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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia - NCT00928720-22908(Clinical Trial 299900)



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City:  Charlottesville
State:  
VA
Zip Code: 22908
Conditions: Fibromyalgia
Purpose: 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 with fibromyalgia.
Study summary: 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 symptoms of FM by interacting with the central pain networks. The specific aims of this randomized, controlled, three-group pilot study design are to: (1) determine differences in pain over time between the active CES, sham device, and usual care (UC) groups; (2) explore differences in brain activity in pain processing regions (i.e., cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the active CES, sham device, and UC groups in a subset of 12 participants (6 in each device group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances, depression, perceived stress) and functional status, and blood pressure over time between the active CES, sham device, and UC groups; and (4) determine the amount of influence that selected psychological factors (negative affect, catastrophizing, and other personality characteristics) have on group differences in pain, other symptoms, functional status, and brain activity.
Criteria: 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)
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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