NCT06662448 Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
| NCT ID | NCT06662448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Optic Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2029-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-11-18 with a primary completion date of 2029-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Jonathan Williams, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06662448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Optic Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06662448 currently recruiting?
Yes, NCT06662448 is actively recruiting participants. Contact the research team at angeles.ramos@nyulangone.org for enrollment information.
Where is the NCT06662448 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06662448 clinical trial?
NCT06662448 is sponsored by NYU Langone Health. The principal investigator is Jonathan Williams, MD at NYU Langone Health. The trial plans to enroll 70 participants.