Home-based electrical stimulation for optic neuropathy
Official title: An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
Run by NYU Langone Health · NCT06662448 · Data updated 2026-11-12
This study tests if a home treatment using electrical stimulation can help people with optic neuropathy improve their vision and daily activities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | May 18, 2029 |
| Study ends | May 18, 2029 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06662448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with optic neuropathy and experiencing specific visual field defects.
✕Probably not a fit
Patients with high intraocular pressure or those with end-stage organ disease causing vision loss may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the efficacy and feasibility of a home-based intervention using repetitive transorbital alternating current stimulation (rtACS) to treat visual impairment in individuals with optic neuropathy. Participants will undergo 30 sessions of rtACS over an 8-week period, with assessments of their visual function and independence before, during, and after the intervention. The study focuses on measuring improvements in vision loss and overall functional ability related to daily activities.
Why it matters
Potential benefit: If successful, this intervention could help improve vision and independence for patients suffering from optic neuropathy.
How similar studies have gone: While the approach of using rtACS is innovative, similar studies have not been widely reported, making this a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age equal to or over 18 years old 2. Must have a permanent residence 3. Diagnosis of optic neuropathy 4. VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN \<33% 5. Visual Field Index (VFI) 10-90% 6. Clear optical apparatus 7. Best-corrected VA of 20/400 or better in at least one eye 8. Commitment to comply with study procedures: 8-week period of intervention sessions (30 sessions every other day), baseline visit, post-intervention visit, and 2 follow-up visits (2 days per visit). 1. Scheduling 2. Testing 9. A subject deemed incapable of performing the study intervention independently due to visual impairment or any other condition that may prevent them from performing the intervention accurately require a family member or caregiver to assist in performing the intervention. Exclusion Criteria: 1. High intraocular pressure (over 27 mmHg) 2. End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke) 3. Advanced or unstable retinal diseases 4. Pathological nystagmus 5. Acute conjunctivitis 6. Photosensitivity to flickering lights 7. Non-ocular/ocular surgery within the previous 2 months to enrollment date 8. Electric or electronic implants (e.g., cardiac pacemaker) 9. Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed) 10. Diagnosed epilepsy on medical treatment 11. Auto-immune disease, acute stage (e.g., rheumatoid arthritis) 12. Metastatic disease 13. Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks 14. Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits 15. Addiction (e.g., drug/alcohol dependence) that has not been in abstinent control for at least one year 16. Uncontrolled systemic hypertension (historical BP \> 160/100 mmHg) 17. 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 18. 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 19. IOP that the principal investigator determines that is not clinically stable 20. Complete blindness of both eyes 21. Non-resected brain tumors 22. Unstable diabetic retinopathy in the study eye 23. Optic neuropathies secondary to brain tumors 24. Subjects without the capacity to consent
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Jonathan Williams, MD — NYU Langone Health
- Study coordinator: Angeles Ramos, MD
- Email: angeles.ramos@nyulangone.org
- Phone: 929-455-5047
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.