Electrical Stimulation for the Treatment of Optic Neuropathies

NCT ID: NCT05626426

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2027-12-31

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.

Detailed Description

This is a concurrent open-label study for patients who are deemed safe to participate in the electrical stimulation trial but do not fit the exact criteria for the randomized clinical trial.

Conditions

Glaucoma; Glaucoma, Open-Angle; Optic Nerve Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active SASm

Patients will receive active treatment with the device every other day over 8 weeks.

Group Type: EXPERIMENTAL

Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Intervention Type: DEVICE

Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina

Interventions

Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina

Intervention Type: DEVICE

Other Intervention Names

Electrical Stimulation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L Goldberg

Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey L Goldberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Byers Eye Institute

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Study Team

Role: primary

glaucomatrials@stanford.edu

650-497-5942

Other Identifiers

68207

Identifier Type: -

Identifier Source: org_study_id