Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Not Applicable

Recruiting

• Conditions: Optic Neuropathy

• Registration Number: NCT06662448
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-29
• Study Start: 2024-11-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2029-05-18
• Study Completion: 2029-05-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)	baseline, 6 months post-intervention	Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in macular ganglion cell-inner plexiform layer thickness (µm)	baseline, 6 months post-intervention	Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in optic nerve (ON) head cup-to-disc ratio (%)	baseline, 6 months post-intervention	Outcome measure will be assessed using Optical coherence tomography (OCT).
Change in Humphrey Visual Field Analyzer (HFA) score	baseline, 6 months post-intervention	The Humphrey Visual Field Analyzer (HFA) score is a numerical value that represents a patient's retinal sensitivity at specific points in the retina. The score is measured in decibels (dB), with higher numbers indicating higher sensitivity. A normal reading is around 30 dB, and values below this range may indicate a visual field defect. The dBs tested by the Humphrey analyzer range between 0 and 50 dB (0 is the brightest and 50 is the dimmest). A value of 0 means the patient could not see the brightest target, and a 50 means the dimmest target was seen.
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score	baseline, 6 months post-intervention	The ETDRS VA score is based on the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters. The final score is calculated by adding 30 to the total number of letters read correctly at 4 meters.Good VA is 20/20 to 20/50; intermediate VA is \<20/50 to 20/200; poor VA is \<20/200.
Change in Pelli-Robson score	baseline, 6 months post-intervention	The Pelli-Robson test is a wall-mounted chart with large letters arranged in triplets. The contrast decreases by 0.15 log units for each triplet. Patients are given credit for a contrast level if they answer two of the three letters in a triplet correctly. Each letter correctly identified is scored as 0.05 log units. The Pelli-Robson contrast sensitivity chart score range is 0.00-2.25 log contrast sensitivity. A score of 2.0 indicates normal contrast sensitivity, less than 1.5 indicates moderate reduction in contrast sensitivity, indicating some level of visual impairment, and less than 1.0 indicates visual disability.
Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score	baseline, 6 months post-intervention	The 39-item VFQ is designed to measure VRQoL. It is a frequently used measure of VRQoL in vision science research. The VFQ-39 is divided into 12 subscales: general health, general vision, ocular pain, near vision, distant vision, vision specific social functioning, vision-specific role difficulties, vision-specific mental health, vision-specific dependency, driving, peripheral vision, and color vision. Responses are rated on either Likert or dichotomous (yes/no) scales. The questionnaire is scored by converting the original numeric values from the survey to a 0 to 100 scale, with 100 being the best score and 0 being the worst.

Secondary Outcome Measures

Name	Time	Method
Number of participants' who adhered to the study protocol regimen	Month 6
Number of scheduled clinical appointments reviewed	Month 6
Number of patients considered potentially eligible as determined during review of the clinical appointment schedule	Month 6
Number of patients who are potentially eligible but express no interest in participating in the study	Month 6
Number of patients who are determined ineligible following screening procedures	Month 6

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States