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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing a new therapy for a degenerative eye disease using electrical stimulation. So far, it's showing promise.

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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with retinitis pigmentosa.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Electro-acupuncture

2012

Completed Phase 1

~150

Laser Acupuncture

2022

N/A

~1090

Transcorneal Electrical Stimulation

2013

N/A

~180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor

89 Previous Clinical Trials

11,620 Total Patients Enrolled

National Eye Institute (NEI)NIH

546 Previous Clinical Trials

1,401,907 Total Patients Enrolled

23 Trials studying Retinitis Pigmentosa

14,350 Patients Enrolled for Retinitis Pigmentosa

Kenneth R Seger, OD, MScPrincipal InvestigatorFaculty

Media Library

Electro-acupuncture (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02086890 — N/A

Retinitis Pigmentosa Research Study Groups: Sham Electro-acupuncture, Electro-acupuncture, Sham Laser acupuncture, Sham Transcorneal Electrical Stimulation, Transcorneal Electrical Stimulation, Laser acupuncture

Retinitis Pigmentosa Clinical Trial 2023: Electro-acupuncture Highlights & Side Effects. Trial Name: NCT02086890 — N/A

Electro-acupuncture (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02086890 — N/A

Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT02086890 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to join this experiment?

"Clinicaltrials.gov corroborates that, as of May 6th 2022, this medical trial is no longer seeking participants. Originally posted on August 1st 2014 and last updated eight years later, it appears the study has fulfilled its recruitment quota. However, there are currently 51 other trials actively recruiting patients at this time for those interested in participating in clinical research."

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