Electrical stimulation treatment for optic neuropathies

An Open-Label Study to Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies

This study is testing whether a home device that uses electrical stimulation can help improve eye nerve function in people with open-angle glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT05626426 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of long-term electrical stimulation using a home-stimulation device for patients with open-angle glaucoma. It is an open-label trial that includes participants who do not meet the criteria for a randomized clinical trial but are still considered safe for the intervention. The treatment involves repetitive transorbital alternating current stimulation (rtACS) to potentially improve nerve function in the eye. Participants will be monitored for their ability to comply with the study requirements and complete scheduled assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of open-angle glaucoma and stable eye pressure.

Not a fit: Patients with advanced glaucoma or those whose eye pressure is not clinically stable may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new non-invasive option for managing open-angle glaucoma and preserving vision.

How similar studies have performed: While this approach is novel, similar studies using electrical stimulation for optic nerve conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Participant must be at least 18.
2. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
3. Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false postivies do not exeed 20%.
4. In the opinion of the investigator the participant's eye pressure must be clinically stable.
5. If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
6. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

Exclusion Criteria:

1. Participant is unable to comply with study procedures or follow-up visits.
2. Participant has a history of ocular herpes zoster.
3. Participant has pathological nystagmus
4. Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
5. Participant has evidence of corneal opacification or lack of optical clarity.
6. Participant has uveitis or other ocular inflammatory disease.
7. Participant has any electric or electroinc implants such as a pacemaker.
8. Participant has acute conjunctivitis.
9. Participant has acute autoimmune disease.
10. Participant is pregnant or lactating.
11. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. Including but not limited to all forms of dementia.
12. Unresected brain tumors
13. Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable
14. Patients with any skin damage.
15. Children and comatose patients.
16. Patients with history of epileptic seizure within the last 10 years.
17. Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
18. Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation
19. Prior participation in a vision training/stimulation study in the last 12 months

Where this trial is running

Palo Alto, California

• Byers Eye Institute — Palo Alto, California, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey L Goldberg, MD PhD — Stanford University

Conditions Glaucoma; Glaucoma, Open-Angle; Optic Nerve Diseases