rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)

VA Office of Research and Development

Status: Completed

Conditions: Gulf War Illness; Depression

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04046536

H190020 (Other Identifier)

SPLD-013-18F

Details and patient eligibility

About

This study aims to look at the effectiveness of using repetitive transcranial magnetic stimulation (rTMS) in relieving pain and other co-morbid symptoms of Gulf War Illness.

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). Likewise, depression carries a very high co-morbid rate (50%) in patients with chronic pain, and in GWV with GWI related chronic HA and body muscle and joint pain conditions (GWI-HAP). 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 pain and other co-morbid symptoms of GWI.

Enrollment: 204 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
• CDC Criteria for GWVI (GWI)
• Kansas Criteria for GWVI (GWI)
• International Headache Society Criteria for Migraine Headache without aura
• 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 once a week with the average intensity >3 on a 0-10 NPS, lasting > 1 hour in the past three months
• Hamilton Rating Scale of Depression (HRSD) greater than or equal to 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

---

204 participants in 4 patient groups

Active rTMS at the LDLPFC

Active Comparator group

Description:

Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC).

Treatment:

Device: Transcranial Magnetic Stimulation

Sham rTMS at the LDLPFC

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 LDLPFC.

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Active rTMS at the LMC

Experimental 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

Experimental 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