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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2025-12-31

Brief Summary

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

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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.

Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Electro-acupuncture

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham Electro-acupuncture

Intervention Type DEVICE

Laser acupuncture

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

Group Type EXPERIMENTAL

Laser Acupuncture

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type DEVICE

Transcorneal Electrical Stimulation

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

Group Type EXPERIMENTAL

Transcorneal Electrical Stimulation

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham transcorneal electrical stimulation

Intervention Type DEVICE

Interventions

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Electro-acupuncture

Intervention Type DEVICE

Laser Acupuncture

Intervention Type DEVICE

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Sham Electro-acupuncture

Intervention Type DEVICE

Sham laser acupuncture

Intervention Type DEVICE

Sham transcorneal electrical stimulation

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No