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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
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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uptwice 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.

Eligible Conditions
  • Retinitis Pigmentosa

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with retinitis pigmentosa (RP).

Timeline

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
Transcorneal Electrical Stimulation
2013
N/A
~180
Laser Acupuncture
2012
N/A
~1030

Find a Location

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor
86 Previous Clinical Trials
11,429 Total Patients Enrolled
National Eye Institute (NEI)NIH
535 Previous Clinical Trials
1,197,937 Total Patients Enrolled
23 Trials studying Retinitis Pigmentosa
14,385 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, Sham Laser acupuncture, Transcorneal Electrical Stimulation, Sham Transcorneal Electrical Stimulation, Electro-acupuncture, 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."

Answered by AI

Who else is applying?

What state do they live in?
California
Other
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Nova Southeastern University; College of Optometry
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm trying my best to get my eyesight back, to see the beauty of the world again.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Retnist pigmentosa is treatable in future ?
PatientReceived 2+ prior treatments
Recent research and studies
~2 spots leftby Dec 2024