What is the mechanism of action of this treatment?

The most common treatments for Retinitis Pigmentosa (RP) include Transcorneal Electrical Stimulation (TES) and vitamin A supplementation. TES enhances retinal cell function and promotes cell survival by stimulating neurotrophic factors and protective enzymes, which help maintain retinal health. Vitamin A aims to slow disease progression by supporting photoreceptor function, though it carries potential risks. These treatments are significant for RP patients as they focus on preserving retinal cells and delaying degeneration, thereby helping to maintain vision for a longer time.

What side effects are associated with this type of intervention?

Common treatments for Retinitis Pigmentosa include vitamin A supplementation, which can cause liver toxicity and hypervitaminosis A, and light exposure management, which generally has minimal side effects but may cause discomfort or eye strain. For treatments similar to Transcorneal Electrical Stimulation (TES), such as other forms of electrical stimulation, side effects can include mild discomfort, tingling, and lightheadedness. TES itself is being studied for its potential to enhance retinal cell function and promote cell survival, but specific side effects are not well-documented yet.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Retinitis Pigmentosa that are similar to Transcorneal Electrical Stimulation (TES). TES is being studied for its potential to enhance retinal cell function and promote cell survival in RP patients. Current treatments for RP are limited and primarily focus on managing symptoms and slowing disease progression. These include the use of vitamin A, omega-3 fatty acids, and, in some cases, retinal implants. Clinical trials and research are ongoing to find more effective therapies.

What other types of research exist?

Promising novel alternatives to Transcorneal Electrical Stimulation for Retinitis Pigmentosa patients include optogenetics, chemical interfaces, and ultrasonic retinal stimulation. These emerging technologies offer potential for non-invasive vision restoration and are currently under active research and development.

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Behavioural Intervention

Electro-acupuncture + TES for Retinitis Pigmentosa

N/A

Waitlist Available

Led By Kenneth R Seger, OD, MSc

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of retinitis pigmentosa (RP)

Be older than 18 years old

Must not have

Receiving current psychiatric care (i.e. unstable emotional and mental health status)

Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the acupuncture site, headache or dizziness post-treatment; TES might cause temporary visual disturbances or eye irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with retinitis pigmentosa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving care for my mental health.

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

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

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I have dementia or memory loss.

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I cannot read or speak English.

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I have a history of excessive bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Significant changes from baseline in Goldmann visual field area in both eyes

Secondary study objectives

Changes in Macular edema Optical Coherence Tomography (OCT)

Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation

Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation

+1 more

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Laser Acupuncture

2012

N/A

~1030

Electro-acupuncture

2012

Completed Phase 1

~150

Transcorneal Electrical Stimulation

2013

N/A

~180

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Retinitis Pigmentosa (RP) include Transcorneal Electrical Stimulation (TES) and vitamin A supplementation. TES enhances retinal cell function and promotes cell survival by stimulating neurotrophic factors and protective enzymes, which help maintain retinal health. Vitamin A aims to slow disease progression by supporting photoreceptor function, though it carries potential risks. These treatments are significant for RP patients as they focus on preserving retinal cells and delaying degeneration, thereby helping to maintain vision for a longer time.

Topographic Quantification of the Transcorneal Electrical Stimulation (TES)-Induced Protective Effects on N-Methyl-N-Nitrosourea-Treated Retinas.[Survival factors in the treatment of hereditary retinal degeneration].