Development of a Cortical Visual Neuroprosthesis for the Blind
ConditionBlindness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversidad Miguel Hernandez de Elche
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Design model
Single group
Treatments tested in this trial
Minicraniotomy
Procedure/SurgeryThe 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Blind volunteerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Thresholds of visual perceptions elicited by intracortical microstimulation
Charges needed for eliciting visual perceptions through electrical stimulation of the human cortex
Time frame
Within implantation period (up to 6 months)Secondary outcomes
1
Phosphene mapping
Location of induced perceptions within the visual field by pointing with the finger where the phosphene is perceived
Time frame
Within implantation period (up to 6 months)2
Visual Acuity
Spatial resolution measured by computerized visual tests
Time frame
Within implantation period (up to 6 months)3
Motion perception
Correct perception of movement with a coarse pattern moving in one of four directions
Time frame
Within implantation period (up to 6 months)4
Visual function
Effectiveness of intracortical microstimulation to recognize letters, habitual objects and complex stimulation patterrns as measured by a suite of visual function tests. Questionnaire.
Time frame
Within implantation period (up to 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Miguel Hernandez de Elche
Lead sponsor
Hospital IMED Elche
Collaborator
Source ClinicalTrials.gov