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| Name | Class |
|---|---|
| Hospital IMED Elche | UNKNOWN |
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The objective of this study is to evaluate the usefulness of a cortical visual prosthesis based on intracortical microelectrodes to provide a limited but useful sense of vision to profoundly blind. This pilot study will provide important information on safety and efficacy for the development of an useful cortical visual neuroprosthesis for the blind.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blind volunteer | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minicraniotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Thresholds of visual perceptions elicited by intracortical microstimulation | Charges needed for eliciting visual perceptions through electrical stimulation of the human cortex | Within implantation period (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphene mapping | Location of induced perceptions within the visual field by pointing with the finger where the phosphene is perceived | Within implantation period (up to 6 months) |
| Visual Acuity |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Fernandez, MD and PhD | Contact | +34 965222001 | e.fernandez@umh.es |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo Fernandez, MD and PhD | Universidad Miguel Hernandez de Elche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital IMED Elche | Recruiting | Elche | Alicante | 03202 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27354187 | Background | Martinez-Alvarez A, Crespo-Cano R, Diaz-Tahoces A, Cuenca-Asensi S, Ferrandez Vicente JM, Fernandez E. Automatic Tuning of a Retina Model for a Cortical Visual Neuroprosthesis Using a Multi-Objective Optimization Genetic Algorithm. Int J Neural Syst. 2016 Nov;26(7):1650021. doi: 10.1142/S0129065716500210. Epub 2016 Mar 29. | |
| 25926778 |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
Spatial resolution measured by computerized visual tests
| Within implantation period (up to 6 months) |
| Motion perception | Correct perception of movement with a coarse pattern moving in one of four directions | Within implantation period (up to 6 months) |
| Visual function | Effectiveness of intracortical microstimulation to recognize letters, habitual objects and complex stimulation patterrns as measured by a suite of visual function tests. Questionnaire. | Within implantation period (up to 6 months) |
| Number of participants with significant adverse events. | Complications and adverse events will be assessed through participant description of any possible adverse event, neurological examination, clinical tests and a specific questionnaire. | Within implantation period (up to 6 months) |
| Universidad Miguel Hernandez de Elche | Recruiting | Elche | Alicante | 03202 | Spain |
|
| Alfaro A, Bernabeu A, Agullo C, Parra J, Fernandez E. Hearing colors: an example of brain plasticity. Front Syst Neurosci. 2015 Apr 14;9:56. doi: 10.3389/fnsys.2015.00056. eCollection 2015. |
| 25100989 | Background | Fernandez E, Greger B, House PA, Aranda I, Botella C, Albisua J, Soto-Sanchez C, Alfaro A, Normann RA. Acute human brain responses to intracortical microelectrode arrays: challenges and future prospects. Front Neuroeng. 2014 Jul 21;7:24. doi: 10.3389/fneng.2014.00024. eCollection 2014. |
| 19458403 | Background | Normann RA, Greger B, House P, Romero SF, Pelayo F, Fernandez E. Toward the development of a cortically based visual neuroprosthesis. J Neural Eng. 2009 Jun;6(3):035001. doi: 10.1088/1741-2560/6/3/035001. Epub 2009 May 20. |
| 11483297 | Background | Warren DJ, Fernandez E, Normann RA. High-resolution two-dimensional spatial mapping of cat striate cortex using a 100-microelectrode array. Neuroscience. 2001;105(1):19-31. doi: 10.1016/s0306-4522(01)00174-9. |
| 10788663 | Background | Maynard EM, Fernandez E, Normann RA. A technique to prevent dural adhesions to chronically implanted microelectrode arrays. J Neurosci Methods. 2000 Apr 15;97(2):93-101. doi: 10.1016/s0165-0270(00)00159-x. |
| 17011701 | Background | Morillas CA, Romero SF, Martinez A, Pelayo FJ, Ros E, Fernandez E. A design framework to model retinas. Biosystems. 2007 Feb;87(2-3):156-63. doi: 10.1016/j.biosystems.2006.09.009. Epub 2006 Sep 7. |
| 16317227 | Background | Fernandez E, Pelayo F, Romero S, Bongard M, Marin C, Alfaro A, Merabet L. Development of a cortical visual neuroprosthesis for the blind: the relevance of neuroplasticity. J Neural Eng. 2005 Dec;2(4):R1-12. doi: 10.1088/1741-2560/2/4/R01. Epub 2005 Nov 29. |
