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โ† Trials
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Development of a Cortical Visual Neuroprosthesis for the Blind

RecruitingNAAges 18 Years - 70 YearsAllUniversidad Miguel Hernandez de Elche
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Minicraniotomy
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Where

2 sites
Hospital IMED Elche
Elche, Spain
Universidad Miguel Hernandez de Elche
Elche, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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