RecruitingNot ApplicableNCT02983370

Development of a Cortical Visual Neuroprosthesis for the Blind

Pilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes

Sponsor

Universidad Miguel Hernandez de Elche

Enrollment

5 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Blindness

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

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 Criteria7

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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Interventions

PROCEDUREMinicraniotomy

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.