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NCT Number: NCT06662448

Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

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).

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Key information

Conditions

Optic Neuropathy Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10022, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Uncontrolled systemic hypertension (historical BP > 160/100 mmHg)
  • 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
  • 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
  • IOP that the principal investigator determines that is not clinically stable
  • Complete blindness of both eyes
  • Non-resected brain tumors
  • Unstable diabetic retinopathy in the study eye
  • Optic neuropathies secondary to brain tumors
  • Subjects without the capacity to consent

Treatment and study plan

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.

Primary outcomes

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

    Time frame: baseline, 1 week post-intervention

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

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

    Time frame: baseline, 3 months post-intervention

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

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

    Time frame: baseline, 6 months post-intervention

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

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

    Time frame: baseline, 1 week post-intervention

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

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

    Time frame: baseline, 3 months post-intervention

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

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

    Time frame: baseline, 6 months post-intervention

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

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

    Time frame: baseline, 1 week post-intervention

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

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

    Time frame: baseline, 3 months post-intervention

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

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

    Time frame: baseline, 6 months post-intervention

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

  10. Change in Humphrey Visual Field Analyzer (HFA) score

    Time frame: baseline, 1 week 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.

  11. Change in Humphrey Visual Field Analyzer (HFA) score

    Time frame: baseline, 3 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.

  12. Change in Humphrey Visual Field Analyzer (HFA) score

    Time frame: 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.

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

    Time frame: baseline, 1 week 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.

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

    Time frame: baseline, 3 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.

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

    Time frame: 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.

  16. Change in Pelli-Robson score

    Time frame: baseline, 1 week 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.

  17. Change in Pelli-Robson score

    Time frame: baseline, 3 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.

  18. Change in Pelli-Robson score

    Time frame: 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.

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

    Time frame: baseline, 1 week post-intervention

    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.

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

    Time frame: baseline, 3 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.

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

    Time frame: 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 outcomes

  1. Number of scheduled clinical appointments reviewed

    Time frame: Month 6

  2. Number of patients considered potentially eligible as determined during review of the clinical appointment schedule

    Time frame: Month 6

  3. Number of patients who are potentially eligible but express no interest in participating in the study

    Time frame: Month 6

  4. Number of patients who are determined ineligible following screening procedures

    Time frame: Month 6

  5. Number of participants' who adhered to the study protocol regimen

    Time frame: Month 6

Study contacts

Contact information is provided by the study sponsor or research team.

Angeles Ramos, MD

CONTACT

[email protected]

929-455-5047

Maria de los Angeles Ramos, MD

CONTACT

[email protected]

929-455-5047

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 29, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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