Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa

Study Overview
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Brief Summary
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Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.

Detailed Description
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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.

Official Title
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Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Device: Electro-acupuncture
* Device: Laser Acupuncture
* Device: Transcorneal Electrical Stimulation
* Device: Sham Electro-acupuncture
* Device: Sham laser acupuncture
* Device: Sham transcorneal electrical stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-acupuncture<br>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 | Device: Electro-acupuncture<br> <br> |
| Sham Comparator: Sham Electro-acupuncture<br>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 | Device: Sham Electro-acupuncture<br> <br> |
| Experimental: Laser acupuncture<br>Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period | Device: Laser Acupuncture<br> <br> |
| Sham Comparator: Sham Laser acupuncture<br>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 | Device: Sham laser acupuncture<br> <br> |
| Experimental: Transcorneal Electrical Stimulation<br>Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions | Device: Transcorneal Electrical Stimulation<br> <br> |
| Sham Comparator: Sham Transcorneal Electrical Stimulation<br>Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions | Device: Sham transcorneal electrical stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant changes from baseline in Goldmann visual field area in both eyes | Using Haig-Streit Octopus perimeter | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation | Using Pelli-Robson visual acuity charts | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | 
| Changes in Macular edema Optical Coherence Tomography (OCT) | Using Optical Coherence Tomography | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | 
| Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation | Using Adaptive Sensory Technology Quick CSF | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | 
| Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation | Using the AdaptDx by Maculogix | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinitis pigmentosa, acupuncture, electroacupuncture, transcorneal electrical stimulation, microcurrent