A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness (NCT04634383) | Clinical Trial Compass
UnknownNot Applicable
A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness
United States5 participantsStarted 2020-08-20
Plain-language 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.
Who can participate
Age range19 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ideati…
What they're measuring
1
To test the safety of the WFMA-based cortical interface.
Timeframe: From two-weeks post-op to end of device use, up to 3 years.