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Recruiting NCT06662448

Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Trial Parameters

Condition Optic Neuropathy
Sponsor NYU Langone Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-18
Completion 2029-05-18
Interventions
SAVIR Alpha Synch mobile (SASm)

Brief Summary

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

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

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