Electrical Stimulation for Glaucoma
(rtACS Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byJeffrey L Goldberg, MD PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Ocular herpes zoster, Retinopathy, Uveitis, Pacemaker, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have been in another clinical trial involving drugs in the last 3 months.
What data supports the idea that Electrical Stimulation for Glaucoma is an effective treatment?
The available research shows that Electrical Stimulation for Glaucoma, specifically repetitive transorbital alternating current stimulation (rtACS), can improve visual deficits in patients with optic nerve damage. Studies indicate that rtACS can enhance visual field size and improve vision-related quality of life. Although the exact mechanisms are not fully understood, these improvements suggest that rtACS could be a promising treatment for vision issues related to optic neuropathy.
12345What safety data exists for electrical stimulation treatment for glaucoma?
The study titled 'Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy' provides relevant safety data. It suggests that noninvasive repetitive transorbital alternating current stimulation (rtACS) is used to improve visual field size in patients with optic nerve damage, indicating its application in a clinical setting. However, specific safety outcomes are not detailed in the abstract. Other studies listed focus on different applications of electrical stimulation, such as for dry eye or central retinal artery occlusion, and do not directly address safety data for rtACS in glaucoma.
45678Is the treatment Repetitive, Transorbital Alternating Current Stimulation (rtACS) a promising treatment for glaucoma?
Yes, rtACS is a promising treatment for glaucoma. It has been shown to improve visual deficits in patients with optic nerve damage and may enhance brain activity related to vision recovery. This suggests it could be a novel therapeutic option for improving vision in glaucoma patients.
125910Eligibility Criteria
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.Inclusion Criteria
Visual Field Index between 10 and 90%
In the opinion of the investigator, the participant's eye pressure must be clinically stable
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
+5 more
Exclusion Criteria
I have cloudy or unclear vision due to my cornea.
I have been diagnosed with involuntary eye movements.
I have pink eye.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either active or sham treatment with the SAVIR Alpha Synch Mobile device every other day over 8 weeks
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wills Eye HospitalPhiladelphia, PA
Byers Eye InstitutePalo Alto, CA
NYU- LangoneNew York, NY
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
Wills EyeCollaborator
NYU Langone HealthCollaborator
Otto-von-Guericke University MagdeburgCollaborator
References
Effects of tACS-Like Electrical Stimulation on On-Center Retinal Ganglion Cells: Part I. [2022]Electrical stimulation of the human central nervous system via surface electrodes has been used for both learning enhancement and the amelioration of neurodegenerative or psychiatric disorders. However, data are sparse on how such electrical stimulation affects neural circuits at the cellular level. This study assessed the effects of tACS-like currents at 10 Hz on On-center retinal ganglion cell responsiveness, using the rabbit retina eyecup preparation as a model for central nervous system effects.
Progressive enhancement of alpha activity and visual function in patients with optic neuropathy: a two-week repeated session alternating current stimulation study. [2022]Repetitive transorbital alternating current stimulation (rtACS) can improve visual deficits in patients with optic nerve damage. Recent retrospective results suggest that rtACS enhances oscillatory brain activity. The exact mechanisms of rtACS are unclear and little is known about possibly frequency-specific neural-plastic mechanisms. An association between bandwidth-confined neural-entrainment and vision recovery maximization could offer a novel therapeutic option for patients with optic neuropathy.
Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. [2018]Vision loss after optic neuropathy is considered irreversible. Here, repetitive transorbital alternating current stimulation (rtACS) was applied in partially blind patients with the goal of activating their residual vision.
Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy. [2022]Noninvasive repetitive transorbital alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage, but it is not known if this is of subjective relevance. We now assessed patient reported outcomes to determine the association between visual field changes and vision-related quality of life (QoL).
Effects of tACS-Like Electrical Stimulation on Off- and On-Off Center Retinal Ganglion Cells: Part II. [2022]Transcranial alternating current stimulation (tACS) is used as a brain stimulation mechanism to enhance learning, ameliorate some psychiatric disorders, and modify behavior. This study assessed the effects of near threshold tACS-like currents on Off-center and On-Off retinal ganglion cell responsiveness in the rabbit retina eyecup preparation as a model for central nervous system effects.
Exploratory clinical trial to evaluate the efficacy and safety of transdermal electrical stimulation in patients with central retinal artery occlusion. [2023]To evaluate the efficacy and safety of transdermal electrical stimulation (TdES) using skin electrodes in patients with central retinal artery occlusion (CRAO).
Preclinical model of transcorneal alternating current stimulation in freely moving rats. [2015]Transcorneal alternating current stimulation (tACS) has become a promising tool to modulate brain functions and treat visual diseases. To understand the mechanisms of action a suitable animal model is required. However, because existing animal models employ narcosis, which interferes with brain oscillations and stimulation effects, we developed an experimental setup where current stimulation via the eye and flicker light stimulation can be applied while simultaneously recording local field potentials in awake rats.
Transcutaneous periorbital electrical stimulation in the treatment of dry eye. [2018]To evaluate efficacy and safety of transcutaneous application of electrical current on symptoms and clinical signs of dry eye (DE).
The Efficacy of Transcorneal Electrical Stimulation for the Treatment of Primary Open-angle Glaucoma: A Pilot Study. [2018]The aim of this study was to evaluate the effects of transcorneal electrical stimulation in subjects with primary open-angle glaucoma. Five eyes of four male subjects with primary open-angle glaucoma (average age: 52.25 ± 14.68 years) were enrolled. The subjects underwent transcorneal electrical stimulation every 3 months according to the following procedure. A Dawson-Trick-Litzkow electrode was placed on the cornea, and biphasic electric current pulses (10 ms, 20 Hz) were delivered using a stimulator (BPG-1,BAK Electronics) and a stimulus isolation unit (BSI-2). A current that evoked a phosphene that the subject perceived in the whole visual area was delivered continuously for 30 min. Humphrey visual field testing was performed after every third transcorneal electrical stimulation treatment. Changes in mean deviation (MD) values were evaluated with a linear regression model. Transcorneal electrical stimulation was performed 18.2 ± 9.4 times over a period of 49.8 ± 23.0 months. The average pretranscorneal electrical stimulation intraocular pressure, best corrected visual acuity, and MD values were 11.8 ± 1.79 mmHg, 0.14 ± 0.19 (logMAR) and -17.28 ± 6.24 dB, respectively. No significant differences were observed in intraocular pressure before and after transcorneal electrical stimulation. However, there was a significant positive linear relationship between changes in MD values and the number of transcorneal electrical stimulation treatments (R2 = 0.176, P = 0.005, Spearman correlation R =0.294, P = 0.008). Transcorneal electrical stimulation treatment may improve glaucomatous visual field defects in subjects with primary open-angle glaucoma. Large-scale studies are necessary to confirm these preliminary findings.
Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study. [2022]To determine the effect on intraocular pressure of transpalpebral specific exogenous voltages in a cohort of open-angle glaucoma patients.