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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04634383
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Rush University Medical Center
The Chicago Lighthouse
The University of Texas at Dallas
University of Chicago
Johns Hopkins University
Information provided by (Responsible Party):
Illinois Institute of Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ocular Injury Optic Nerve Diseases Photoreceptor Degeneration Blindness,Acquired Device: WFMA - wireless floating microelectrode array Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible participants for the study will be persons with blindness who meet the listed inclusion criteria. Individuals having any of the listed exclusion criteria will not be eligible to participate in the study. Enrolled participants will receive electrical stimulation devices implanted in the cortical region of their brain that is involved in vision processing. A maximum of five participants will be implanted. Written Informed Consent will be obtained from all participants before they are enrolled in the study.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arms and Interventions
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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


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


Secondary Outcome Measures :
  1. To test the efficacy of the WFMA-based cortical interface [ Time Frame: From four-weeks post-op to end of device use, up to 3 years. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634383


Contacts
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Contact: Recruitment Director 312-567-5304 ICVP@iit.edu

Locations
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United States, Illinois
Illinois Institue of Technology Recruiting
Chicago, Illinois, United States, 60616
Contact: Principal Investigator    312-567-5304    ICVP@iit.edu   
Sponsors and Collaborators
Illinois Institute of Technology
National Institute of Neurological Disorders and Stroke (NINDS)
Rush University Medical Center
The Chicago Lighthouse
The University of Texas at Dallas
University of Chicago
Johns Hopkins University
Investigators
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Principal Investigator: Philip R Troyk, PhD Illinois Institute of Technology
More Information
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Publications:

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Responsible Party: Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT04634383    
Other Study ID Numbers: ICVP0001
UH3NS095557 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We may electively share de-identified study data with collaborators
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Duration of the study
Access Criteria: Data required by study collaborators to perform analysis of safety and efficacy of the ICVP system.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Illinois Institute of Technology:
Blindness
Visual Prosthesis
Electrical Stimulation
Additional relevant MeSH terms:
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Blindness
Nervous System Diseases
Optic Nerve Diseases
Vision Disorders
 Sensation Disorders
Neurologic Manifestations
Eye Diseases
Cranial Nerve Diseases