rTMS for the Treatment of Chronic Pain in GW1 Veterans

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT01608321

Run by

VA Office of Research and Development

People needed

17

Starts

2012-09-01

Expected to finish

2015-09-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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• Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increases the risk of having seizures.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

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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