Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

NCT ID: NCT06662448

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2029-05-18

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SAVIR Alpha Synch mobile (SASm)

Intervention Type: 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.

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Panarelli, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph Panarelli, MD

Role: CONTACT

Joseph.Panarelli@nyulangone.org

212-263-2573

Maria de los Angeles Ramos, MD

Role: CONTACT

Angeles.Ramos@nyulangone.org

929-455-5047

Other Identifiers

24-01043

Identifier Type: -

Identifier Source: org_study_id