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

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. ^{1 2 3 4 5}

What 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. ^{4 5 6 7 8}

Is 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. ^{1 2 5 9 10}

Research Team

Joeseph F Panarelli, MD

Principal Investigator

NYU- Langone

Bernhard Sable, PhD

Principal Investigator

Otto-von-Guericke University Magdeburg

Joel Schuman, MD,FACS

Principal Investigator

Wills Eye

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Preclinical model of transcorneal alternating current stimulation in freely moving rats. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Transcutaneous periorbital electrical stimulation in the treatment of dry eye. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

The Efficacy of Transcorneal Electrical Stimulation for the Treatment of Primary Open-angle Glaucoma: A Pilot Study. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study. [2022]