CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
CES device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00928720
NCT00928720N/ACompleted
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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

University of Virginia·interventional·Posted Jun 26, 2009·Updated Jul 3, 2018

In Brief

A clinical study evaluating CES device and sham device for Fibromyalgia. Completed, enrolled 57 participants across 1 site.

Detailed 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 with fibromyalgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.0 years ago

Interventions

CES devicedevice

Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.

sham devicedevice

The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.