Electro-acupuncture + TES for Retinitis Pigmentosa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Severe vision loss, Dementia, Pregnancy, others

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

Compensation: Varies

Number of Visits: 12

Duration: 2 weeks

21 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that systemic medications that may affect the treatment response could be a concern. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Electro-acupuncture + TES for Retinitis Pigmentosa?

Research shows that transcorneal electrical stimulation (TES) can help improve vision in some people with retinitis pigmentosa, a condition that causes gradual vision loss. In one study, four out of seven participants experienced better vision after TES treatment. ^{1 2 3 4 5}

Is Electro-acupuncture + TES safe for humans?

Transcorneal electrical stimulation (TES) has been studied for retinitis pigmentosa and found to be generally safe, with no serious side effects reported. Some mild dry eye symptoms were noted, which were manageable with artificial tears. ^{1 6 7 8 9}

How is the Electro-acupuncture + TES treatment for retinitis pigmentosa different from other treatments?

This treatment is unique because it combines electro-acupuncture, which uses small electrical currents at acupuncture points, with transcorneal electrical stimulation (TES), a novel approach that applies electrical currents to the eye to potentially improve retinal function. Unlike other treatments, TES specifically targets the eye's electrical activity, which may help slow the progression of retinitis pigmentosa. ^{1 2 3 4 10}

What is the purpose of this trial?

This trial is testing a treatment called transcorneal electrical stimulation for people with retinitis pigmentosa, a condition that leads to gradual vision loss. The treatment uses small electrical currents applied to the eye to improve blood flow and stimulate retinal cells, which may help slow down vision loss. Transcorneal electrical stimulation has shown several improvements in visual function in previous studies and is currently offered by several companies.

Research Team

Kenneth R Seger, OD, MSc

Principal Investigator

Faculty

Eligibility Criteria

This trial is for adults over 18 with retinitis pigmentosa, having some vision left (better than 20/400 in one eye) and a significant visual field loss. Participants must be able to consent and commit to study visits for about 4-6 months. Exclusions include unstable mental health, prior treatments like acupuncture or TES for RP, severe cognitive impairments, pacemakers, pregnancy, extreme vision loss that prevents test participation, other ocular diseases or health issues affecting treatment response.

Inclusion Criteria

Best-corrected visual acuity better than 20/400 in at least one eye

More than 20% loss of Goldmann Visual Field area (III4e test target) in at least one eye

Provide informed consent

Exclusion Criteria

I am currently receiving care for my mental health.

My vision loss is not caused by RP, cystoid macular edema, or cataracts.

I can understand and respond to study procedures and visual stimuli.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either electro-acupuncture or transcorneal electrical stimulation, with sessions occurring over a 2-week period

2 weeks

10 sessions (in-person) for acupuncture, 6 sessions (in-person) for electrical stimulation

Follow-up

Participants are monitored for changes in vision and ocular health at multiple intervals post-treatment

12 weeks

Visits at 2 weeks, 6 weeks, and 12 weeks post-treatment

Treatment Details

Interventions

• Electro-acupuncture
• Transcorneal Electrical Stimulation

Trial Overview The trial tests the effectiveness of electro-acupuncture and transcorneal electrical stimulation (TES) on improving vision in patients with retinitis pigmentosa. It includes control groups receiving sham procedures to compare results against actual treatments. The goal is to determine if these therapies can enhance visual function.

Participant Groups

Group I: Transcorneal Electrical Stimulation Experimental Treatment 1 Intervention

Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions

Group II: Laser acupuncture Experimental Treatment 1 Intervention

Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period

Group III: Electro-acupuncture Experimental Treatment 1 Intervention

Electro-acupuncture applied to acupoints around the eye and traditional needle acupuncture applied to acupoints throughout the body at 10 half-hour sessions over 2 weeks

Group IV: Sham Electro-acupuncture Placebo Group 1 Intervention

No electro-acupuncture applied to non-acupoints around the eye and traditional needle acupuncture applied to non-acupoints throughout the body; i.e., to locations not on the acupuncture meridians; at 10 half-hour sessions over 2 weeks

Group V: Sham Laser acupuncture Placebo Group 1 Intervention

An inactive sham laser (red light only) applied to non-acupoints throughout the body; i.e., to locations not on the acupuncture meridians; at 10 sessions each lasting 15 minutes over a 2 week period

Group VI: Sham Transcorneal Electrical Stimulation Placebo Group 1 Intervention

Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

Transdermal electrical stimulation (TdES) has previously shown safety and efficacy in improving visual functions in patients with retinitis pigmentosa, with no adverse events reported during follow-up.

A new clinical trial is set to compare the effectiveness of TdES against a sham treatment in 50 patients over 24 weeks, focusing on changes in visual acuity and other visual function metrics, ensuring rigorous ethical standards and oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy and safety of transdermal electrical stimulation on the visual functions of patients with retinitis pigmentosa: a clinical trial protocol for a prospective, multicentre, randomised, double-masked and sham-controlled design (ePICO trial). Miura, G., Ozawa, Y., Shiko, Y., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: results from the TESOLAUK trial. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

Outcomes of transcorneal electrical stimulation therapy in the early stages of retinitis pigmentosa. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Optical coherence tomography angiography findings in patients undergoing transcorneal electrical stimulation for treating retinitis pigmentosa. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study). [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Longevity of visual improvements following transcorneal electrical stimulation and efficacy of retreatment in three individuals with retinitis pigmentosa. [2019]

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

Transcorneal Electrical Stimulation for Patients With Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Follow-up Study Over 1 Year. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy and safety of transdermal electrical stimulation on the visual functions of patients with retinitis pigmentosa: a clinical trial protocol for a prospective, multicentre, randomised, double-masked and sham-controlled design (ePICO trial). [2022]

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

Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. [2022]

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

Effect of Transcorneal Electrical Stimulation on Patients with Retinitis Pigmentosa. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Metabolic Long-Term Monitoring of Transcorneal Electrical Stimulation in Retinitis Pigmentosa. [2022]