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Recruiting Not applicable

Development of a Cortical Visual Neuroprosthesis for the Blind

NCT02983370 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2019-10-01
Last updated
2026-05-05

Condition(s) studied

Blindness

Investigational drug(s) / intervention(s)

Minicraniotomy

Minicraniotomy: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Thresholds of visual perceptions elicited by intracortical microstimulation — Within implantation period (up to 6 months)
    Charges needed for eliciting visual perceptions through electrical stimulation of the human cortex

Trial sites (2)

FacilityCityRegionStatus
Hospital IMED Elche Elche Alicante Recruiting
Universidad Miguel Hernandez de Elche Elche Alicante Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02983370 on ClinicalTrials.gov ↗ ← All trials in Spain