Status:
COMPLETED
Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Lead Sponsor:
University of Virginia
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effects of mild cranial electrical stimulation on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status in persons wi...
Detailed Description
Central pain networks in the brain are dysregulated in persons with fibromyalgia (FM). Thus, the investigators propose that cranial electrical stimulation (CES) that works on the brain may ameliorate ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- meet the diagnostic criteria for FM established by the American College of Rheumatology
- have initial pain level equal to or greater than 3 on a NRS 0-10
- have stable medication use related to FM for at least 4 weeks
- be able to read, write, and understand the English language
- Exclusion Criteria (all participants):
- pregnant or breastfeeding
- epilepsy or history of seizures
- presence of pacemakers and/or other implanted devices
- Exclusion Criteria (subset of 12 participants who wil have fMRIs):
- conditions that would not permit an fMRI (e.g., certain types of metal or metallic objects in body, diaphragm or intrauterine device, dermal patches, ear or eye implants, implanted electrical stimulators, artificial heart valve, implanted catheter or tube, tattoos, claustrophobia; or weight more than 275 lbs)
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00928720
Start Date
June 1 2009
End Date
October 1 2010
Last Update
July 3 2018
Active Locations (1)
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1
University of Virginia Center for the Study of Complementary and Alternative Therapies
Charlottesville, Virginia, United States, 22908