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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for retinitis pigmentosa (RP), a progressive eye disease affecting vision. Researchers are testing electro-acupuncture and transcorneal electrical stimulation (TES) to determine if these methods can improve vision in people with RP. Participants may receive either real or sham (fake) treatments to compare results. The trial suits those diagnosed with RP who still have some vision and are willing to attend multiple sessions over 4-6 months. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both electro-acupuncture and transcorneal electrical stimulation (TES) are generally safe for people. Research indicates that electro-acupuncture has not resulted in serious side effects. Some individuals have experienced mild discomfort, but it is usually manageable.

Regarding transcorneal electrical stimulation, multiple studies have confirmed its safety. TES has been used in individuals with retinitis pigmentosa (RP) without causing serious side effects. It is considered a safe method to potentially slow the progression of RP. Overall, existing research suggests that both treatments are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for retinitis pigmentosa, which primarily focus on slowing vision loss through vitamin supplements or low vision aids, the new approaches of electro-acupuncture and transcorneal electrical stimulation (TES) offer unique mechanisms of action. Electro-acupuncture targets specific acupoints around the eyes to potentially improve retinal function and overall eye health, while TES delivers electrical currents to the retina, possibly enhancing its activity and health. These innovative techniques are non-invasive and have the potential to not just slow down vision loss but also improve retinal activity, which is what has researchers excited.

What evidence suggests that this trial's treatments could be effective for retinitis pigmentosa?

This trial will evaluate the effects of electro-acupuncture and transcorneal electrical stimulation (TES) as separate treatments for retinitis pigmentosa (RP). Studies have shown that electro-acupuncture can improve vision in people with RP. Specifically, one study found it increased retinal blood flow by up to 34% compared to placebo treatments. Another report showed that 83.3% of participants experienced better vision and improved results on a test measuring the brain's response to visual signals.

For TES, research suggests it can enhance vision in people with RP and other eye conditions. Patients reported a high satisfaction rate of 95.24% with TES, and studies observed significant improvements in retinal blood flow after treatment. Both treatments show promise in improving vision for those with RP. ^{1 2 4 5 6}

Who Is on the Research Team?

Kenneth R Seger, OD, MSc

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5920686/

Randomized Controlled Trial of Electro-stimulation Therapies ... TES and electro-acupuncture subjects had significant 55% and 34% greater increases, respectively, in RBF in the macular vessels when compared to sham controls ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925001104

Is acupuncture a viable therapeutic strategy for ... (2009), who found a total effective rate of 83.3 % and a statistically significant improvement in vision and VEP outcomes. Even more, Tan Q. et al. (2006) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8593745/

Acupuncture for retinitis pigmentosa: study protocol for a ... Acupuncture can improve the microcirculation of local ocular tissues and shorten the pathological reaction, which plays a good role in RP. Bittner et al ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02086890

Electro-acupuncture and Transcorneal Electrical ... The goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in RP patients ...

5. withpower.com withpower.com/trial/phase-retinitis-7-2014-70ba5

Electro-acupuncture + TES for Retinitis Pigmentosa 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 ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/11/11/e049245

Acupuncture for retinitis pigmentosa: study protocol for a ... This trial aims to determine the efficacy and safety of acupuncture versus sham acupuncture (SA) for RP.