| 20577634 | Background | Marin C, Fernandez E. Biocompatibility of intracortical microelectrodes: current status and future prospects. Front Neuroeng. 2010 May 28;3:8. doi: 10.3389/fneng.2010.00008. eCollection 2010. |
| 19426816 | Background | Bernabeu A, Alfaro A, Garcia M, Fernandez E. Proton magnetic resonance spectroscopy (1H-MRS) reveals the presence of elevated myo-inositol in the occipital cortex of blind subjects. Neuroimage. 2009 Oct 1;47(4):1172-6. doi: 10.1016/j.neuroimage.2009.04.080. Epub 2009 May 5. |
| 27762237 | Background | Normann RA, Fernandez E. Clinical applications of penetrating neural interfaces and Utah Electrode Array technologies. J Neural Eng. 2016 Dec;13(6):061003. doi: 10.1088/1741-2560/13/6/061003. Epub 2016 Oct 20. |
| 34665780 | Background | Fernandez E, Alfaro A, Soto-Sanchez C, Gonzalez-Lopez P, Lozano AM, Pena S, Grima MD, Rodil A, Gomez B, Chen X, Roelfsema PR, Rolston JD, Davis TS, Normann RA. Visual percepts evoked with an intracortical 96-channel microelectrode array inserted in human occipital cortex. J Clin Invest. 2021 Dec 1;131(23):e151331. doi: 10.1172/JCI151331. |
| 40602416 | Result | Kucukoglu B, Soo L, Leeftink D, Grani F, Soto Sanchez C, Guclu U, van Gerven M, Fernandez E. Bayesian optimization of cortical neuroprosthetic vision using perceptual feedback. J Neural Eng. 2025 Jul 24;22(4). doi: 10.1088/1741-2552/adeae9. |
| 41788163 | Result | Alfaro A, Soo L, Waclawczyk D, Morollon R, Grani F, Fernandez E. The unexpected sight: improvement of visual function following intracortical microstimulation of the human occipital cortex. Brain Commun. 2026 Feb 3;8(1):fcaf504. doi: 10.1093/braincomms/fcaf504. eCollection 2026. |
| 41475513 | Result | Lozano A, Chen X, La Grouw M, Li B, Wang F, van der Grinten M, Soto-Sanchez C, Morales-Gregorio A, Fernandez E, Roelfsema PR. Large-scale mapping of artificial perceptions for neuroprostheses using spontaneous neuronal activity in macaque and human visual cortex. Brain Stimul. 2026 Jan-Feb;19(1):103019. doi: 10.1016/j.brs.2025.103019. Epub 2025 Dec 29. |
| 41191758 | Result | Grani F, Soto-Sanchez C, Rodil Doblado A, Lopez Peco R, Gonzalez-Lopez P, Fernandez E. Neural correlates of phosphene perception in blind individuals: A step toward a bidirectional cortical visual prosthesis. Sci Adv. 2025 Nov 7;11(45):eadv8846. doi: 10.1126/sciadv.adv8846. Epub 2025 Nov 5. |
| 40689721 | Result | Ruiz RM, Garces JAC, Soo L, Fernandez E. Enhancing Orientation and Mobility Assessments: Integrating Visual and Auditory Factors Using Artificial Intelligence Tools. Transl Vis Sci Technol. 2025 Jul 1;14(7):14. doi: 10.1167/tvst.14.7.14. |
| 41021945 | Result | Waclawczyk D, Soo L, Morollon Ruiz R, Caspi A, Fernandez E. Integrating Eye-Tracking With Cortical Visual Prostheses in Patients Without Eyes: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2025;33:3998-4007. doi: 10.1109/TNSRE.2025.3615286. |
| 40375639 | Result | Lopez-Peco R, Val-Calvo M, Soto-Sanchez C, Villamarin-Ortiz A, Ruiz-Boix G, Ferrandez-Vicente JM, Fernandez E. Neuronal Waveform Classification in Multielectrode Recordings Using Machine Learning Techniques and Multidimensional Analysis. Int J Neural Syst. 2025 Jun;35(6):2550031. doi: 10.1142/S0129065725500315. |
| 40173310 | Result | Farfan FD, Soo L, Grani F, Grima-Murcia MD, Fernandez E. Brain connectivity changes in response to cortical electrical stimulation in blind neuroprosthesis users. Cereb Cortex. 2025 Apr 1;35(4):bhaf075. doi: 10.1093/cercor/bhaf075. |
| 39446886 | Result | Fernandez E, Robles JA. Advances and challenges in the development of visual prostheses. PLoS Biol. 2024 Oct 24;22(10):e3002896. doi: 10.1371/journal.pbio.3002896. eCollection 2024 Oct. |
| 37890180 | Result | Rocca A, Lehner C, Wafula-Wekesa E, Luna E, Fernandez-Cornejo V, Abarca-Olivas J, Soto-Sanchez C, Fernandez-Jover E, Gonzalez-Lopez P. Robot-assisted implantation of a microelectrode array in the occipital lobe as a visual prosthesis: technical note. J Neurosurg. 2023 Oct 27;140(4):1169-1176. doi: 10.3171/2023.8.JNS23772. Print 2024 Apr 1. |
| 36582211 | Result | Grani F, Soto-Sanchez C, Fimia A, Fernandez E. Toward a personalized closed-loop stimulation of the visual cortex: Advances and challenges. Front Cell Neurosci. 2022 Dec 13;16:1034270. doi: 10.3389/fncel.2022.1034270. eCollection 2022. |
| 35817011 | Result | Grani F, Soto-Sanchez C, Farfan FD, Alfaro A, Grima MD, Rodil Doblado A, Fernandez E. Time stability and connectivity analysis with an intracortical 96-channel microelectrode array inserted in human visual cortex. J Neural Eng. 2022 Jul 22;19(4). doi: 10.1088/1741-2552/ac801d. |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |