A Study Using Transorbital Alternating Current Stimulation for People With 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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new electric current treatment for people with glaucoma to improve their vision and quality of life by stimulating underperforming parts of their eyes and brain.

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 data supports the effectiveness of the treatment rtACS Stimulation?

Research on similar treatments, like spinal cord stimulation, shows that electrical stimulation can help improve movement and quality of life in people with spinal cord injuries. This suggests that rtACS Stimulation might also be effective in similar ways. ^{1 2 3 4 5}

Research Team

Joel Schuman, MD, FACS

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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)

Treatment Details

Interventions

• rtACS Stimulation
• Sham Intervention

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

2. United States 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. [2023]

3. England 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. [2023]

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

Mode of induction of ventricular tachycardia and prognosis in patients with coronary disease: the Multicenter UnSustained Tachycardia Trial (MUSTT). [2009]

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

Fantastic Four: Age, Spinal Cord Stimulator Waveform, Pain Localization and History of Spine Surgery Influence the Odds of Successful Spinal Cord Stimulator Trial. [2020]