Electrical Stimulation for Glaucoma

(rtACS Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Ocular herpes zoster, Retinopathy, Uveitis, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home device using electrical stimulation, specifically Repetitive, Transorbital Alternating Current Stimulation (rtACS), can safely and effectively treat open-angle glaucoma, a condition where eye nerves deteriorate faster than usual. Participants will use either an active device that provides real treatment or a sham device that does not, every other day for eight weeks. Eligible participants should have glaucoma with stable eye pressure and no history of certain eye or general health issues, such as severe diabetes or uncontrolled high blood pressure. The trial aims to discover a new way to manage glaucoma symptoms at home. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new home-based treatments for glaucoma.

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 prior data suggests that this home-stimulation device is safe for treating open-angle glaucoma?

Research has shown that repetitive transorbital alternating current stimulation (rtACS) is generally safe for people with optic nerve damage. In one study, participants who received rtACS experienced improvements in their vision without serious side effects. Specifically, they saw a significant increase in their visual field by about 24%, compared to only a 2.5% improvement in those who received a placebo treatment.

Studies have found that rtACS can help restore some vision by influencing brain activity related to sight. Importantly, these studies did not report any major negative effects, suggesting that the treatment is well-tolerated. So far, the evidence indicates that rtACS is a safe option for those with vision problems due to nerve damage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Repetitive, Transorbital Alternating Current Stimulation (rtACS) for glaucoma because it offers a novel approach by using electrical currents to potentially improve vision. Unlike traditional treatments like eye drops, laser therapy, or surgery, which focus on reducing eye pressure, rtACS targets the optic nerve directly. This method could enhance nerve function and slow down vision loss, providing a new hope for glaucoma patients.

What evidence suggests that this electrical stimulation device is effective for open-angle glaucoma?

Research has shown that repetitive transorbital alternating current stimulation (rtACS) might help treat open-angle glaucoma. In this trial, participants will receive either active rtACS treatment or a sham treatment with no active stimulation. Previous studies found that people who received rtACS showed more improvement from the start to four weeks after treatment compared to those who received a sham treatment. This improvement appeared in areas of life that rely on good vision, such as activities requiring close-up sight. The therapy uses electrical stimulation, which may support the nerve cells in the eyes. Although these findings are preliminary, they suggest that rtACS might help slow down or improve vision problems in glaucoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Bernhard Sable, PhD

Principal Investigator

Otto-von-Guericke University Magdeburg

Joeseph F Panarelli, MD

Principal Investigator

NYU- Langone

Joel Schuman, MD,FACS

Principal Investigator

Wills Eye

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I have cloudy or unclear vision due to my cornea.

I have been diagnosed with involuntary eye movements.

I have pink eye.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive, Transorbital Alternating Current Stimulation (rtACS)
• Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Trial Overview 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.

How Is the Trial Designed?

Group I: Active SAVIR Alpha Synch Mobile device (SASm) Experimental Treatment 1 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 Group 1 Intervention

Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Wills Eye

Collaborator

Trials

81

Recruited

15,400+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Otto-von-Guericke University Magdeburg

Collaborator

Trials

10

Recruited

2,700+

Published Research Related to This Trial

Transdermal electrical stimulation (TdES) was tested on five patients with central retinal artery occlusion (CRAO), showing slight improvements in visual acuity for two patients after treatment, indicating potential efficacy.

The study confirmed the safety of TdES, as no adverse events were reported, suggesting it could be a promising area for further research in treating CRAO, which currently lacks established therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory clinical trial to evaluate the efficacy and safety of transdermal electrical stimulation in patients with central retinal artery occlusion. Miura, G., Fujiwara, T., Iwase, T., et al.[2023]

Transcutaneous electrical stimulation significantly improved symptoms of dry eye in 27 patients, as measured by the Ocular Surface Disease Index (OSDI), with effects lasting up to 12 months after treatment.

The treatment was safe, with no reported complications, and led to a significant reduction in the need for tear substitutes, indicating its potential as an effective new option for managing dry eye symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous periorbital electrical stimulation in the treatment of dry eye. Pedrotti, E., Bosello, F., Fasolo, A., et al.[2018]

In a study involving 82 patients with optic nerve damage, repetitive transorbital alternating current stimulation (rtACS) significantly improved visual fields by an average of 24% compared to only 2.5% improvement in the sham group, with effects lasting at least 2 months.

The improvement in visual fields was linked to changes in brain activity, suggesting that rtACS may enhance brain plasticity, making it a promising and safe treatment option for restoring partial vision after optic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. Gall, C., Schmidt, S., Schittkowski, MP., et al.[2018]

Transcorneal electrical stimulation was evaluated in 5 eyes of 4 male subjects with primary open-angle glaucoma, showing a significant positive relationship between the number of treatments and improvements in visual field defects, suggesting potential efficacy.

Despite no significant changes in intraocular pressure, the treatment may help improve glaucomatous visual field defects, indicating a need for larger studies to confirm these promising preliminary results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Transcorneal Electrical Stimulation for the Treatment of Primary Open-angle Glaucoma: A Pilot Study. Ota, Y., Ozeki, N., Yuki, K., et al.[2018]

The study successfully developed a method for applying transcorneal alternating current stimulation (tACS) in awake rats, allowing for the simultaneous recording of brain activity without the interference of anesthesia, which is crucial for understanding brain function.

