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Neurostimulator

Brain Implants for Blindness

N/A
Waitlist Available
Led By Ausaf Bari, MPH
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is blind (i.e. bare light perception or no light perception in both eyes)
Subject resides within 2 hours distance (by ground transportation) of the investigational site
Must not have
Implantation of the investigational device would present unacceptable risk
Subject requires or is likely to require any of the following medical procedures while implanted with the NeuroPace RNS System: MR imaging, diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS). These medical procedures are contraindicated for patients with an implanted RNS® System. Energy from these procedures can be sent through the implanted brain stimulation system and cause permanent brain damage which may cause severe injury, coma, or death. Brain damage can occur from any of the listed procedures even if the RNS® Neurostimulator is turned off or if the Leads are not connected to the Neurostimulator, and can occur even if the Neurostimulator has been removed and any Leads (or any part of a Lead) or the cranial prosthesis remain. Refer to the Contraindications section of the RNS System User Manual for further details
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the use of a neurostimulator system called the NeuroPace RNS System to stimulate the visual cortex. The NeuroPace RNS System is a safe and reliable device that

Who is the study for?
This trial is for blind individuals aged 18-74 who once had useful vision, live within 2 hours of the study site, can attend regular appointments, and are medically fit for brain surgery. Women must use reliable contraception or be post-menopausal.
What is being tested?
The study tests a neurostimulator implant in the visual cortex using an FDA-approved device originally for epilepsy. It aims to find where to implant it, how much energy is needed for vision stimulation, and what kind of vision results.
What are the potential side effects?
While not specified here, typical side effects from similar procedures may include discomfort at the implant site, risk of infection, headache or dizziness post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am legally blind in both eyes.
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I live within 2 hours by car from the research site.
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I am between 18 and 74 years old.
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I am legally blind in both eyes.
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I live within 2 hours by car from the research center.
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I am between 18 and 74 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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Implanting the device in me is considered too risky.
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I cannot undergo MRI, diathermy, ECT, or TMS with my NeuroPace RNS System.
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I have chronic pain that is not managed well.
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I am blind due to damage to my brain's vision area.
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I have been diagnosed with moderate or severe depression.
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I am eligible for a commercial vision restoration treatment.
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I am at high risk for surgery complications due to infection, bleeding disorders, or low platelet count.
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I am on long-term blood thinners or have abnormal blood clotting tests.
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I have had brain surgery before.
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I do not have any severe health issues like uncontrolled high blood pressure or diabetes that would make it unsafe for me to participate.
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I have a history of bleeding problems or a weak immune system.
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I have a brain condition that prevents safe brain surgery.
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I have a history of seizures or epilepsy.
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I have Parkinson's disease.
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My brain or spinal cord disease is getting worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterization of stimulation-induced visions
Spatial localization of stimulation to produce visual phenomena with direct cortical stimulation.
Stimulation level required to elicit visual phosphene

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects will be implanted to assess the feasibility of stimulating visual cortex to restore vision in blind volunteers.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,266,995 Total Patients Enrolled
Ausaf Bari, MPHPrincipal InvestigatorUniversity of California, Los Angeles
Nader Pouratian, MD PhDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
~1 spots leftby Dec 2025
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