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

NCT ID: NCT04046536

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gulf War Illness Depression

Keywords

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rTMS Transcranial Magnetic Stimulation Gulf War Illness Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be two groups: one will receive active rTMS and the other group will receive sham rTMS.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This is a double-blinded study where only the statistician is aware of the randomization

Study Groups

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Active rTMS at the LDLPFC

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

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

A non-invasive treatment that emits magnetic pulses to stimulate the brain.

Sham rTMS at the LDLPFC

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

Group Type SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.

Active rTMS at the LMC

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

A non-invasive treatment that emits magnetic pulses to stimulate the brain.

Sham rTMS at the LMC

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

Group Type EXPERIMENTAL

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.

Interventions

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Transcranial Magnetic Stimulation

A non-invasive treatment that emits magnetic pulses to stimulate the brain.

Intervention Type DEVICE

Sham Transcranial Magnetic Stimulation

Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Yick Leung, MD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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SPLD-013-18F

Identifier Type: -

Identifier Source: org_study_id

H190020

Identifier Type: OTHER

Identifier Source: secondary_id