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

• Number of positive tender points [ Time Frame: Total timeframe 13 weeks: 11 weeks of treatment with outcome assessed within 14 days following end of treatment ] [ Designated as safety issue: No ]
  The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations
• Change in Fibromyalgia Impact Questionnaire overall score [ Time Frame: Total timeframe 13 weeks: 11 weeks of treatment with outcome assessed within 14 days following end of treatment ] [ Designated as safety issue: No ]
• Change in Fibromyalgia Impact Questionnaire pain visual analog scale [ Time Frame: Total timeframe 13 weeks: 11 weeks of treatment with outcome assessed within 14 days following end of treatment ] [ Designated as safety issue: No ]
• Change in Fibromyalgia Impact Questionnaire sleep satisfaction visual analog scale [ Time Frame: Total timeframe 13 weeks: 11 weeks of treatment with outcome assessed within 14 days following end of treatment ] [ Designated as safety issue: No ]

• Number of positive tender points [ Time Frame: Within 14 days following end of treatment ] [ Designated as safety issue: No ]
  The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations
• Change in Fibromyalgia Impact Questionnaire overall score [ Time Frame: Within 14 days following end of treatment ] [ Designated as safety issue: No ]
• Change in Fibromyalgia Impact Questionnaire pain visual analog scale [ Time Frame: Within 14 days following end of treatment ] [ Designated as safety issue: No ]
• Change in Fibromyalgia Impact Questionnaire sleep satisfaction visual analog scale [ Time Frame: Within 14 days following end of treatment ] [ Designated as safety issue: No ]

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.

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 that is increasingly being considered as an adjuvant to current medical modalities for the treatment of chronic pain conditions such as fibromyalgia. The investigators propose that stimulation of cortical areas believed to be involved in dysfunctional sensory processing may have a beneficial influence on fibromyalgia symptoms.

The aim of this randomized double blind, placebo controlled study is to evaluate the efficacy, safety, and tolerability of noninvasive cortical stimulation in the management of fibromyalgia symptoms. More specifically, an active treatment group of subjects will receive the study's cortical stimulation protocol twice a week for 11 weeks and will be evaluated within 14 days following end of treatment, for a total timeframe of 13 weeks. In comparison, a similar group of subjects will receive the same treatment protocol without the actual stimulation signal being applied. The signal utilized is a modulated form that permits very low-intensity signals to pass through outer tissues with less attenuation due to tissue impedance. The signals are of a sufficiently low strength that they are below the level of perception. Hence subjects cannot feel the signal, and are therefore blinded to treatment arm. Investigators and clinical staff are also blinded. Outcome measures include post-treatment to baseline changes in tender points, sleep characteristics as measured by visual analog scales, and outcomes instruments including the Fibromyalgia Impact Questionnaire.

• 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.
  Other Name: NeuroPoint
• 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.
  Other Name: NeuroPoint

• Active Comparator: Active treatment
  Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
  Intervention: Device: Noninvasive cortical electrical stimulation
• Placebo Comparator: Placebo group
  Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
  Intervention: Device: Sham treatment

Inclusion Criteria:

• 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 Criteria:

• 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