Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain
Condition: Fibromyalgia; Chronic Pain; Depression
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain; Depression
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Chronic widespread pain is characterized by musculoskeletal pain that lasts for at least 3
      months, pain above and below the waist, pain on both the right and left sides, and pain in
      the head, neck, spine, or back. In addition to fatigue, chronic widespread pain is a hallmark
      feature of fibromyalgia. Significant physical and emotional effects usually accompany chronic
      widespread pain and fibromyalgia, making the development of effective treatments a priority.
      rTMS involves a neurophysiologic technique that directs a current into the brain by using a
      magnetic field to pass the scalp and skull safely and painlessly. Stimuli are applied to the
      same brain area several times per second during several consecutive seconds. rTMS has been
      found to be effective for treating certain types of chronic pain. The purpose of this study
      is to determine the effectiveness of rTMS treatment in reducing bodily pain associated with
      chronic widespread pain and/or fibromyalgia in women.

      Participants in this study will undergo a diagnostic interview, physical and neurological
      exam, electrocardiogram, magnetic resonance imaging, and blood and urine collection for
      screening purposes. Eligible participants will then be randomly assigned to receive either
      rTMS treatment or sham rTMS treatment. One-hour daily treatment sessions will occur over 15
      days. After every five treatment sessions, participants will be interviewed about their pain
      and depression symptoms, and they will fill out questionnaires about pain, depression,
      fatigue, sleep, and exercise. Participants will also undergo pain threshold and tolerance
      testing of their right thumb. On a daily basis, participants will rate their level of pain
      using a 0 to 20 scale. Follow-up evaluations will occur 1, 4, and 12 weeks after treatment
      and will include a repeat interview and testing. After the follow-up evaluations, any
      participants who did not respond to the sham treatment will be offered a series of 15 real
      rTMS treatment sessions.
    

Intervention name(s): rTMS; Sham rTMS
Intervention type(s): Device; Device
Intervention description(s): 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
Other intervention name(s): Neuronetics 2100 CRS rTMS System; Neuronetics 2100 rTMS and James Long Integrated Sham System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Fatigue; Chronic Fatigue Syndrome; Chronic Fatigue-Fibromyalgia Syndrome; Depression; Major Depressive Disorder