Alternating Current Stimulation for Optic Neuropathy

Recruiting in Palo Alto (17 mi)

Overseen byJoseph Panarelli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

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).

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

I am 18 years old or older.

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

Clear optical apparatus

+6 more

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

+21 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS)Experimental Treatment1 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.