Clinical trial NCT01608321: rTMS for the Treatment of Chronic Pain in GW1 Veterans
Official title: rTMS for the Treatment of Chronic Pain in GW1 Veterans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Chronic Pain
Gulf War Illness
Gulf War Syndrome
Fibromyalgia
repetitive Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-05-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind study of rTMS versus sham
Primary purpose: TREATMENT

Brief 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.

Detailed description: A number of studies have been conducted on the health of Veterans deployed to Iraq during GW1. The focus of these studies has been primarily to define the nature of symptoms and symptom clusters and to determine if evidence supports the definition of a new unique illness. Most noteworthy is the "Iowa Study", a cross-sectional study of 3,695 Veterans from Iowa consisting of those who were and were not deployed in GW1. In telephone interviews the Gulf War deployed Veterans reported approximately twice the number of symptoms compared to those who were not deployed.

The often ambiguous and seemingly treatment resistant symptoms presented by GW1 Veterans represent a challenge to the Veteran's Affairs Health Care System on two fronts; efficacy in treatment and cost. In particular, unlike most medical conditions which can be diagnosed by objective medical findings, pain is a subjective experience (International Association for the Study of Pain, 1994). Therefore the investigators propose to engage in a clinical trial of rTMS in chronic pain that occurs in the context of multiple medical symptoms in the GW1 population. The symptom category approach will be applied with the restriction that enrolled GWI diagnosed patients will have symptoms of chronic pain as outlined in the musculoskeletal category and at least two additional symptoms.

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

Primary outcomes:
measure: Change in the Brief Pain Inventory (Short Form) Score
timeFrame: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: John W Ashford, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: