← Back to Search

Device

Alternating Current Stimulation for Optic Neuropathy

N/A

Waitlist Available

Led By Joseph Panarelli, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age equal to or over 18 years old

Diagnosis of optic neuropathy

Must not have

Non-resected brain tumors

Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or other skin defect which compromise the integrity of the skin at or near stimulation locations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new treatment using repetitive transorbital alternating current stimulation at home for people with visual impairment due to optic neuropathy. The main goal is to see if this treatment can improve

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of rtACS may include discomfort at the stimulation site, headache, or temporary visual disturbances. However, specific side effects will depend on individual responses to the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with optic neuropathy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I do not have severe skin conditions near stimulation areas.

Select...

My blood pressure has never been over 160/100 mmHg.

Select...

My cancer has spread to other parts of my body.

Select...

My diabetes has caused unstable vision problems in one eye.

Select...

I have vision problems due to a brain tumor.

Select...

I am unable to give consent by myself.

Select...

My eye condition is stable and not severe.

Select...

I have lost vision due to a serious health condition like diabetes or stroke.

Select...

I have pink eye.

Select...

I have been diagnosed with involuntary eye movements.

Select...

I have an active autoimmune disease like rheumatoid arthritis.

Select...

My mental health allows me to participate fully in all study activities.

Select...

I am being treated for epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score

Change in Humphrey Visual Field Analyzer (HFA) score

Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 16Eligibility criteria met