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

5 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment NeuroPace RNS System for blindness?

The research on visual prostheses shows that devices using electrical stimulation can provide some level of artificial vision to people with acquired blindness. Although the NeuroPace RNS System is not specifically mentioned, similar technologies have shown progress in restoring basic visual functions by stimulating parts of the visual pathway. ^{1 2 3 4 5}

Is the NeuroPace RNS System safe for use in humans?

In a study using the NeuroPace RNS System for visual cortex stimulation in a blind individual, no serious adverse events were observed over 19 months. The participant experienced only mild headaches and dizziness on a few occasions, which did not last long and required no medical treatment. ^{3 5 6 7 8}

How does the NeuroPace RNS System treatment for blindness differ from other treatments?

The NeuroPace RNS System is unique because it involves brain implants that directly stimulate the visual cortex, unlike other treatments that focus on the retina or optic nerve. This approach aims to restore vision by creating artificial visual perceptions through electrical stimulation, which is different from traditional methods that rely on the remaining healthy parts of the eye. ^{3 9 10 11 12}

What is the purpose of this trial?

In this study, the investigators intend to evaluate the use of a commercially available neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. 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 use in patients with epilepsy and includes a skull implanted neurostimulator. No modification to the RNS System is required for this study. This study will use this device to better understand the effect of stimulation on the visual parts of the brain. The main purposes of this study are to confirm the desired location to implant a device in the visual cortex, determine the amount of energy needed to elicit vision, and assess the nature of the vision that is produced. This information is important to have early in the process of designing a visual cortical prosthesis that could eventually be used for commercial use.

Research Team

Ausaf Bari, MPH

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Total eye transplantation for the blind: a challenge for the future. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

An implantable microsystem as a vision prosthesis. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Contemporary approaches to visual prostheses. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Progress in the clinical development and utilization of vision prostheses: an update. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Update on retinal prosthetic research: the Boston Retinal Implant Project. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Retinal implants: a systematic review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The potential of the second sight system bionic eye implant for partial sight restoration. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Shape perception via a high-channel-count neuroprosthesis in monkey visual cortex. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Visual prostheses]. [2018]

11. Belgium pubmed.ncbi.nlm.nih.gov

[Perspectives in the rehabilitation of vision in blind subjects]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Prosthetic interfaces with the visual system: biological issues. [2021]