Status:
COMPLETED
The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
Lead Sponsor:
McLaren Regional Medical Center
Collaborating Sponsors:
Kettering University
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
There is increasing acceptance that pain in fibromyalgia is a result of dysfunctional sensory processing in the spinal cord and brain. Electrical cortical stimulation is a device-based form of therapy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01180244
Start Date
January 1 2002
End Date
July 1 2008
Last Update
June 9 2014
Active Locations (1)
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1
McLaren Regional Medical Center
Flint, Michigan, United States, 48532