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
|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.
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|