NCT05626426 Electrical Stimulation for the Treatment of Optic Neuropathies
| NCT ID | NCT05626426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-02-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.
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
Contact & Investigator
Jeffrey L Goldberg, MD PhD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05626426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05626426 currently recruiting?
Yes, NCT05626426 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT05626426 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT05626426 clinical trial?
NCT05626426 is sponsored by Stanford University. The principal investigator is Jeffrey L Goldberg, MD PhD at Stanford University. The trial plans to enroll 40 participants.