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

Primary Purpose

Ocular Injury, Optic Nerve Diseases, Photoreceptor Degeneration

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

WFMA - wireless floating microelectrode array

About this trial

This is an interventional device feasibility trial for Ocular Injury focused on measuring Blindness, Visual Prosthesis, Electrical Stimulation

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Illinois Institue of TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WFMA Cortical Visual Prosthesis Single-arm Study

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04634383

First Posted

October 12, 2020

Last Updated

January 9, 2022

Sponsor

Illinois Institute of Technology

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

1. Study Identification

Unique Protocol Identification Number

NCT04634383

Brief Title

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

Acronym

ICVP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2020 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Illinois Institute of Technology

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Blindness, Visual Prosthesis, Electrical Stimulation

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WFMA Cortical Visual Prosthesis Single-arm Study

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

WFMA - wireless floating microelectrode array

Other Intervention Name(s)

ICVP System, ICVP, Intracortical Visual Prosthesis

Intervention Description

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

Primary Outcome Measure Information:

Title

To test the safety of the WFMA-based cortical interface.

Description

Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.

Time Frame

From two-weeks post-op to end of device use, up to 3 years.

Secondary Outcome Measure Information:

Title

To test the efficacy of the WFMA-based cortical interface

Description

Time Frame

From four-weeks post-op to end of device use, up to 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Recruitment Director

Phone

312-567-5304

ICVP@iit.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip R Troyk, PhD

Organizational Affiliation

Illinois Institute of Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Illinois Institue of Technology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Principal Investigator

Phone

312-567-5304

ICVP@iit.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

2377008

Citation

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.

Results Reference

background

PubMed Identifier

8800945

Citation

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.

Results Reference

background

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

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