Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06662448
Status
Recruiting
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Conditions

  • Optic Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SAVIR Alpha Synch mobile (SASm) — DEVICE
    The SAVIR Alpha Synch mobile is a device first used in office and then intended to be used for the home therapy of the visual system with non-invasive electrical stimulation.

Study Details

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).

Key Dates

Start date
Nov 18, 2024
Status verified
Feb 2026
Primary completion
May 18, 2029
Completion
May 18, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS)
    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.

Primary Outcome Measure

Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [ Time Frame: baseline, 1 week post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10022-

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By research site
NYU Langone Health· New York, NY

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