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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

NCT00928720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-07-03

Study results available
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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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

CES device

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.

DEVICE

sham device

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

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Ann G Taylor, EdD, RN · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928720 on ClinicalTrials.gov