acquired

Photoreceptor Degeneration

Ocular Injury

Treatments

Device: WFMA - wireless floating microelectrode array

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04634383

UH3NS095557 (U.S. NIH Grant/Contract)

ICVP0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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 ideation.
Poor decision-making capacity.
Current diagnosis or history of severe mental illness.
Women who are pregnant or plan on becoming pregnant in the duration of the trial.
Hand Motion (HM) vision or better vision,
No Light Perception (NLP) or Light Perception (LP) vision with present OptoKinetic Nystagmus (OKN)
NLP vision with pupil constriction
Patients with Islands of perceivable vision in Goldmann Visual Field or Confrontational visual Field will also be excluded from the study.
Patients with Complete media opacity (complete cornea opacity, very dense cataract) that does not allow visualization of the posterior segment to determine the cause of blindness will be excluded from the study. Only patients with NLP and LP vision without OKN will be included in the study.
Patients with NLP or LP vision since birth will also be excluded from the study, as they may not have fully developed higher visual pathways, including cortical connections