NCT02983370 Development of a Cortical Visual Neuroprosthesis for the Blind
| NCT ID | NCT02983370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Miguel Hernandez de Elche |
| Condition | Blindness |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2019-10-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Eduardo Fernandez, MD and PhD
PRINCIPAL INVESTIGATOR
Universidad Miguel Hernandez de Elche
Frequently Asked Questions
Who can join the NCT02983370 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Blindness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02983370 currently recruiting?
Yes, NCT02983370 is actively recruiting participants. Contact the research team at e.fernandez@umh.es for enrollment information.
Where is the NCT02983370 trial being conducted?
This trial is being conducted at Elche, Spain, Elche, Spain.
Who is sponsoring the NCT02983370 clinical trial?
NCT02983370 is sponsored by Universidad Miguel Hernandez de Elche. The principal investigator is Eduardo Fernandez, MD and PhD at Universidad Miguel Hernandez de Elche. The trial plans to enroll 5 participants.