Electric Current Treatment for Glaucoma

Overseen By Joel Schuman, MD, FACS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Diabetes, Stroke, Epilepsy, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy for glaucoma-related vision loss using repetitive transorbital alternating current stimulation (rtACS). The goal is to determine if this treatment can improve eye function and quality of life for individuals with moderate to severe glaucoma. Participants will receive either the rtACS treatment or a sham (inactive) version for comparison. Those with glaucoma, who have experienced visual field defects for at least six months and maintain decent vision in at least one eye, may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for glaucoma.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this method is safe for treating visual impairment in people with glaucoma?

Research shows that the safety of repetitive transorbital alternating current stimulation (rtACS) is not yet fully understood. Some studies have examined its effects, but clear information on its safety remains limited. Detailed reports on how well people tolerate it or what side effects might occur are scarce. Since this treatment is still in early testing, further research is needed to confirm its safety in humans.

While researchers study rtACS for its potential benefits, participants should know that its safety is still under investigation. Participants should discuss any concerns with the study team to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for glaucoma that often involve eye drops or surgery to reduce eye pressure, transorbital alternating current stimulation (rtACS) offers a non-invasive approach by using electrical currents to potentially improve vision. Researchers are excited about rtACS because it targets the visual pathways in the brain directly, which could enhance visual processing and preserve sight without the need for medication or surgery. This method could open new avenues for managing glaucoma, especially for patients who struggle with existing therapies.

What evidence suggests that rtACS is effective for treating visual impairment in glaucoma?

Studies have shown that repetitive transorbital alternating current stimulation (rtACS), which participants in this trial may receive, might help improve vision in people with glaucoma. For example, one study found that rtACS improved peripheral vision in patients with optic nerve damage. Another study reported that people who received rtACS experienced greater improvement in their vision-related quality of life compared to those in the control group, who received a sham intervention. Additionally, rtACS has been linked to increased activity in certain eye cells important for vision. Overall, these findings suggest that rtACS could effectively improve vision and quality of life for people with glaucoma. ^{1 6 7 8 9}

Who Is on the Research Team?

Joel Schuman, MD, FACS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

Live in a community, residential setting (i.e., non-institutionalized, not homeless)

Diagnosis of glaucoma (not type-specific, excluding traumatic glaucoma): Moderate defect or worse in both eyes but not total blindness

Visual field defects present for at least 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments to measure visual function and quality of life

1 week

1 visit (in-person)

Intervention

Participants receive transorbital alternating current stimulation (rtACS) or sham stimulation

4 weeks

4 visits (in-person)

Post-intervention

Participants undergo assessments to evaluate changes in visual function and quality of life

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• rtACS Stimulation
• Sham Intervention

How Is the Trial Designed?

Group I: rtACS Stimulation Group Experimental Treatment 1 Intervention

Group II: Sham Intervention Group Placebo Group 1 Intervention

Sham stimulation looks like rtACS, but is not active rtACS.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a 36-month study involving participants with chronic pain, ECAP-controlled closed-loop spinal cord stimulation (CL-SCS) resulted in a significantly higher percentage of patients achieving at least a 50% reduction in pain compared to fixed-output open-loop stimulation (OL-SCS) (77.6% vs 49.3%).

CL-SCS not only provided better pain relief but also led to greater improvements in overall quality of life and neural activation without increasing adverse events, indicating its efficacy and safety as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Mekhail, NA., Levy, RM., Deer, TR., et al.[2023]

In a study of 25 patients with chronic motor complete spinal cord injury, spinal cord epidural stimulation (scES) was found to be safe, with only 8% experiencing infections and 12% requiring additional procedures, while all participants achieved voluntary movement after the intervention.

The majority of patients (85%) reported that scES met or exceeded their expectations, and 100% expressed willingness to undergo the procedure again, indicating significant improvements in motor function and quality of life after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. Boakye, M., Ball, T., Dietz, N., et al.[2023]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39886696/

The Efficacy of Repetitive Transorbital Alternating Current ... The use of rtACS shows a promising effect in improving the detection accuracy of the VF for patients with optic nerve damage, with a significant benefit over ...

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. 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 ...

4. 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 ...

5. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(22)01262-4/abstract

Correlation of Clinical and Neurophysiological Results We recently observed a significant increase of visual evoked potentials (VEP) amplitude after rtACS in a small group of patients with severe low ...

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

Transorbital Alternating Current Stimulation in a Double- ... Purpose. To determine the efficacy and safety of repetitive transorbital alternating current stimulation (rtACS) treatment by assessing vision-related quality ...

7. cureus.com cureus.com/articles/313971-the-efficacy-of-repetitive-transorbital-alternating-current-stimulation-rtacs-in-patients-with-optic-nerve-damage-a-systematic-review-and-meta-analysis.pdf

The Efficacy of Repetitive Transorbital Alternating Current ... Furthermore, the lack of substantial safety data limits the ability to fully endorse rtACS without reservations. One strength of this review ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01270126

Trial of Alternating Current Stimulation in Optic Neuropathy The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11781289/

The Efficacy of Repetitive Transorbital Alternating Current ... Furthermore, the lack of substantial safety data limits the ability to fully endorse rtACS without reservations. One strength of this review ...