The setup demonstrated that tACS is safe and well-tolerated in freely-moving rats, enabling reliable recordings of visual responses, which paves the way for future research on visual recovery and treatment of visual diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical model of transcorneal alternating current stimulation in freely moving rats. Sergeeva, EG., Henrich-Noack, P., Gorkin, AG., et al.[2015]

Transcranial alternating current stimulation (tACS) can modify the responsiveness of Off-center and On-Off retinal ganglion cells in the rabbit retina, enhancing or suppressing their light-evoked responses without directly causing spiking activity.

The effects of tACS varied among different retinal ganglion cells, suggesting that it may influence the inner workings of the retina by acting on amacrine cells, which play a key role in processing visual information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tACS-Like Electrical Stimulation on Off- and On-Off Center Retinal Ganglion Cells: Part II. Strang, CE., Amthor, FR.[2022]

In a study involving 78 eyes from 46 patients with open-angle glaucoma, transpalpebral electrical stimulation significantly reduced intraocular pressure (IOP) from a baseline of approximately 19.25 mmHg to 14.41 mmHg after four months of treatment (P < 0.0001).

The treatment was effective for both patients already on maximum tolerated medical treatment and treatment-naïve patients, demonstrating a significant reduction in IOP for both groups, indicating its potential as a non-invasive therapeutic option for managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study. Gil-Carrasco, F., Ochoa-Contreras, D., Torres, MA., et al.[2022]

In a study involving 18 patients with optic nerve damage, repetitive transorbital alternating current stimulation (rtACS) over 10 days significantly increased alpha brain wave activity, suggesting that rtACS can enhance rhythmic brain activity.

Visual field improvements were observed after rtACS treatment, indicating potential therapeutic benefits for patients with visual deficits, although these improvements were not directly linked to changes in alpha-synchronization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive enhancement of alpha activity and visual function in patients with optic neuropathy: a two-week repeated session alternating current stimulation study. Schmidt, S., Mante, A., Rönnefarth, M., et al.[2022]

Transcranial alternating current stimulation (tACS) at 1 microampere significantly altered the responsiveness of On-center retinal ganglion cells in rabbits, affecting their light-evoked responses for up to several hours after stimulation.

The study found that tACS differentially influenced the initial and sustained responses to light, suggesting potential implications for enhancing visual processing and contrast sensitivity without directly causing significant firing changes in the cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tACS-Like Electrical Stimulation on On-Center Retinal Ganglion Cells: Part I. Amthor, FR., Strang, CE.[2022]

Noninvasive repetitive transorbital alternating current stimulation (rtACS) significantly improved detection ability in the visual field of patients with optic nerve damage, with a 41.1% increase compared to only 13.6% in the sham group, indicating its efficacy in vision restoration.

Patients receiving rtACS also reported greater improvements in vision-related quality of life, particularly in the 'general vision' subscale of the NEI-VFQ, suggesting that while visual field changes are important, other factors also influence overall quality of life related to vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy. Gall, C., Sgorzaly, S., Schmidt, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39584183/

Transorbital Alternating Current Stimulation in a Double- ... Results: The rtACS group showed a significantly greater improvement from baseline to 4 weeks posttreatment compared with sham in VR-QoL domains ...

2. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00150-7/fulltext

Transorbital Alternating Current Stimulation in a Double- ... Results. The rtACS group showed a significantly greater improvement from baseline to 4 weeks posttreatment compared with sham in VR-QoL domains ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666914524001507

Transorbital Alternating Current Stimulation in a Double- ... The rtACS group showed a significantly greater improvement from baseline to 4 weeks posttreatment compared with sham in VR-QoL domains including near activities ...

4. mdpi.com mdpi.com/2673-3269/5/3/26

Transorbital Alternating Current Stimulation in Glaucoma In this paper, we expose the most important data supporting the use of alternating current stimulation, including the theoretical bases of this approach, in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39956596/

the VIRON study protocol This clinical trial aims to prove the effectiveness of rtACS compared with sham stimulation in patients with primary open-angle glaucoma (POAG).

6. researchgate.net researchgate.net/publication/387572268_The_Efficacy_of_Repetitive_Transorbital_Alternating_Current_Stimulation_rtACS_in_Patients_With_Optic_Nerve_Damage_A_Systematic_Review_and_Meta-Analysis

The Efficacy of Repetitive Transorbital Alternating Current ... Conclusion: rtACS treatment is a safe and effective means to partially restore vision after optic nerve damage probably by modulating brain ...

7. glaucomatoday.com glaucomatoday.com/articles/2020-sept-oct/repetitive-transorbital-alternating-current-stimulation

Repetitive Transorbital Alternating Current Stimulation When patients underwent a second round of rtACS, their VFs remained significantly improved in both eyes compared with baseline.11 This finding was confirmed by ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0156134

Alternating Current Stimulation for Vision Restoration after ... The rtACS-treated group had a mean improvement in visual field of 24.0% which was significantly greater than after sham-stimulation (2.5%). This improvement ...