rTMS for the Treatment of Chronic Pain in GW1 Veterans
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: rTMS; Sham device
Intervention description: Repetitive Transcranial Magnetic Stimulation; Placebo Device that simulates active rTMS treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind study of rTMS versus sham
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: rTMS sham involves using the same paddle applied to the head, the side (one shielded internally from the magnetic pulse by aluminum) turned toward the head is randomized. A small shock is also given in both circumstances to disguise the sensation produced by the active rTMS.
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Pain; Gulf War Illness; Gulf War Syndrome; Fibromyalgia; repetitive Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation; Veterans

Summary:

      This study was designed to evaluate the effect of repetitive Transcranial Magnetic
      Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the
      first Gulf War (GW1) who often suffer from chronic pain problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Born between 1936 and 1973 (ages 18 to 55 during Gulf War I) and were deployed to the
             Persian Gulf during Gulf War I.

          -  Patients must have symptoms suggestive of Gulf War Illness, including

               -  Chronic pain >= 4 on the pain severity scale of the BPI-SF at screening

               -  At least 2 other symptoms in at least one of the other five (5) categories
                  defined by the 2013 IOM report (Gulf War and Health, Treatment for Chronic
                  Multisymptom Illness): fatigue, mood and cognition, gastrointestinal,
                  respiratory, and neurological

          -  Ability to obtain a Motor Threshold (MT) will be determined at the end of the
             screening process.

          -  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.

          -  Has an adequately stable condition and environment to enable attendance at scheduled
             clinic visits.

          -  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)

          -  Able to read, verbalize understanding and voluntarily sign the Informed Consent Form
             prior to performance of any study-specific procedures or assessments.

        Exclusion Criteria:

          -  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)).

          -  Unable to be safely withdrawn, at least two-weeks prior to treatment commencement,
             from medications that substantially increases the risk of having seizures.

          -  Have a cardiac pacemaker.

          -  Have an implanted device (deep brain stimulation) or metal in the brain.

          -  Have a mass lesion, cerebral infarct or other active central nervous system (CNS)
             disease, including a seizure disorder.

          -  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.

          -  Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake
             interview)

          -  Current amnesic disorders, dementia, Mini Mental Status Exam (MMSE) 24 or delirium.

          -  Current substance abuse (not including caffeine or nicotine) as determined by positive
             toxicology screen, or by medical history, within 3 months prior to screening.

          -  History of loss of consciousness greater than 15 minutes due to head injury.

          -  Participation in another concurrent clinical trial.

          -  Patients with prior exposure to rTMS.

          -  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