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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086890
Recruitment Status : Active, not recruiting
First Posted : March 13, 2014
Last Update Posted : June 8, 2023
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Kenneth Seger, Nova Southeastern University

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

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Electro-acupuncture Device: Laser Acupuncture Device: Transcorneal Electrical Stimulation Device: Sham Electro-acupuncture Device: Sham laser acupuncture Device: Sham transcorneal electrical stimulation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: Electro-acupuncture
Sham Comparator: 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
 Device: Sham Electro-acupuncture
Experimental: Laser acupuncture
Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period
 Device: Laser Acupuncture
Sham Comparator: 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
 Device: Sham laser acupuncture
Experimental: Transcorneal Electrical Stimulation
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
Sham Comparator: 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
 Device: Sham transcorneal electrical stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Significant changes from baseline in Goldmann visual field area in both eyes [ Time Frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation ]
    Using Haig-Streit Octopus perimeter


Secondary Outcome Measures :
  1. 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 ]
    Using Pelli-Robson visual acuity charts

  2. Changes in Macular edema Optical Coherence Tomography (OCT) [ Time Frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation ]
    Using Optical Coherence Tomography

  3. 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 ]
    Using Adaptive Sensory Technology Quick CSF

  4. 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 ]
    Using the AdaptDx by Maculogix


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086890


Locations
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United States, Florida
Nova Southeastern University; College of Optometry
Fort Lauderdale, Florida, United States, 33328
Sponsors and Collaborators
Nova Southeastern University
National Eye Institute (NEI)
Investigators
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Principal Investigator: Kenneth R Seger, OD, MSc Faculty
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Kenneth Seger, Associate Professor, HPD-College of Optometry, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02086890    
Other Study ID Numbers: 01311402F
R21EY023720 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: June 8, 2023
Last Verified: June 2023
Keywords provided by Kenneth Seger, Nova Southeastern University:
retinitis pigmentosa
acupuncture
electroacupuncture
transcorneal electrical stimulation
microcurrent
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn