Clinical trial NCT04182659: Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
Official title: Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gulf War Syndrome
Gulf War Illness
Headache
Muscle Pain
Joint Pain
Keywords: rTMS
Transcranial Magnetic Stimulation
Gulf War Illness
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups: one will receive active rTMS and the other group will receive sham rTMS.
Primary purpose: TREATMENT

Brief summary: This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.

Detailed description: Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating headaches, muscle, and joint pain symptoms of GWI.

Eligibility criteria: Inclusion Criteria:

* Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region
* Center for Disease Control (CDC) Criteria for Gulf War Illness (GWI)
* Kansas Criteria for GWI
* International Headache Society Criteria for Migraine Headache without aura Average Headache Exacerbation Intensity \>3 on 0-10 a Numerical Pain Rating scale (NPS)
* Average Overall Daily Muscle Pain Intensity \>3 on 0-10 a NPS
* Average Overall Daily Extremities Joint Pain Intensity \>3 on 0-10 a NPS
* Headache Exacerbation/attack 3 times per week with the average intensity \>3 on a 0-10 NPS, lasting \> 4 hours in the past three months
* Hamilton Rating Scale of Depression (HRSD) \<14 based on the sum of scores for the first 17 items

Exclusion Criteria:

* Pregnancy
* History of pacemaker implant
* Any ferromagnetic (e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
* History of dementia, major psychiatric diseases, or life-threatening diseases
* Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy
* History of seizure
* Pending litigation
* Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy
* Lack of ability to understand the experimental protocol and to adequately communicate in English
* History of Traumatic Brain injury
* Chronic Tension or Cluster Headache
* Ongoing Cognitive Rehabilitation or Treatment of PTSD

Primary outcomes:
measure: Change from baseline to post treatment of GWI-related pain and headaches
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of sensory and affective aspects of pain
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of headaches
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of quality of life
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of body pain
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of muscle pain
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of fibromyalgia
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of neurobehavioral symptoms
timeFrame: The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
measure: Change from baseline to post treatment of sleep quality
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of sleep difficulties
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change from baseline to post treatment of fatigue
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
Secondary outcomes:
measure: Change from baseline to post treatment of PTSD symptoms
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Change in opioid-based pain medication usage
timeFrame: Baseline, 1-week, 1-month, 2-month, and 3-month
measure: Explore changes in supraspinal resting state functional connectivity
timeFrame: Baseline and 1-week post treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Decatur
country: United States
facility: VA Atlanta
state: Georgia
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Albert Leung, M.D.
role: PRINCIPAL_INVESTIGATOR
References: