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

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ClinicalTrials.gov Identifier: NCT02086890
Recruitment Status : Active, not recruiting
First Posted : March 13, 2014
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ava Bittner, OD, PhD, Nova Southeastern University

Tracking Information
First Submitted Date  ICMJE March 10, 2014
First Posted Date  ICMJE March 13, 2014
Last Update Posted Date July 31, 2018
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02086890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa
Official Title  ICMJE Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE
  • Device: Electro-acupuncture
  • Device: Laser Acupuncture
  • Device: Transcorneal Electrical Stimulation
  • Device: Sham Electro-acupuncture
  • Device: Sham laser acupuncture
  • Device: Sham transcorneal electrical stimulation
Study Arms
  • 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Device: Sham transcorneal electrical stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2015)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2014)
24
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02086890
Other Study ID Numbers  ICMJE 01311402F
R21EY023720 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ava Bittner, OD, PhD, Nova Southeastern University
Study Sponsor  ICMJE Nova Southeastern University
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE Not Provided
PRS Account Nova Southeastern University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP