Alternating Current Stimulation for Optic Neuropathy

Overseen By Maria de los Angeles Ramos, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antiepileptics, Antipsychotics

Disqualifiers: Diabetes, Stroke, Epilepsy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home-based treatment called repetitive transorbital alternating current stimulation (rtACS) to improve vision in people with optic neuropathy, a condition that damages the optic nerve and affects sight. The researchers aim to determine if this treatment can slow or improve vision loss and enhance independence in daily activities. Participants will use a device called SAVIR Alpha Synch mobile (SASm) for 30 sessions over eight weeks. Individuals with optic neuropathy who have some vision impairment in at least one eye and can commit to the study schedule may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance daily life for those with vision impairment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, certain medical conditions and treatments, like epilepsy on medical treatment or uncontrolled diabetes, may affect eligibility.

What prior data suggests that this protocol is safe for treating optic neuropathy?

Studies have shown that repetitive transorbital alternating current stimulation (rtACS) is a non-invasive method with potential to improve vision. This treatment applies gentle electrical currents around the eyes. Research suggests that most people find it safe and well-tolerated, with few side effects, though individual experiences can differ. Prospective trial participants should discuss any concerns with the study team, who can provide more information based on specific situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for optic neuropathy, which often include medications or surgery, SAVIR Alpha Synch mobile (SASm) offers a novel approach by using Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS). This treatment is unique because it involves the non-invasive application of alternating current directly to the optic nerves, potentially enhancing neural activity and promoting recovery. Researchers are excited about this method as it allows patients to complete the majority of the sessions conveniently at home, which could improve adherence and accessibility while providing a new avenue of hope for visual improvement.

What evidence suggests that this protocol is effective for optic neuropathy?

Research has shown that repetitive transorbital alternating current stimulation (rtACS), which participants in this trial will receive, can improve vision in people with optic nerve damage. Early results suggest that this gentle, non-invasive technique uses mild electrical currents around the eye area to potentially enhance vision. Studies have found that patients using this method noticed improvements in their vision-related quality of life. While more research is needed to fully understand its effectiveness, early tests are promising. This method could offer a new way to manage vision loss for those with optic nerve problems. ^{2 3 5 6 7}

Who Is on the Research Team?

Joseph Panarelli, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with optic neuropathy, a condition affecting the eye nerves. Participants should be willing to undergo home-based treatment involving repetitive electrical stimulation (rtACS) aimed at improving vision and independence.

Inclusion Criteria

Must have a permanent residence

VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN <33%

Clear optical apparatus

Exclusion Criteria

Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed)

I have a brain tumor that has not been surgically removed.

Pregnant or breast-feeding women or women that are planning to become pregnant, as this device has not been tested on pregnant women and there is no data on using rtACS for this particular group

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 30 stimulation sessions of home-based repetitive transorbital alternating current stimulation (rtACS), with the first two sessions in-office and the remaining 28 at-home over 8 weeks

8 weeks

2 visits (in-person), 28 sessions (at-home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• SAVIR Alpha Synch mobile (SASm)

Trial Overview The study tests the SAVIR Alpha Synch mobile (SASm), which delivers rtACS to see if it can help reduce vision loss in people with optic neuropathy. It's an open-label study, meaning everyone knows they're getting the actual treatment.

How Is the Trial Designed?

Group I: Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS) Experimental Treatment 1 Intervention

Participants will undergo 30 stimulation sessions. The first two sessions will be administered in the office, the first one the day after the subjects' baseline visit and the second one 48 hours after the first intervention. Then subjects will conduct 28 at-home intervention sessions taking place every other day over the course of 8 weeks.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study involving 18 patients with optic nerve damage, repetitive transorbital alternating current stimulation (rtACS) over 10 days significantly increased alpha brain wave activity, suggesting that rtACS can enhance rhythmic brain activity.

Visual field improvements were observed after rtACS treatment, indicating potential therapeutic benefits for patients with visual deficits, although these improvements were not directly linked to changes in alpha-synchronization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive enhancement of alpha activity and visual function in patients with optic neuropathy: a two-week repeated session alternating current stimulation study. Schmidt, S., Mante, A., Rönnefarth, M., 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]

Transcranial alternating current stimulation (tACS) at 1 microampere significantly altered the responsiveness of On-center retinal ganglion cells in rabbits, affecting their light-evoked responses for up to several hours after stimulation.

The study found that tACS differentially influenced the initial and sustained responses to light, suggesting potential implications for enhancing visual processing and contrast sensitivity without directly causing significant firing changes in the cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tACS-Like Electrical Stimulation on On-Center Retinal Ganglion Cells: Part I. Amthor, FR., Strang, CE.[2022]

In a study involving 82 patients with optic nerve damage, repetitive transorbital alternating current stimulation (rtACS) significantly improved visual fields by an average of 24% compared to only 2.5% improvement in the sham group, with effects lasting at least 2 months.

The improvement in visual fields was linked to changes in brain activity, suggesting that rtACS may enhance brain plasticity, making it a promising and safe treatment option for restoring partial vision after optic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. Gall, C., Schmidt, S., Schittkowski, MP., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06662448?term=synch&viewType=Table&rank=7

Repetitive Transorbital Alternating Current Stimulation for ... The SAVIR Alpha Synch mobile is a device first used in office and then intended to be used for the home therapy of the visual system with non-invasive ...

2. withpower.com withpower.com/trial/phase-optic-nerve-diseases-10-2024-f880e

Alternating Current Stimulation for Optic Neuropathy The SAVIR Alpha Synch mobile (SASm) treatment uses non-invasive alternating current stimulation (ACS) to help improve vision in patients with optic neuropathy ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06662448/repetitive-transorbital-alternating-current-stimulation-for-optic-neuropathies

Repetitive Transorbital Alternating Current Stimulation for ... The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current ...

4. ctv.veeva.com ctv.veeva.com/study/an-open-label-study-using-rtacs-for-optic-neuropathies

Repetitive Transorbital Alternating Current Stimulation for ... The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11584570/

Transorbital Alternating Current Stimulation in a Double ... To determine the efficacy and safety of repetitive transorbital alternating current stimulation (rtACS) treatment by assessing vision-related quality of life ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06662448?cond=%22Optic%20Nerve%20Diseases%22&aggFilters=status:not%20rec&rank=6

Repetitive Transorbital Alternating Current Stimulation for ... The SAVIR Alpha Synch mobile is a device first used in office and then intended to be used for the home therapy of the visual system with non-invasive ...

7. withpower.com withpower.com/trial/phase-glaucoma-open-angle-2023-a2855

Electrical Stimulation for Glaucoma (rtACS Trial) What safety data exists for electrical stimulation treatment for glaucoma? The study titled 'Noninvasive transorbital alternating current stimulation improves ...