rTMS for the Treatment of Chronic Pain in GW1 Veterans

Inclusion Criteria:

1. Born between 1936 and 1975 (ages 18 to 55 during Gulf War I) and were deployed to the Persian Gulf and participated as ground troops that entered Iraq or Kuwait territory.

2. Patients must have symptoms suggestive of Gulf War Illness, including

   - Chronic pain rated in the moderate to severe range on the MPQ which meets criteria for: 729.10 Fibromyalgia.

   - At least 2 other symptoms in the mood-cognition and/or fatigue categories of GWI as defined by the Fakuda et al. (1998) case definitions within the year after leaving the Gulf

3. Ability to obtain a Motor Threshold (MT) will be determined at the end of the screening process.
4. If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
5. Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.

6. For female participants, agrees to use one of the following acceptable methods of birth control:

   • Complete abstinence (not having sexual intercourse with anyone)
   • An oral contraceptive (birth control pills)
   • Norplant
   • Depo-Provera
   • A condom with spermicide
   • A cervical cap with spermicide
   • A diaphragm with spermicide
   • An Intrauterine device
   • Surgical sterilization (having your tubes tied)
7. Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments.

Exclusion Criteria:

1. Pregnant or lactating female (This is a Federal Drug Administration (FDA)-required exclusion. In the future, if rTMS becomes a proven treatment for pain, its safety in the context of pregnancy should be studied separately (Nahas et al 1999)).
2. Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increases the risk of having seizures.
3. Have a cardiac pacemaker.
4. Have an implanted device (deep brain stimulation) or metal in the brain.
5. Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
6. Known current psychosis as determined by Diagnostic and Statistical Manual (DSM-IV) coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
7. Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake interview)
8. Current amnesic disorders, dementia, Mini Mental Status Exam (MMSE) 24 or delirium.
9. Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by medical history, within 3 months prior to screening.
10. History of loss of consciousness greater than 15 minutes due to head injury.
11. Participation in another concurrent clinical trial.
12. Patients with prior exposure to rTMS.
13. Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial