MedTrace Logo

The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients

NCT01180244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2014-06-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Noninvasive cortical electrical stimulation

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.

DEVICE

Sham treatment

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.

Sponsors & Collaborators

  • Kettering University

    collaborator OTHER

  • McLaren Regional Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey B Hargrove, PhD · Kettering University

  • Susan J Smith, MD · McLaren Regional Medical Center

  • Sunil Nagpal, MD · McLaren Regional Medical Center

  • David G Simons, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2008-01-31
Completion
2008-07-31

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 NCT01180244 on ClinicalTrials.gov