A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness (ICVP)
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|ClinicalTrials.gov Identifier: NCT04634383|
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : January 11, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Ocular Injury Optic Nerve Diseases Photoreceptor Degeneration Blindness,Acquired||Device: WFMA - wireless floating microelectrode array||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|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|
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.
- 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.
- 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.
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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|
- 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.
- 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
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
|Contact: Recruitment Director||312-567-5304||ICVP@iit.edu|
|United States, Illinois|
|Illinois Institue of Technology||Recruiting|
|Chicago, Illinois, United States, 60616|
|Contact: Principal Investigator 312-567-5304 ICVP@iit.edu|
|Principal Investigator:||Philip R Troyk, PhD||Illinois Institute of Technology|
|Responsible Party:||Illinois Institute of Technology|
|Other Study ID Numbers:||
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|
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.|
|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|
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases