Electro-acupuncture + TES for Retinitis Pigmentosa

Recruiting in Palo Alto (17 mi)

Overseen ByKenneth R Seger, OD, MSc

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nova Southeastern University

No Placebo Group

Trial Summary

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.

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

I have been diagnosed with retinitis pigmentosa.

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.

I have dementia or memory loss.

I cannot read or speak English.

I have a history of excessive bleeding.

Participant Groups

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.

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