Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

NCT06662448 | Recruiting FDA Device

• 1 other identifier: 24-01043
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (21)

• Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 1 week post-intervention

• Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 3 months post-intervention

• Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 6 months post-intervention

• Change in macular ganglion cell-inner plexiform layer thickness (µm)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 1 week post-intervention

• Change in macular ganglion cell-inner plexiform layer thickness (µm)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 3 months post-intervention

• Change in macular ganglion cell-inner plexiform layer thickness (µm)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 6 months post-intervention

• Change in optic nerve (ON) head cup-to-disc ratio (%)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 1 week post-intervention

• Change in optic nerve (ON) head cup-to-disc ratio (%)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 3 months post-intervention

• Change in optic nerve (ON) head cup-to-disc ratio (%)

  Outcome measure will be assessed using Optical coherence tomography (OCT).

  baseline, 6 months post-intervention

• Change in Humphrey Visual Field Analyzer (HFA) score

  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.

  baseline, 1 week post-intervention

• Change in Humphrey Visual Field Analyzer (HFA) score

  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.

  baseline, 3 months post-intervention

• Change in Humphrey Visual Field Analyzer (HFA) score

  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.

  baseline, 6 months post-intervention

• Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score

  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.

  baseline, 1 week post-intervention

• Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score

  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.

  baseline, 3 months post-intervention

• Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) score

  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.

  baseline, 6 months post-intervention

• Change in Pelli-Robson score

  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.

  baseline, 1 week post-intervention

• Change in Pelli-Robson score

  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.

  baseline, 3 months post-intervention

• Change in Pelli-Robson score

  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.

  baseline, 6 months post-intervention

• Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score

  The 39-item VFQ is designed to measure vision-related quality of life (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.

  baseline, 1 week post-intervention

• Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score

  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.

  baseline, 3 months post-intervention

• Change in National Eye Institute Visual Functioning Questionnaire (VFQ-39) score

  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.

  baseline, 6 months post-intervention

Secondary Outcomes (5)

• 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

• Number of participants' who adhered to the study protocol regimen

  Month 6

Study Arms (1)

Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS)

EXPERIMENTAL

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.

Device: SAVIR Alpha Synch mobile (SASm)

Interventions

SAVIR Alpha Synch mobile (SASm) 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.

Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or over 18 years old
• Must have a permanent residence
• Diagnosis of optic neuropathy
• VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN \<33%
• Visual Field Index (VFI) 10-90%
• Clear optical apparatus
• Best-corrected VA of 20/400 or better in at least one eye
• 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).
• Scheduling
• Testing
• 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.

You may not qualify if:

• High intraocular pressure (over 27 mmHg)
• End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
• Advanced or unstable retinal diseases
• Pathological nystagmus
• Acute conjunctivitis
• Photosensitivity to flickering lights
• Non-ocular/ocular surgery within the previous 2 months to enrollment date
• Electric or electronic implants (e.g., cardiac pacemaker)
• Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed)
• Diagnosed epilepsy on medical treatment
• Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
• Metastatic disease
• Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks
• Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits
• Addiction (e.g., drug/alcohol dependence) that has not been in abstinent control for at least one year

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Jonathan Williams, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angeles Ramos, MD

CONTACT

929-455-5047; angeles.ramos@nyulangone.org

Maria de los Angeles Ramos, MD

CONTACT

929-455-5047; Angeles.Ramos@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): May 18, 2029
• Study Completion (Estimated): May 18, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Joseph.Panarelli@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)