Actively Recruiting
An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
Led by NYU Langone Health · Updated on 2026-02-27
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and feasibility of a home-based treatment called repetitive transorbital alternating current stimulation (rtACS) to help people with optic neuropathy, a condition causing visual impairment. The study aims to see if this therapy can improve vision and functional independence by slowing or reversing vision loss related to the optic nerve and visual pathways. This open-label study is sponsored by NYU Langone Health and focuses on adults with confirmed optic neuropathy who have specific visual field defects and visual acuity levels. Participants will receive a total of 30 stimulation sessions using the SAVIR Alpha Synch mobile device. The first two sessions will take place in the clinic, with the initial session occurring one day after the baseline visit and the second session 48 hours later. The remaining 28 sessions will be conducted at home every other day over an 8-week period. This home-based intervention is designed to be non-invasive and is intended to stimulate the visual system. During the study, participants will undergo several assessments including measurements of retinal nerve fiber layer thickness, optic nerve head cup-to-disc ratio, visual field scores, visual acuity, contrast sensitivity, and vision-related quality of life questionnaires. These will be evaluated at baseline, 1 week, 3 months, and 6 months post-intervention. Adherence to the treatment schedule will be tracked, and safety monitoring will take place throughout the study. The total participation includes the baseline visit, intervention period, post-intervention visit, and two follow-up visits.
CONDITIONS
Brief Title
Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age equal to or over 18 years old
- Must have a permanent residence
- Diagnosis of optic neuropathy
- Visual field defects present in at least one eye with MD 64 -3.00 dB and FL, FP, FN <33%
- Visual Field Index between 10% and 90%
- Clear optical apparatus
- Best-corrected visual acuity of 20/400 or better in at least one eye
- Commitment to comply with study procedures including 30 intervention sessions every other day over 8 weeks, baseline, post-intervention, and two follow-up visits
- If unable to perform intervention independently, a family member or caregiver must assist
You will not qualify if you...
- High intraocular pressure over 27 mmHg
- End-stage organ disease or medical condition causing vision loss such as diabetes or stroke
- Advanced or unstable retinal diseases
- Pathological nystagmus
- Acute conjunctivitis
- Photosensitivity to flickering lights
- Ocular or non-ocular surgery within 2 months prior to enrollment
- Electric or electronic implants like cardiac pacemakers
- Metallic implants in head or torso (except titanium screws and dental implants)
- Diagnosed epilepsy under medical treatment
- Autoimmune disease in acute stage
- Metastatic disease
- Certain mental or psychiatric conditions affecting study participation
- Chronic unstable medical conditions that may cause missed visits
- Addiction without at least one year of abstinence
- Uncontrolled systemic hypertension with BP >160/100 mmHg
- Pregnant, breastfeeding, or planning pregnancy
- Severe skin conditions near stimulation sites
- Unstable or clinically unstable intraocular pressure
- Complete blindness in both eyes
- Non-resected brain tumors
- Unstable diabetic retinopathy in study eye
- Optic neuropathies caused by brain tumors
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive repetitive transorbital alternating current stimulation using the SAVIR Alpha Synch mobile device. The first two sessions are administered in the office, followed by 28 at-home sessions every other day over 8 weeks.
2 in-office visits and 28 at-home sessions every other day
Duration - 6 months
Participants attend follow-up visits to assess changes in visual function and retinal measures after completing the stimulation sessions.
3 visits post-intervention at 1 week, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10022
Actively Recruiting
Research Team
A
Angeles Ramos, MD
M
Maria de los Angeles Ramos, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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