Recruiting

rtACS

Sponsor:

NYU Langone Health

Code:

NCT06662448

Conditions

Optic Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SAVIR Alpha Synch mobile (SASm)

Study Details

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).

Conditions

Optic Neuropathy

Study ID

NCT06662448

Start date

Nov 18, 2024

Status verified date

Feb, 2026

Completion date

May 18, 2029

Anticipated

Primary completion date

May 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

SAVIR Alpha Synch mobile (SASm)

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.

Primary outcome measure

  • Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [ Time Frame: baseline, 1 week post-intervention ]
  • Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [ Time Frame: baseline, 3 months post-intervention ]
  • Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [ Time Frame: baseline, 6 months post-intervention ]
  • Change in macular ganglion cell-inner plexiform layer thickness (µm) [ Time Frame: baseline, 1 week post-intervention ]
  • Change in macular ganglion cell-inner plexiform layer thickness (µm) [ Time Frame: baseline, 3 months post-intervention ]
  • Change in macular ganglion cell-inner plexiform layer thickness (µm) [ Time Frame: baseline, 6 months post-intervention ]
  • Change in optic nerve (ON) head cup-to-disc ratio (%) [ Time Frame: baseline, 1 week post-intervention ]
  • Change in optic nerve (ON) head cup-to-disc ratio (%) [ Time Frame: baseline, 3 months post-intervention ]
  • Change in optic nerve (ON) head cup-to-disc ratio (%) [ Time Frame: baseline, 6 months post-intervention ]
  • Change in Humphrey Visual Field Analyzer (HFA) score [ Time Frame: baseline, 1 week post-intervention ]
  • Change in Humphrey Visual Field Analyzer (HFA) score [ Time Frame: baseline, 3 months post-intervention ]
  • Change in Humphrey Visual Field Analyzer (HFA) score [ Time Frame: baseline, 6 months post-intervention ]
  • Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score [ Time Frame: baseline, 1 week post-intervention ]
  • Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score [ Time Frame: baseline, 3 months post-intervention ]
  • Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score [ Time Frame: baseline, 6 months post-intervention ]
  • Change in Pelli-Robson score [ Time Frame: baseline, 1 week post-intervention ]
  • Change in Pelli-Robson score [ Time Frame: baseline, 3 months post-intervention ]
  • Change in Pelli-Robson score [ Time Frame: baseline, 6 months post-intervention ]
  • Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score [ Time Frame: baseline, 1 week post-intervention ]
  • Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score [ Time Frame: baseline, 3 months post-intervention ]
  • Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score [ Time Frame: baseline, 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10022

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-27.