Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS

Headaches (HA) and wide spread pain are some of the most common debilitating symptoms in Gulf
War Veterans (GWV) with Gulf War Illness (GWI). Migraine like HA and diffuse body pain were
detected in 64% of GWV with GWI. This high prevalence of chronic HA and diffuse body pain
conditions are often associated with neuropsychological dysfunction in mood, attention,
memory and other systemic symptoms, which cast a profound negative impact on patients'
quality of life. Unfortunately, conventional pharmacological treatments for GWI related
headaches and pain (GWI-HAP) has not been shown to be effective and drugs such as narcotics
contain many long term untoward psychosomatic and abusive side effects. Therefore, developing
and validating non-invasive and low risk innovative treatment for this patient population is
warranted. Transcranial Magnetic Stimulation (TMS) is currently a US FDA approved treatment
for major depression and migraine HA.

Criteria for veterans with Gulf War Illness headaches and pain:

Inclusion Criteria:

- Male or female between ages 18-65

- CDC Criteria for GWI

- Kansas Criteria for GWI

- International Headache Society Criteria for Migraine HA w/o aura

- Average Headache Exacerbation Intensity >3 on 0-10 NPRS

- Average Overall Daily Muscle Pain Intensity >3 on 0-10 NPRS

- Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 NPRS

- Headache Exacerbation/Attack ≥ 3 times/week, lasting >4 hrs in past 3 months

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

Criteria for healthy veterans without Gulf War Illness headaches and pain:

Inclusion Criteria:

- Male or female between ages 18-65

- Served at least 30 consecutive days in the Persian Gulf between 8/90-7/91

Exclusion Criteria:

- CDC Criteria for GWI

- Kansas Criteria for GWI

- International Headache Society Criteria for Migraine HA w/o aura

- Average Headache Exacerbation Intensity >3 on 0-10 NPRS

- Average Overall Daily Muscle Pain Intensity >3 on 0-10 NPRS

- Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 NPRS

- Headache Exacerbation/Attack ≥ 3 times/week, lasting >4 hrs in past 3 months

- 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