21 Participants Needed

Electro-acupuncture + TES for Retinitis Pigmentosa

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Southeastern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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 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.12345

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.26789

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.267810

Who Is on the Research Team?

KR

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
See 2 more

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.
See 9 more

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?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcorneal Electrical StimulationExperimental Treatment1 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 acupunctureExperimental Treatment1 Intervention
Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period
Group III: Electro-acupunctureExperimental Treatment1 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-acupuncturePlacebo Group1 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 acupuncturePlacebo Group1 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 StimulationPlacebo Group1 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

Find a Clinic Near You

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.
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

Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: results from the TESOLAUK trial. [2022]
Outcomes of transcorneal electrical stimulation therapy in the early stages of retinitis pigmentosa. [2023]
Optical coherence tomography angiography findings in patients undergoing transcorneal electrical stimulation for treating retinitis pigmentosa. [2022]
Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study). [2021]
Longevity of visual improvements following transcorneal electrical stimulation and efficacy of retreatment in three individuals with retinitis pigmentosa. [2019]
Transcorneal Electrical Stimulation for Patients With Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Follow-up Study Over 1 Year. [2022]
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]
Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. [2022]
Effect of Transcorneal Electrical Stimulation on Patients with Retinitis Pigmentosa. [2021]
Metabolic Long-Term Monitoring of Transcorneal Electrical Stimulation in Retinitis Pigmentosa. [2022]
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