Development of a Cortical Visual Neuroprosthesis for the Blind (CORTIVIS)
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|ClinicalTrials.gov Identifier: NCT02983370|
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Blindness||Procedure: Minicraniotomy||Not Applicable|
Visual impairment is one of the ten most prevalent disabilities and poses extraordinary challenges to individuals in our society, which is heavily dependent on sight. Drug development and genetic engineering have had only marginal success as possible treatments but new hope has been generated by recent advances in neuroscience, micro-fabrication technologies, biomaterials, neuromorphic engineering and information and communication technologies leading to the development of highly sophisticated neural prosthetic devices which interact with the nervous system. Such assistive devices have already allowed thousands of deaf patients to hear sounds and acquire language abilities and the same hope exists in the field of visual rehabilitation.
Several research groups worldwide are engaged in attempts to restore vision through retinal prosthesis. However these devices are not viable for all causes of blindness. Thus, if the communication link between eye and brain is destroyed (e.g. for Glaucoma or optic nerve atrophy), as is the case for 148 million people worldwide, then visual cortical prosthesis holds the dominant hope for visual restoration. Consequently, there are many compelling reasons to pursue the development of a cortical prosthesis capable of restoring some useful vision in profoundly blind patients and this approach may be the only treatment available for end-stage retinitis pigmentosa patients and for pathologies such as glaucoma optic atrophy, trauma to the retina and/or optic nerves, and for diseases of the central visual pathways due to brain injuries or stroke.
The investigators will implant the CORTIVIS vision neuroprosthetic system, which utilizes a FDA cleared microelectrode array, into blind human volunteers and obtain descriptive feedback about visualized percepts. The experiments are designed to learn if volunteers can learn to integrate the electrical stimulation of brain visual areas into meaningful percepts. It is expected that a cortical device can create truly meaningful visual percepts that can be translated into functional gains such as the recognition, localization and grasping of objects or skillful navigation in familiar an unfamiliar environments resulting in a substantial improvement in the standard of living of blind and visually impaired persons.
All the experiments will be carried out at the patient's hospital room (Hospital IMED Elche) during the post-surgical period or in a human psychophysical laboratory (University Miguel Hernández).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||May 2024|
Experimental: Blind volunteer
Blind volunteers will be implanted with our existing vision neuroprosthetic system, which utilizes a FDA cleared microelectrode array, using a minicraniotomy. The array will be implanted near the occipital pole or in extra striate areas. The investigators will collect descriptive feedback regarding thresholds, evoked perceptions and stimulation parameters leading to recognizable patterns.
The surgical method for the implantation of the intracortical microelectrodes is straightforward and follows the standard neurosurgical procedures. Briefly, after the scalp is prepped with an antiseptic, a small skin incision is made. Then the skin and muscles are lifted off from the bone and folded back. Next, one small burr hole or a minicraniotomy of approximately 1.5 cm is made in the skull. This is a minimally invasive procedure that allows an easy access to the brain and is a standard procedure widely used in neurosurgery.
- Thresholds of visual perceptions elicited by intracortical microstimulation [ Time Frame: Within implantation period (up to 6 months) ]Charges needed for eliciting visual perceptions through electrical stimulation of the human cortex
- Phosphene mapping [ Time Frame: Within implantation period (up to 6 months) ]Location of induced perceptions within the visual field by pointing with the finger where the phosphene is perceived
- Visual Acuity [ Time Frame: Within implantation period (up to 6 months) ]Spatial resolution measured by computerized visual tests
- Motion perception [ Time Frame: Within implantation period (up to 6 months) ]Correct perception of movement with a coarse pattern moving in one of four directions
- Visual function [ Time Frame: Within implantation period (up to 6 months) ]Effectiveness of intracortical microstimulation to recognize letters, habitual objects and complex stimulation patterrns as measured by a suite of visual function tests. Questionnaire.
- Number of participants with significant adverse events. [ Time Frame: Within implantation period (up to 6 months) ]Complications and adverse events will be assessed through participant description of any possible adverse event, neurological examination, clinical tests and a specific questionnaire.
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): NCT02983370
|Contact: Eduardo Fernandez, MD and PhD||+34 firstname.lastname@example.org|
|Hospital IMED Elche||Recruiting|
|Elche, Alicante, Spain, 03202|
|Contact: Eduardo Fernandez, MD and PhD +34965222001 email@example.com|
|Universidad Miguel Hernandez de Elche||Recruiting|
|Elche, Alicante, Spain, 03202|
|Contact: Eduardo Fernandez, MD and PhD +34 965222001 firstname.lastname@example.org|
|Principal Investigator:||Eduardo Fernandez, MD and PhD||Universidad Miguel Hernandez de Elche|