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

Trial Summary

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 data supports the effectiveness of the treatment SAVIR Alpha Synch mobile (SASm) for optic neuropathy?

Research shows that alternating current stimulation (ACS) can improve vision in patients with optic nerve damage by enhancing brain activity and promoting recovery of visual functions. Studies suggest that this non-invasive treatment helps the brain's natural ability to adapt and recover, offering a promising option for those with optic neuropathy. ^{1 2 3 4 5}

Is alternating current stimulation safe for humans?

The research on alternating current stimulation (ACS) for optic neuropathy suggests it is generally safe for humans, as it is described as non-invasive and has been used in clinical trials without reported safety issues. ^{1 2 6 7 8}

How is the treatment SAVIR Alpha Synch mobile (SASm) different from other treatments 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 by leveraging the brain's ability to adapt and recover visual functions. This approach is unique because it stimulates the visual system without surgery or medication, aiming to restore vision by enhancing the brain's plasticity. ^{2 3 4 5 9}

What is the purpose of this trial?

The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current stimulation (rtACS) for the treatment of visual impairment in people with optic neuropathy. The primary aims are to evaluate the effectiveness of home-based rtACS to ameliorate the progressive effects of vision loss functionally in the eye and the visual pathway, and in regard to people's independence (i.e., functional ability).

Research Team

Joseph Panarelli, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Clear optical apparatus

Must have a permanent residence

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Non-invasive alternating current stimulation improves vision in optic neuropathy. [2013]

3. Japan pubmed.ncbi.nlm.nih.gov

Effect of transcorneal electrical stimulation in patients with nonarteritic ischemic optic neuropathy or traumatic optic neuropathy. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Vision modulation, plasticity and restoration using non-invasive brain stimulation - An IFCN-sponsored review. [2021]

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

Effectiveness of Microcurrent Stimulation in Preserving Retinal Function of Blind Leading Retinal Degeneration and Optic Neuropathy: A Systematic Review. [2022]

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

Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. [2018]

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

Transcorneal alternating current stimulation induces EEG "aftereffects" only in rats with an intact visual system but not after severe optic nerve damage. [2012]

8. Japan pubmed.ncbi.nlm.nih.gov

Effects of steroid administration and transcorneal electrical stimulation on the anatomic and electrophysiologic deterioration of nonarteritic ischemic optic neuropathy in a rodent model. [2021]

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

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