Clinical Trial: Development of a Cortical Visual Neuroprosthesis for the Blind

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Visual impairment is one of the ten most prevalent disabilities and poses extraordinary challenges to individuals in our society, which is heavily dependent on sight. Drug development and genetic engineering have had only marginal success as possible treatments but new hope has been generated by recent advances in neuroscience, micro-fabrication technologies, biomaterials, neuromorphic engineering and information and communication technologies leading to the development of highly sophisticated neural prosthetic devices which interact with the nervous system. Such assistive devices have already allowed thousands of deaf patients to hear sounds and acquire language abilities and the same hope exists in the field of visual rehabilitation.

Several research groups worldwide are engaged in attempts to restore vision through retinal prosthesis. However these devices are not viable for all causes of blindness. Thus, if the communication link between eye and brain is destroyed (e.g. for Glaucoma or optic nerve atrophy), as is the case for 148 million people worldwide, then visual cortical prosthesis holds the dominant hope for visual restoration. Consequently, there are many compelling reasons to pursue the development of a cortical prosthesis capable of restoring some useful vision in profoundly blind patients and this approach may be the only treatment available for end-stage retinitis pigmentosa patients and for pathologies such as glaucoma optic atrophy, trauma to the retina and/or optic nerves, and for diseases of the central visual pathways due to brain injuries or stroke.

The investigators will implant the CORTIVIS vision neuroprosthetic system, which utilizes a FDA cleared microelectrode array, into blind human volunteers and obtain descriptive feedback about visualized percepts. The experiments are designed to learn if vol
Sponsor: Universidad Miguel Hernandez de Elche

Current Primary Outcome: Thresholds of visual perceptions elicited by intracortical microstimulation [ Time Frame: Within implantation period (3 months) ]

Charges needed for eliciting visual perceptions through electrical stimulation of the human cortex


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Phosphene mapping [ Time Frame: Within implantation period (3 months) ]
    Location of induced perceptions within the visual field by pointing with the finger where the phosphene is perceived
  • Visual Acuity [ Time Frame: Within implantation period (3 months) ]
    Spatial resolution measured by computerized visual tests
  • Motion perception [ Time Frame: Within implantation period (3 months) ]
    Correct perception of movement with a coarse pattern moving in one of four directions
  • Visual function [ Time Frame: Within implantation period (3 months) ]
    Effectiveness of intracortical microstimulation to recognize letters, habitual objects and complex stimulation patterrns as measured by a suite of visual function tests. Questionnaire.
  • Number of participants with significant adverse events. [ Time Frame: Within implantation period (3 months) ]
    Complications and adverse events will be assessed through participant description of any possible adverse event, neurological examination, clinical tests and a specific questionnaire.


Original Secondary Outcome: Same as current

Information By: Universidad Miguel Hernandez de Elche

Dates:
Date Received: September 12, 2016
Date Started: September 2016
Date Completion: June 2018
Last Updated: December 1, 2016
Last Verified: December 2016