Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
NYU Langone Health · NCT06662448
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 70
- US sites recruiting
- 1
- Study start
- November 18, 2024
- Record last updated
- February 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: SAVIR Alpha Synch mobile (SASm)
Conditions: Optic Neuropathy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
NYU Langone Health
New York, NY 10022
Study contacts (from the official record)
- Angeles Ramos, MD · 929-455-5047 · angeles.ramos@nyulangone.org
- Maria de los Angeles Ramos, MD · 929-455-5047 · Angeles.Ramos@nyulangone.org
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