Development of a Cortical Visual Neuroprosthesis for the Blind (CORTIVIS)
Blindness
About this trial
This is an interventional other trial for Blindness
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.
Sites / Locations
- Hospital IMED ElcheRecruiting
- Universidad Miguel Hernandez de ElcheRecruiting
Arms of the Study
Arm 1
Experimental
Blind volunteer
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.