Your session is about to expire
← Back to Search
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 belowSelect...
You have been diagnosed with retinitis pigmentosa (RP).
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
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with retinitis pigmentosa (RP).You have received acupuncture or TES treatment for RP in the past.You have trouble understanding the study procedures or communicating your responses consistently due to a cognitive impairment.You have dementia or problems with your long or short-term memory.You have a heart pacemaker implanted.You are pregnant.You have very severe vision loss in both eyes, which makes it hard for you to perform the vision tests required for the study.You have lost vision due to eye diseases that are not related to RP, cystoid macular edema, or cataracts.You use tobacco, drink a lot of alcohol, or take illegal drugs.You have a history of bleeding too much.You have a medical condition or take medications that might make it harder for the electroacupuncture treatment to work.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Electro-acupuncture
- Group 2: Sham Laser acupuncture
- Group 3: Transcorneal Electrical Stimulation
- Group 4: Sham Transcorneal Electrical Stimulation
- Group 5: Electro-acupuncture
- Group 6: Laser acupuncture
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Share this study with friends
Copy Link
Messenger