Optic Nerve Stimulation for Preventing Visual Deficits

Overseen By Ezequiel Goldschmidt, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Visual impairments, Prior cranial surgeries, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to monitor the optic nerve's health during brain surgeries near the eyes. By applying gentle electrical stimulation to the optic nerve, doctors aim to better track its function during surgery. The goal is to prevent unexpected vision problems. This trial suits patients with specific brain tumors, such as meningiomas or pituitary adenomas, who require surgery through the nose or skull and do not already have vision issues. As an unphased trial, it offers patients the chance to contribute to innovative research that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this optic nerve stimulation is safe?

Research shows that stimulating the optic nerve is generally safe for patients. Previous studies have used electrical stimulation to improve vision in people with various eye conditions, and this method has shown promise without causing major side effects.

In one study, patients with glaucoma (an eye disease that can lead to vision loss) tolerated electrical optic nerve stimulation well over time. The results did not show any serious negative effects, suggesting that this treatment is well-tolerated.

Moreover, the technology used for optic nerve stimulation is already employed in operating rooms, demonstrating a safety record in similar situations. This existing use supports its safety during surgeries that monitor optic nerve function.

Overall, while the treatment appears safe based on current data, discussing any concerns with a medical professional before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about optic nerve stimulation because it offers a novel approach to preventing visual deficits by directly engaging the optic nerve during surgery. Unlike standard treatments that focus on post-surgical care to address visual issues, this technique involves anterograde microstimulation during the procedure itself, which could potentially safeguard vision in real-time. This method has a distinct advantage as it allows for continuous monitoring of neural responses, providing immediate feedback that could help surgeons adjust their techniques to minimize damage. By targeting the optic nerve and chiasm during surgery, this approach could lead to more effective and immediate protection against visual deficits, a promising development in neurological and ophthalmological care.

What evidence suggests that optic nerve stimulation is effective for preventing visual deficits?

Research has shown that electrical stimulation, such as optic nerve stimulation, can improve vision in individuals with various eye disorders. Noninvasive electrical stimulation of the eye may help preserve or restore vision. Past studies demonstrated that tiny electrical currents protect patients with optic nerve issues. In this trial, some participants will receive optic nerve stimulation during surgery to help doctors monitor the optic nerve more effectively. The goal is to prevent vision problems post-surgery by closely observing the nerve. Overall, evidence suggests that optic nerve stimulation holds promise for maintaining vision during and after surgeries. ^{1 2 4 6 7}

Who Is on the Research Team?

Ezequiel Goldschmidt, MD, PhD

Principal Investigator

UCSF Department of Neurological Surgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing surgery for skull base or pituitary tumors that may affect the optic nerve. Participants must be able to undergo pre- and post-operative visual evaluations.

Inclusion Criteria

I will undergo a surgery through my nose.

I have been diagnosed with a tumor in the brain region near the pituitary gland.

I do not have any lasting or temporary vision loss.

Exclusion Criteria

I have had brain surgery or radiation therapy on my head.

I am able to understand and consent to my treatment.

My tumor is not in the sellar region and I need urgent surgery due to serious complications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Intraoperative Monitoring

Participants undergo endoscopic or open cranial approaches with optic nerve stimulation and monitoring

During surgery

1 visit (in-person)

Post-operative Evaluation

Participants receive post-operative visual evaluations to assess visual field and acuity

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optic Nerve Stimulation

Trial Overview The study tests a new way to monitor the optic nerve during surgery by stimulating it and recording responses. This could provide real-time, accurate assessments of nerve function to prevent damage.

How Is the Trial Designed?

Group I: Optic Nerve Stimulation Experimental Treatment 1 Intervention

The most significant procedure will be using an anterograde microstimulator and provoke stimulations to the optic nerve as the surgery proceeds. During surgery, the optic nerve and chiasm will be stimulated and the response recorded in both eyes and occipital cortex via skin electrodes. These responses will be monitored at all times by the neuromonitorig team who will inform if changes in neural responses change. The use of microstimulator has been proven safe in other surgical approaches.

Group II: No Intervention Active Control 1 Intervention

Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Noninvasive repetitive transorbital alternating current stimulation (rtACS) significantly improved detection ability in the visual field of patients with optic nerve damage, with a 41.1% increase compared to only 13.6% in the sham group, indicating its efficacy in vision restoration.

Patients receiving rtACS also reported greater improvements in vision-related quality of life, particularly in the 'general vision' subscale of the NEI-VFQ, suggesting that while visual field changes are important, other factors also influence overall quality of life related to vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy. Gall, C., Sgorzaly, S., Schmidt, S., et al.[2022]

Non-invasive stimulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial electrical stimulation (tDCS/tACS), have shown promise in modulating visual processing and restoring visual functions in patients with conditions like glaucoma and amblyopia, based on a review of their effects on both normal and damaged visual systems.

While these stimulation methods have demonstrated better responses than sham treatments in clinical studies, the variability in patient responses highlights the need for further research to understand their mechanisms of action and to personalize treatment protocols for improved efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision modulation, plasticity and restoration using non-invasive brain stimulation - An IFCN-sponsored review. Sabel, BA., Thut, G., Haueisen, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06495580

Optic Nerve Stimulation To Prevent Visual Deficits After ... The investigators predict that this novel approach will lead to improved intraoperative monitoring and better correlation with post- surgical clinical outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5225285/

Electrical Stimulation as a Means for Improving Vision - PMC Noninvasive electrical stimulation (ES) of the eye may be a promising therapy for either preserving or restoring vision in several retinal and optic nerve ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06495580

Optic Nerve Stimulation To Prevent Visual Deficits After ... Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715921062309

Review Article Effectiveness of Microcurrent Stimulation in ... A robust body of evidence revealed promising protective effects of TcES in RP patients and rtACS in optic neuropathy, while limited evidence was available for ...

5. withpower.com withpower.com/trial/phase-skull-base-neoplasms-7-2024-e4d76

Optic Nerve Stimulation for Preventing Visual Deficits Research shows that electrical stimulation, including optic nerve stimulation, can improve visual functions in patients with various vision disorders. For ...

6. ophthalmologytimes.com ophthalmologytimes.com/view/exploring-electrical-stimulation-therapy-a-promising-approach-to-vision-loss-in-optic-neuropathies

A promising approach to vision loss in optic neuropathies Electrical stimulation therapy is being explored as a potential treatment to enhance neuroplasticity and improve visual function in optic neuropathy patients.

7. bioelecmed.biomedcentral.com bioelecmed.biomedcentral.com/articles/10.1186/s42234-022-00089-9

Electrical neurostimulation in glaucoma with progressive ... The retrospective study provides real-world evidence for long-term clinical efficacy of electrical optic nerve stimulation (ONS) in glaucoma with progressive ...