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Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for the Treatment of Vision Loss Due to Retinitis Pigmentosa

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ava Bittner, OD, PhD, Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT02086890
First received: March 10, 2014
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention 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 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ava Bittner, OD, PhD, Nova Southeastern University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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 ]
    changes in macular edema


Estimated Enrollment: 21
Study Start Date: August 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086890

Locations
United States, Florida
Nova Southeastern University; College of Optometry
Ft. Lauderdale, Florida, United States, 33328
Sponsors and Collaborators
Nova Southeastern University
National Eye Institute (NEI)
  More Information

Publications:
Responsible Party: Ava Bittner, OD, PhD, Associate Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02086890     History of Changes
Other Study ID Numbers: 01311402F
Study First Received: March 10, 2014
Last Updated: April 6, 2017

Keywords provided by Ava Bittner, OD, PhD, Nova Southeastern University:
retinitis pigmentosa
acupuncture
electroacupuncture
transcorneal electrical stimulation
microcurrent

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 22, 2017