Electrical Stimulation for Glaucoma

(rtACS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 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 eye can help treat open-angle glaucoma. It focuses on patients who are safe for this treatment but don't fit other trial criteria. The electrical pulses might help protect the eye nerves.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Repetitive Transorbital Alternating Current Stimulation (rtACS) for glaucoma?

Research suggests that rtACS can improve visual deficits and enhance brain activity in patients with optic nerve damage, which may be relevant for treating glaucoma. It has been shown to improve visual field size and quality of life in these patients, indicating potential benefits for vision-related conditions. ^{1 2 3 4 5}

Is electrical stimulation safe for humans?

Research on electrical stimulation, including rtACS, suggests it is generally safe for humans, as studies have evaluated its safety in conditions like optic neuropathy and central retinal artery occlusion. ^{1 3 6 7 8}

How is the treatment Repetitive Transorbital Alternating Current Stimulation (rtACS) different from other treatments for glaucoma?

Repetitive Transorbital Alternating Current Stimulation (rtACS) is unique because it uses electrical currents applied through the skin around the eyes to potentially improve visual function by enhancing brain activity, unlike traditional treatments that often focus on reducing eye pressure or using medications. ^{1 2 5 9 10}

Research Team

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Eligibility Criteria

Adults with open-angle glaucoma, stable eye pressure, and specific visual field loss can join this trial. They must be able to follow the study plan and give informed consent. Excluded are those with certain eye conditions, seizures in the last 10 years, electronic implants like pacemakers, skin damage or acute diseases, pregnant or lactating women, recent vision study participants, uncontrolled hypertension or diabetes.

Inclusion Criteria

Participant must have the ability to comply with the requirements of the study and complete the schedule of events (SOE)

I am at least 18 years old.

If both my eyes qualify, I can choose which one to enter into the study or let it be chosen randomly.

Exclusion Criteria

Participant is unable to comply with study procedures or follow-up visits

I have pink eye.

I am either a child or currently in a coma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active treatment with the device every other day over 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Trial Overview The trial is testing a home device that provides long-term electrical stimulation (rtACS) to see if it's effective and safe for treating optic nerve damage caused by open-angle glaucoma.

Participant Groups

Group I: Active SASm Experimental Treatment 1 Intervention

Patients will receive active treatment 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+

Otto-von-Guericke University Magdeburg

Collaborator

Trials

10

Recruited

2,700+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. 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]

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

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

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

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

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

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

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

8. 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]

9. 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]

10. Japan pubmed.ncbi.nlm.nih.gov

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