Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS

Veterans Medical Research Foundation

Status: Completed

Conditions: Gulf War Syndrome; Headache

Treatments: Device: Repetitive transcranial magnetic stimulation; Device: Repetitive transcranial magnetic stimulation (sham)

Study type: Interventional

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

Identifiers

NCT03030794

H160047

Details and patient eligibility

About

This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 2 patient groups, including a placebo group

Repetitive TMS

Active Comparator group

Description:

Subjects will receive the repetitive transcranial magnetic stimulation study procedure.

Treatment:

Device: Repetitive transcranial magnetic stimulation

No (blocked) repetitive TMS

Placebo Comparator group

Description:

Subjects will not receive the repetitive transcranial magnetic stimulation study procedure by blocking the stimulation between the coil and the head, but the audiovisual conditions will be mimicked.

Treatment:

Device: Repetitive transcranial magnetic stimulation (sham)