Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00524420
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00524420
Study Brief:
Protocol Section:
NCT00524420