CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
Noninvasive cortical electrical stimulation +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/NCT01180244
NCT01180244N/ACompleted
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The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients

McLaren Regional Medical Center·interventional·Posted Aug 12, 2010·Updated Jun 9, 2014

In Brief

A clinical study evaluating Noninvasive cortical electrical stimulation and Sham treatment for Fibromyalgia. Completed, enrolled 91 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether persons treated with a low-intensity, noninvasive form of cortical electrical stimulation experience a reduction in symptoms of fibromyalgia different than persons receiving a sham treatment. Outcome measures include reduction in patient pain levels and improvement in sleep measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsKettering University

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2010
Enrollment StartJan 1, 2002
Primary CompletionJan 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 15.9 years ago

Interventions

Noninvasive cortical electrical stimulationdevice

Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.

Sham treatmentdevice

Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.