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

Nova Southeastern University (NSU)

Status: Active, not recruiting

Conditions: Retinitis Pigmentosa

Treatments: Device: Sham transcorneal electrical stimulation; Device: Sham laser acupuncture; Device: Electro-acupuncture; Device: Transcorneal Electrical Stimulation; Device: Laser Acupuncture; Device: Sham Electro-acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02086890

01311402F

R21EY023720 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 6 patient groups

Electro-acupuncture

Experimental group

Description:

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

Treatment:

Device: Electro-acupuncture

Sham Electro-acupuncture

Sham Comparator group

Description:

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

Treatment:

Device: Sham Electro-acupuncture

Laser acupuncture

Experimental group

Description:

Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period

Treatment:

Device: Laser Acupuncture

Sham Laser acupuncture

Sham Comparator group

Description:

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

Treatment:

Device: Sham laser acupuncture

Transcorneal Electrical Stimulation

Experimental group

Description:

Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions

Treatment:

Device: Transcorneal Electrical Stimulation

Sham Transcorneal Electrical Stimulation

Sham Comparator group

Description:

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:

Device: Sham transcorneal electrical stimulation