Electrical Stimulation for the Treatment of Optic Neuropathies

NCT05626426 | Recruiting FDA Device

• 1 other identifier: 68207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Glaucoma, Open-Angle; Optic Nerve Diseases

Outcome Measures

Primary Outcomes (2)

• Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).

  Baseline through 6 months

• Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).

  Baseline through 6 months

Secondary Outcomes (8)

• Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared).

  Baseline through 6 months

• Change from baseline in nerve fiber layer thickness as measured by optical coherence tomography (OCT, visible light and/or infrared).

  Baseline through 6 months

• Change from baseline in visual acuity as assessed by the Snellen visual acuity test.

  Baseline through Month 6

• Change from baseline in visual evoked potential.

  Baseline through Month 6

• Change from baseline in retinal metabolic analysis(RMA)/OcuMet imaging.

  Baseline through Month 6

Study Arms (1)

Active SASm

EXPERIMENTAL

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

Device: Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Interventions

Repetitive, Transorbital Alternating Current Stimulation (rtACS) DEVICE

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

Also known as: Electrical Stimulation

Active SASm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be at least 18.
• Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
• 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%.
• In the opinion of the investigator the participant's eye pressure must be clinically stable.
• 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.
• 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.

You may not qualify if:

• Participant is unable to comply with study procedures or follow-up visits.
• Participant has a history of ocular herpes zoster.
• Participant has pathological nystagmus
• Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
• Participant has evidence of corneal opacification or lack of optical clarity.
• Participant has uveitis or other ocular inflammatory disease.
• Participant has any electric or electroinc implants such as a pacemaker.
• Participant has acute conjunctivitis.
• Participant has acute autoimmune disease.
• Participant is pregnant or lactating.
• 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.
• Unresected brain tumors
• 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
• Patients with any skin damage.
• Children and comatose patients.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Optic Nerve Diseases

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Jeffrey L Goldberg, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 27, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)