Brain Implants for Blindness

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Epilepsy, Parkinson's, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people who are blind using a brain implant called the NeuroPace RNS System. The researchers aim to identify the optimal placement for the implant in the brain's visual area, determine the necessary energy to help create vision, and understand the type of vision it might produce. Individuals who are completely blind but previously had normal vision and live within two hours of the study site may qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could redefine vision restoration.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking chronic anticoagulants or antiplatelet agents. It's best to discuss your specific medications with the trial team.

What prior data suggests that this device is safe for use in the visual cortex?

Research has shown that the NeuroPace RNS System is safe to use. The FDA approved it in 2013 for treating epilepsy. Studies indicate that it is well-tolerated and safe over time. For instance, a study on stimulating the visual cortex found no serious side effects over 19 months, meaning participants experienced no major negative effects. Overall, the system has a proven safety and reliability record, making it a promising option for research into restoring vision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for blindness, such as visual aids or surgeries, focus on enhancing or repairing existing eye function. However, the NeuroPace RNS System is unique because it targets the brain directly, specifically the visual cortex, to restore vision. This approach involves implanting a device that stimulates the brain, bypassing damaged or non-functional parts of the eyes. Researchers are excited about this treatment because it opens up the possibility of restoring vision in individuals who have lost it due to severe eye damage or diseases, offering hope where traditional methods have limited success.

What evidence suggests that the NeuroPace RNS System is effective for stimulating the visual cortex in blindness?

Research has shown that the NeuroPace RNS System is both effective and safe for treating epilepsy, with studies finding it can reduce seizures by up to 53% after two years of use. The system sends signals to the brain's surface to help control unusual activity. Initially approved for epilepsy, this trial will implant the system in participants to assess its feasibility in stimulating the visual cortex, the part of the brain responsible for vision. The aim is to determine if it can help restore vision in people who are blind. Although this is a new application, the device is already known to be safe and reliable. ^{1 6 7 8 9}

Who Is on the Research Team?

Ausaf Bari, MPH

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I live within 2 hours by car from the research site.

I am a man, or I am a woman using birth control/not pregnant/post-menopausal.

I am healthy enough for brain surgery.

Exclusion Criteria

Implanting the device in me is considered too risky.

My preoperative brain MRI shows a significant abnormality.

Subject is pregnant or planning on becoming pregnant in the next year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Assessment

Subjects will be implanted with the NeuroPace RNS System to assess the feasibility of stimulating the visual cortex

4-6 weeks

Stimulation and Evaluation

Determine the stimulation level required to elicit visual phosphene and characterize stimulation-induced visions

6 months

Follow-up

Participants are monitored for safety and effectiveness after stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NeuroPace RNS System

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects will be implanted to assess the feasibility of stimulating visual cortex to restore vision in blind volunteers.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1. neuropace.com neuropace.com/wp-content/uploads/2021/02/blinded-evaluation-rns-system.pdf

Responsive Cortical Stimulation for the Treatment of ... Treatment with the RNS® System resulted in a 41.5% reduction in disabling seizures by the end of the blinded period, compared to a 9.4%reduction in.

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000010154

Nine-year prospective efficacy and safety of brain- ... This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.

3. neuropace.com neuropace.com/wp-content/uploads/2021/02/neuropace-rns-system-clinical-summary.pdf

RNS System Clinical Summary ABOUT THIS MANUAL. This manual is intended to provide information about the Clinical Studies conducted on the NeuroPace®. RNS® System.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4233950/

Final results of the RNS System Pivotal trial - PMC Note that all subjects were receiving responsive stimulation during the OLP. The median percent reduction at 1 year was 44% and at 2 years was 53% compared to ...

5. neuropace.com neuropace.com/wp-content/uploads/2021/02/rns-system-real-world-outcomes-long-term-treatment-study.pdf

rns-system-real-world-outcomes-long-term-treatment-study ... Two large multi-center studies demonstrate safety and effectiveness of the RNS System. • The Long-Term Treatment (LTT)1 study (n=230) prospectively evaluated ...

6. neuropace.com neuropace.com/wp-content/uploads/2021/01/neuropace-rns-system-patient-selection-guide.pdf

RNS® System Patient Selection The RNS® System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset.

7. neuropace.com neuropace.com/providers/rns-system-safety-data/

RNS System | Proven Safety Profile Responsive neurostimulation was well tolerated and safe over time. Conclusions from 9 years of data in the largest prospective neuromodulation study in the ...

8. clinicaltrial.be clinicaltrial.be/en/details/10279?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Feasibility of Stimulating the Visual Cortex in Blind - C... The NeuroPace RNS System has a proven record of safety and reliability was approved by the FDA in November 2013. The RNS System is indicated for ...

9. thejns.org thejns.org/view/journals/j-neurosurg/132/6/article-p2000.xml

Phosphene perceptions and safety of chronic visual cortex ... The authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events.