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

NCT ID: NCT04634383

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2023-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

WFMA Cortical Visual Prosthesis Single-arm Study

The WFMA is an electronic device that is implanted in the cortical vision processing regions of the brain to produce artificial vision.

Group Type: EXPERIMENTAL

WFMA - wireless floating microelectrode array

Intervention Type: DEVICE

Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ICVP System; ICVP; Intracortical Visual Prosthesis

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.
• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

The Chicago Lighthouse

OTHER

Sponsor Role: collaborator

The University of Texas at Dallas

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Illinois Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip R Troyk, PhD

Role: PRINCIPAL_INVESTIGATOR

Illinois Institute of Technology

Locations

Illinois Institue of Technology

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Recruitment Director

Role: CONTACT

ICVP@iit.edu

312-567-5304

Facility Contacts

Principal Investigator

Role: primary

ICVP@iit.edu

312-567-5304

References

Bak M, Girvin JP, Hambrecht FT, Kufta CV, Loeb GE, Schmidt EM. Visual sensations produced by intracortical microstimulation of the human occipital cortex. Med Biol Eng Comput. 1990 May;28(3):257-9. doi: 10.1007/BF02442682. No abstract available.

Reference Type: BACKGROUND

PMID: 2377008 (View on PubMed)

Schmidt EM, Bak MJ, Hambrecht FT, Kufta CV, O'Rourke DK, Vallabhanath P. Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. Brain. 1996 Apr;119 ( Pt 2):507-22. doi: 10.1093/brain/119.2.507.

Reference Type: BACKGROUND

PMID: 8800945 (View on PubMed)

Stephan K, Troyk PR, Dagnelie G, Cogan S, Barry MP, Grant P, Lane F, Szlyk JP, McNulty M, van Drongelen W, Pham TH, Stipp KL, Royster M, Towle VL. The Role of Scalp EEG Recordings During Cortical Visual Prosthesis Testing. Artif Organs. 2025 May 27:10.1111/aor.15023. doi: 10.1111/aor.15023. Online ahead of print.

Reference Type: DERIVED

PMID: 40421717 (View on PubMed)

Other Identifiers

UH3NS095557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ICVP0001

Identifier Type: -

Identifier Source: org_study_id