Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms

Veterans Medical Research Foundation

Status: Enrolling

Conditions: Gulf War Illness; Gulf War Syndrome; Joint Pain; Muscle Pain; Headache

Treatments: Device: Sham Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04182659

H190071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Active rTMS at the LMC

Active Comparator group

Description:

Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)

Treatment:

Device: Transcranial Magnetic Stimulation

Sham rTMS at the LMC

Sham Comparator group

Description:

Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC.

Treatment:

Device: Sham Transcranial Magnetic Stimulation