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CORTIVISPilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes

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What is being tested

Minicraniotomy

Procedure
Who is being recruted

Blindness+5

+ Eye Diseases

+ Nervous System Diseases

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: October 2019
See protocol details

Summary

Principal SponsorUniversidad Miguel Hernandez de Elche
Study ContactEduardo Fernandez, MD and PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2019

Actual date on which the first participant was enrolled.

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).

Official TitlePilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes
NCT02983370
Principal SponsorUniversidad Miguel Hernandez de Elche
Study ContactEduardo Fernandez, MD and PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BlindnessEye DiseasesNervous System DiseasesNeurologic ManifestationsSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVision Disorders

Criteria

Inclusion Criteria: * Participant is capable and willing to provide informed consent for participation in the trial. * Severe visual impairment with bilateral visual loss. * Greater than 18 years of age. * General health: excellent. * Following a general physical and neurological examination, patient must have normal serum electrolytes, C-reactive protein, complete blood count and PT and PTT. * No history of stroke, seizure, coagulopathy, cardiac arrhythmias or ischemia, pulmonary, hepatic or renal disease, nor transmissible viruses such as hepatitis or HIV. * Stable dose of current regular medication for at least four weeks prior to trial entry. * Able to perform the study during the full time period of up to 6 months. Special consideration will be given to patients with (1) detailed medical histories, including documentation of the onset, mechanism and evolution of the blindness; (2) lower risks associated with surgery; and (3) no psychiatric disorders or other mental disabilities. Exclusion Criteria: * Age \<18 or \>70. * Period of appropriate visual functions \< 12 years /lifetime. * For medical reasons: Individuals with a history of seizure disorders, coagulopathy, cardiac arrythmias or ischemia, pulmonary, hepatic or renal disease, and any other neurological disorder. Patients who carry a transmissible virus such as hepatitis and individuals with HIV-related neuropathies. * Vulnerable subject groups (e.g., pregnant women, prisoners, etc.). * Persons unable to give written informed consent prior to participation in the study. * Not able to perform the study during the full time period (at least 3 months). * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Hospital IMED Elche

Elche, SpainOpen Hospital IMED Elche in Google Maps
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Universidad Miguel Hernandez de Elche

Elche, Spain
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2 Study Centers