Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa
Not Applicable
Active, not recruiting
- Conditions
- Retinitis Pigmentosa
- Interventions
- Device: Sham transcorneal electrical stimulationDevice: Electro-acupunctureDevice: Sham laser acupunctureDevice: Laser AcupunctureDevice: Transcorneal Electrical StimulationDevice: Sham Electro-acupuncture
- Registration Number
- NCT02086890
- Lead Sponsor
- Nova Southeastern University
- Brief Summary
Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.
- Detailed Description
Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no proven treatment. Patients are interested in trying alternative therapies to try to reduce their vision loss, but only limited research evidence exists to support their use and potential benefit. The goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in RP patients receiving two promising therapies, electroacupuncture and transcorneal electrical stimulation. We are currently only doing transcorneal electrical stimulation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Age 18+
- Diagnosis of retinitis pigmentosa (RP)
- 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
- Able and willing to participate in all study visits for a ~4-6 month period
- Provide informed consent
Exclusion Criteria
- Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests
- Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts
- Schedules do not permit participation in all study visits
- Previous acupuncture or TES treatment for RP
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
- Dementia; Long or short-term memory loss
- Unable to read or speak English
- Smoking, excessive alcohol, or illegal drug use
- Receiving current psychiatric care (i.e. unstable emotional and mental health status)
- History of excessive bleeding
- Reduced general health and/or systemic medications that may diminish the potential response to the electroacupuncture treatments
- Implanted cardiac pacemaker
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sham Transcorneal Electrical Stimulation Sham transcorneal electrical stimulation Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions Electro-acupuncture Electro-acupuncture 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 Sham Laser acupuncture Sham laser acupuncture 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 Laser acupuncture Laser Acupuncture Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period Transcorneal Electrical Stimulation Transcorneal Electrical Stimulation Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions Sham Electro-acupuncture Sham Electro-acupuncture 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
- Primary Outcome Measures
Name Time Method Significant changes from baseline in Goldmann visual field area in both eyes twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation Using Haig-Streit Octopus perimeter
- Secondary Outcome Measures
Name Time Method Changes in Macular edema Optical Coherence Tomography (OCT) twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation Using Optical Coherence Tomography
Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation Using Adaptive Sensory Technology Quick CSF
Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation Using Pelli-Robson visual acuity charts
Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation Using the AdaptDx by Maculogix
Trial Locations
- Locations (1)
Nova Southeastern University; College of Optometry
🇺🇸Fort Lauderdale, Florida, United States