Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Last updated: April 8, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Treatment

SAVIR Alpha Synch mobile (SASm)

Clinical Study ID

NCT06662448
24-01043
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 2follow-up visits (2 days per visit).

  9. Scheduling

  10. Testing

  11. A subject deemed incapable of performing the study intervention independently due tovisual impairment or any other condition that may prevent them from performing theintervention accurately require a family member or caregiver to assist in performingthe intervention.

Exclusion

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 implantsare 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 wouldaffect the subject's ability to perform all necessary study tasks

  14. Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that maycause 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 forat 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, asthis device has not been tested on pregnant women and there is no data on usingrtACS for this particular group

  18. Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or otherskin defect which compromise the integrity of the skin at or near stimulationlocations

  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

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: SAVIR Alpha Synch mobile (SASm)
Phase:
Study Start date:
November 18, 2024
Estimated Completion Date:
May 18, 2029

Connect with a study center

  • NYU Langone Health

    New York, New York 10022
    United States

    Active - Recruiting

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