Could a headband device at home help save your sight?
NCT ID NCT06662448
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a gentle electrical stimulation device, used at home every other day for 8 weeks, can slow vision loss and improve daily function in people with optic neuropathy. Researchers will measure changes in eye structure, visual field, and quality of life in 70 adults. The goal is to see if this non-invasive approach is a practical way to manage progressive vision loss.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10022, United States
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