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

Primary Purpose

Retinitis Pigmentosa

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electro-acupuncture

Laser Acupuncture

Transcorneal Electrical Stimulation

Sham Electro-acupuncture

Sham laser acupuncture

Sham transcorneal electrical stimulation

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa, acupuncture, electroacupuncture, transcorneal electrical stimulation, microcurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nova Southeastern University; College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Electro-acupuncture

Sham Electro-acupuncture

Laser acupuncture

Sham Laser acupuncture

Transcorneal Electrical Stimulation

Sham Transcorneal Electrical Stimulation

Arm Description

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

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

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

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

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

Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions

Outcomes

Primary Outcome Measures

Significant changes from baseline in Goldmann visual field area in both eyes

Using Haig-Streit Octopus perimeter

Secondary Outcome Measures

Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation

Using Pelli-Robson visual acuity charts

Changes in Macular edema Optical Coherence Tomography (OCT)

Using Optical Coherence Tomography

Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation

Using Adaptive Sensory Technology Quick CSF

Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation

Using the AdaptDx by Maculogix

Full Information

NCT ID

NCT02086890

First Posted

March 10, 2014

Last Updated

June 6, 2023

Sponsor

Nova Southeastern University

Collaborators

National Eye Institute (NEI)

1. Study Identification

Unique Protocol Identification Number

NCT02086890

Brief Title

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

Official Title

Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2014 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Southeastern University

Collaborators

National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

Keywords

retinitis pigmentosa, acupuncture, electroacupuncture, transcorneal electrical stimulation, microcurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electro-acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Electro-acupuncture

Arm Type

Sham Comparator

Arm Description

Arm Title

Laser acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Laser acupuncture

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Transcorneal Electrical Stimulation

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Transcorneal Electrical Stimulation

Arm Type

Sham Comparator

Arm Description

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 Type

Device

Intervention Name(s)

Electro-acupuncture

Intervention Type

Device

Intervention Name(s)

Laser Acupuncture

Intervention Type

Device

Intervention Name(s)

Transcorneal Electrical Stimulation

Intervention Type

Device

Intervention Name(s)

Sham Electro-acupuncture

Intervention Type

Device

Intervention Name(s)

Sham laser acupuncture

Intervention Type

Device

Intervention Name(s)

Sham transcorneal electrical stimulation

Primary Outcome Measure Information:

Title

Significant changes from baseline in Goldmann visual field area in both eyes

Description

Using Haig-Streit Octopus perimeter

Time Frame

twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Secondary Outcome Measure Information:

Title

Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation

Description

Using Pelli-Robson visual acuity charts

Time Frame

twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Title

Changes in Macular edema Optical Coherence Tomography (OCT)

Description

Using Optical Coherence Tomography

Time Frame

twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Title

Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation

Description

Using Adaptive Sensory Technology Quick CSF

Time Frame

twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Title

Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation

Description

Using the AdaptDx by Maculogix

Time Frame

twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth R Seger, OD, MSc

Organizational Affiliation

Faculty

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nova Southeastern University; College of Optometry

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33328

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24773463

Citation

Bittner AK, Gould JM, Rosenfarb A, Rozanski C, Dagnelie G. A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients. Clin Exp Optom. 2014 May;97(3):240-7. doi: 10.1111/cxo.12117. Epub 2013 Oct 29.

Results Reference

background

PubMed Identifier

29222719

Citation

Bittner AK, Seger K. Longevity of visual improvements following transcorneal electrical stimulation and efficacy of retreatment in three individuals with retinitis pigmentosa. Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):299-306. doi: 10.1007/s00417-017-3858-8. Epub 2017 Dec 8.

Results Reference

result

PubMed Identifier

29130647

Citation

Bittner AK, Seger K, Salveson R, Kayser S, Morrison N, Vargas P, Mendelsohn D, Han J, Bi H, Dagnelie G, Benavente A, Ramella-Roman J. Randomized controlled trial of electro-stimulation therapies to modulate retinal blood flow and visual function in retinitis pigmentosa. Acta Ophthalmol. 2018 May;96(3):e366-e376. doi: 10.1111/aos.13581. Epub 2017 Nov 11.

Results Reference

result

PubMed Identifier

28910168

Citation

Kayser S, Vargas P, Mendelsohn D, Han J, Bi H, Benavente A, Bittner AK. Reduced Central Retinal Artery Blood Flow Is Related to Impaired Central Visual Function in Retinitis Pigmentosa Patients. Curr Eye Res. 2017 Nov;42(11):1503-1510. doi: 10.1080/02713683.2017.1338350. Epub 2017 Sep 14.

Results Reference

result

Learn more about this trial

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

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