The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
Completed · Not applicable · Has a placebo group
Conditions studied: Fibromyalgia
In brief
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.
Key facts
- Study ID
- NCT01180244
- Run by
- McLaren Regional Medical Center
- People needed
- 91
- Starts
- 2002-01-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2014-06-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 through 65 years
- An ability to read and comprehend English
- Completion of a minimum of grade 8 education
- Diagnosis of fibromyalgia in 1999 or earlier, by a rheumatologist or appropriate specialist, and currently meeting the American College of Rheumatology 1990 criteria
- Symptoms for at least 48 months with no recent remission of symptoms to any degree
You may not qualify if…
- Developmental disabilities, or significant psychological disorder (except depression and anxiety disorders) for which treatment has become necessary
- A history of chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's Disease, multiple sclerosis, hepatitis, history of meningo-encephalitis, polio, seizures, or metastatic cancer
- Current pregnancy, or plans to become pregnant during the study period.
- Any other condition deemed to pose a risk to the patient at the discretion of the investigators
- Exposure to other neurostimulation systems, or electroconvulsive therapy
- Any implantable electronic device
- Any present or previous litigation regarding their physical condition
Where it is running
- McLaren Regional Medical Center — Flint, Michigan, United States
Full record on ClinicalTrials.gov
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