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Electrical Stimulation

Electrical Stimulation for Glaucoma (rtACS Trial)

N/A
Recruiting
Led By Joel Schuman, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through month 6

Summary

This trial is testing if using a home device that sends small electrical pulses to the eyes can help treat open-angle glaucoma. This condition causes eye nerves to die off quickly, and the study aims to see if this new method is safe and effective.

Who is the study for?
Adults with open-angle glaucoma, stable eye pressure, and certain visual field measures can join. They must be able to follow the study plan and give informed consent. Excluded are those with significant retinopathy, unclear corneas, autoimmune diseases, recent participation in other drug trials for the eyes or systemically, pregnancy or lactation, mental conditions affecting study compliance or safety concerns like implanted non-MRI-compatible metals.
What is being tested?
The trial is testing a home device that provides electrical stimulation to the eye (rtACS) against a sham treatment to see if it's effective and safe for treating open-angle glaucoma over the long term. Participants will randomly receive either real rtACS or a fake version without actual stimulation.
What are the potential side effects?
Potential side effects may include discomfort at the site of stimulation, headache, dizziness or temporary vision changes due to electrical current application. The risk of more serious side effects is not specified but would be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active SAVIR Alpha Synch Mobile device (SASm)Experimental Treatment1 Intervention
Patients will receive active treatment with the device every other day over 8 weeks.
Group II: Sham SAVIR Alpha Synch Mobile device (SASm)Placebo Group1 Intervention
Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Open-Angle Glaucoma aim to reduce intraocular pressure (IOP) to prevent further optic nerve damage. Medications such as prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors work by either decreasing the production of aqueous humor or increasing its outflow. Surgical options, including trabeculectomy and laser therapy, also focus on enhancing fluid drainage from the eye. Electrical stimulation, as studied in the Home-Stimulation Device trial, offers a novel approach by potentially promoting nerve health and slowing degeneration, which is crucial for preserving vision in glaucoma patients. This method may complement traditional treatments by directly targeting the optic nerve's resilience against damage.

Find a Location

Who is running the clinical trial?

Wills EyeOTHER
80 Previous Clinical Trials
15,391 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,070 Total Patients Enrolled
NYU Langone HealthOTHER
1,407 Previous Clinical Trials
855,725 Total Patients Enrolled

Media Library

Repetitive, Transorbital Alternating Current Stimulation (rtACS) (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05626491 — N/A
Open-Angle Glaucoma Research Study Groups: Active SAVIR Alpha Synch Mobile device (SASm), Sham SAVIR Alpha Synch Mobile device (SASm)
Open-Angle Glaucoma Clinical Trial 2023: Repetitive, Transorbital Alternating Current Stimulation (rtACS) Highlights & Side Effects. Trial Name: NCT05626491 — N/A
Repetitive, Transorbital Alternating Current Stimulation (rtACS) (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626491 — N/A
~2 spots leftby Dec 2024