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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Optic Nerve Diseases; Ocular Injury; Photoreceptor Degeneration; Blindness,Acquired
• Intervention / Treatment: Device: WFMA - wireless floating microelectrode array

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Recruitment Director; Phone Number: 312-567-5304; Email: ICVP@iit.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Recruiting
      • Illinois Institue of Technology
      • Contact: Principal Investigator; Phone Number: 312-567-5304; Email: ICVP@iit.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: ICVP System; ICVP; Intracortical Visual Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test the safety of the WFMA-based cortical interface.	Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.	From two-weeks post-op to end of device use, up to 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test the efficacy of the WFMA-based cortical interface	Efficacy is defined as establishing a chronic intracortical interface for which the ability to elicit visual percepts in response to electrical stimulation can be demonstrated with stimulus intensities of 16 nanocoulombs per phase or less.	From four-weeks post-op to end of device use, up to 3 years.

Collaborators and Investigators

• Sponsor: Illinois Institute of Technology
• Collaborators: Johns Hopkins University; University of Chicago; National Institute of Neurological Disorders and Stroke (NINDS); Rush University Medical Center; The University of Texas at Dallas; The Chicago Lighthouse
• Investigators: Principal Investigator: Philip R Troyk, PhD, Illinois Institute of Technology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Electrical Stimulation; Blindness; Visual Prosthesis
• Additional Relevant MeSH Terms: Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Vision Disorders; Nervous System Diseases; Optic Nerve Diseases; Blindness
• Other Study ID Numbers: ICVP0001; UH3NS095557 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We may electively share de-identified study data with collaborators
• IPD Sharing Time Frame: Duration of the study
• IPD Sharing Access Criteria: Data required by study collaborators to perform analysis of safety and efficacy of the ICVP system.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes