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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests 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 the device every other day for eight weeks. It suits individuals diagnosed with glaucoma who have stable eye pressure, but not those with certain eye conditions like retinopathy or with electric implants like pacemakers. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options for glaucoma.

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 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) might be safe for treating glaucoma. In studies, patients who received rtACS experienced improvements in their vision-related quality of life. These studies reported no serious side effects, suggesting the treatment is generally well-tolerated. Since the trial is in an early stage, known as the "Not Applicable" phase, the treatment is still being tested for safety. However, the absence of serious issues reported so far is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for glaucoma, which typically involve eye drops or surgery to reduce eye pressure, Repetitive Transorbital Alternating Current Stimulation (rtACS) offers a novel approach by using electrical stimulation. This method targets the optic nerve directly, potentially enhancing nerve function and vision without invasive procedures. Researchers are excited about rtACS because it represents a non-invasive technique that could complement or even enhance existing treatments, offering hope for improved visual outcomes in patients with glaucoma.

What evidence suggests that this device is effective for glaucoma?

Research has shown that repetitive transorbital alternating current stimulation (rtACS), which participants in this trial will receive, can enhance the quality of life for individuals with open-angle glaucoma by improving their vision. In one study, those who received rtACS experienced significant improvements in their vision-related quality of life compared to those who did not. This suggests that rtACS might activate certain cells in the eye crucial for vision, potentially improving their function. Although more research is needed, these early results are promising for people with open-angle glaucoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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)

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

In the opinion of the investigator, the participant's eye pressure must be clinically stable

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. 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 ...

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

Repetitive Transorbital Alternating Current Stimulation IOP was found to be significantly higher in individuals undergoing TES at 66% stimulation compared with the 0% stimulation sham group (P = .04); no significant ...

3. 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).

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03188042

A Study Using Transorbital Alternating Current Stimulation ... The expected outcomes for this project are that (1) rtACS activates viable but poorly or non-functional retinal ganglion cells to improve their structural and ...

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05626491

Electrical Stimulation for the Treatment of Glaucoma The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of ...

7. 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 ...

8. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/e/NCT05626491.html

Electrical Stimulation for the Treatment of Glaucoma The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of ...