rTMS for the Treatment of Chronic Pain in GW1 Veterans (rTMS)

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Device: rTMS; Device: Sham device

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1290
      • VA Palo Alto Health Care System, Palo Alto, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: rTMS; Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.	Device: rTMS; Repetitive Transcranial Magnetic Stimulation
PLACEBO_COMPARATOR: Sham rTMS; Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.	Device: Sham device; Placebo Device that simulates active rTMS treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Brief Pain Inventory (Short Form) Score	The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.	Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: John W Ashford, MD PhD, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: May 25, 2012
• First Posted (ESTIMATE): May 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Pain; Veterans; Gulf War Syndrome; Gulf War Illness; Transcranial Magnetic Stimulation; Fibromyalgia; repetitive Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: SPLD-001-11F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Trial discontinued before an adequate number of subjects was tested.