Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain
Condition: Fibromyalgia; Chronic Pain; Depression
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain; Depression
Intervention: rTMS; Sham rTMS
Intervention description: 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex; 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Fatigue; Chronic Fatigue Syndrome; Chronic Fatigue-Fibromyalgia Syndrome; Depression; Major Depressive Disorder

Summary:

      While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of
      time, chronic pain persists and can continue for months and even years. Repetitive
      transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the
      brain and can affect brain activity. The purpose of this study is to determine the
      effectiveness of rTMS treatment in reducing chronic widespread pain in women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic widespread pain as defined by the 1990 American College of
             Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain
             above and below the waist; pain on both right and left sides; pain at one axial site
             (e.g., head, neck, spine, or back)

          -  Willing to remain on a stable medical regimen during the entire 6-week course of Phase
             1 treatment and 8 weeks prior to rTMS treatment

          -  Willing to undergo random assignment and able to attend treatment sessions

          -  Willing to remain on a stable psychotherapy regimen if currently receiving
             psychotherapy that has been ongoing for at least 3 months prior to study entry

        Exclusion Criteria:

          -  Unable to maintain treatment as usual at stable doses for any medical or psychiatric
             conditions for 8 weeks prior to and during the study

          -  Another medical condition associated with significant pain (e.g., diabetic neuropathy,
             systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative joint disease)

          -  Any condition that might increase the risk of seizures from TMS

          -  History of a seizure disorder or family history of a seizure disorder

          -  Previous use of TMS

          -  Involvement in litigation or disability that is related to fibromyalgia, chronic
             widespread pain, or depression

          -  Current use of proconvulsant medications (e.g., bupropion)

          -  Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g.,
             aneurysm clips, pacemakers, neurostimulators)

          -  History of head injury associated with loss of consciousness for more than 15 minutes,
             brain surgery, or lithium toxicity

          -  History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic
             disorder, or post-traumatic stress disorder

          -  Current substance abuse or dependence

          -  Active suicidal intent or plan

          -  Severe claustrophobia that would prevent MRI

          -  Major depression with psychotic features or a current major depressive episode lasting
             longer than 5 years

          -  Pregnant