Overview

This trial is active, not recruiting.

Condition retinitis pigmentosa
Treatments electro-acupuncture, laser acupuncture, transcorneal electrical stimulation, sham electro-acupuncture, sham laser acupuncture, sham transcorneal electrical stimulation
Phase phase 1/phase 2
Sponsor Nova Southeastern University
Collaborator National Eye Institute (NEI)
Start date August 2014
End date June 2016
Trial size 21 participants
Trial identifier NCT02086890, 01311402F

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
electro-acupuncture
(Sham Comparator)
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
sham electro-acupuncture
(Experimental)
Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period
laser acupuncture
(Sham Comparator)
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
sham laser acupuncture
(Experimental)
Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions
transcorneal electrical stimulation
(Sham Comparator)
Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions
sham transcorneal electrical stimulation

Primary Outcomes

Measure
Significant Changes from baseline in Ocular and Retinal Blood Flow at 2 weeks and 6 weeks post-intervention initiation
time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Secondary Outcomes

Measure
Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation
time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Significant changes from baseline in multifocal electroretinogram (ERG) at both 2 weeks and 6 weeks post-intervention initiation
time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Significant changes from baseline in Goldmann visual field area at both 2 weeks and 6 weeks post-intervention initiation
time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation
time frame: 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
time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Optical Coherence Tomography (OCT)
time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Nova Southeastern University.