Gulf War IllnessNCT04046536
rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)
A study testing Transcranial Magnetic Stimulation in people with Gulf War Illness and Depression, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gulf War Illness, Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2019to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI
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.
Read the detailed 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.
- Conditions
- Gulf War Illness, Depression
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- rTMS, Transcranial Magnetic Stimulation, Gulf War Illness, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
A non-invasive treatment that emits magnetic pulses to stimulate the brain.
Sham Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS at the LDLPFC | Active comparator | Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC). Receives: Device: Transcranial Magnetic Stimulation |
| Sham rTMS at the LDLPFC | Sham comparator | Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LDLPFC. Receives: Device: Sham Transcranial Magnetic Stimulation |
| Active rTMS at the LMC | Experimental | Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC) Receives: Device: Transcranial Magnetic Stimulation |
| Sham rTMS at the LMC | Experimental | Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC. Receives: Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to post treatment of GWI-related pain and headaches
This outcome will be measured through daily self-reporting logs that tracks headache, muscle, and joint pain. A numerical rating scale of 0, being no pain, to 10, being worst possible pain, will be used to report pain and headaches.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of sensory and affective aspects of pain
Short Form McGill Pain Questionnaire (SF-MPQ): This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of muscle and joint pain.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of headaches
The Headache Impact Test (HIT-6) will be used to measure how headaches affect the individual's ability to function in different domains. This 6-question form assesses the severity of headache pain and is scored with a range of 36-78, with higher scores indicating a larger impact of headaches on functionality.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of depression
The Hamilton Rating Scale for Depression (HRSD) questionnaire will be used to assess depression, which consists of 21 questions and rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. Only the first 17 items are used for the overall scoring. A score between 14 and 18 represents a moderate form of depression and a score greater than 19 represents severe depression.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of quality of life
The Short Form Health Survey-36 (SF-36) is a self-reported survey of patient health. It is a measure of health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of body pain
A Brief Pain Inventory-Short Form (BPI-SF) questionnaire will also be used to assess the severity of pain and the impact of pain on daily functions. The BPI-SF consists of five questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine". Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes").
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of muscle pain
The New Clinical Fibromyalgia Diagnostic Criteria - Part 1 will be used to assess muscle pain. Patients will be asked to rate the average (over the past 24 hours) intensity of muscle pain for up to 12 locations of the body.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of fibromyalgia
A Revised Fibromyalgia Impact Questionnaire will be used to evaluate the function, overall impact and symptoms of Fibromyalgia. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always."
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of neurobehavioral symptoms
The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of sleep quality
The Pittsburgh Sleep Quality Index (PSQI) questionnaire has nineteen individual items which are used to generate seven composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad."
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of sleep difficulties
The Insomnia Severity Index measures the severity of an individual's sleep difficulties. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of fatigue
The Flinders Fatigue Scale measures daytime fatigue associated with insomnia through a 7-item questionnaire. The questions range from 1-5, with 5 being "extremely" or "entirely."
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Secondary outcomes (3)
Change from baseline to post treatment of PTSD symptoms
The Clinician-Administered PTSD Scale (CAPS-5), 30-item structured interview that can be used to diagnose PTSD and associated symptoms, will be used to assess PTSD symptoms
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Change in opioid-based pain medication usage
Medication assessment consists of daily chronic and breakthrough opioid usage for pain or headache. Average daily dosage will be converted to equal-potent oral Morphine Sulfate dosage based on the clinical opioid conversion table used by the VASDHS Pain Service and University of California, San Diego, Center for Pain Medicine. The study participants will be asked to remain on the same analgesic medication(s) during the study period but are allowed to titrate down their narcotic usage.
Measured: Baseline, 1-week, 1-month, 2-month, and 3-month
Explore changes in supraspinal resting state functional connectivity
The outcome measure will be assessed through functional magnetic imaging scans and subsequent processing.
Measured: Baseline and 1-week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups: one will receive active rTMS and the other group will receive sham rTMS.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Albert Yick Leung, MD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046536
- Sponsor's protocol ID
- SPLD-013-18F
- Other IDs
- H190020
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI
- ClinicalTrials.gov ID
- NCT04046536
- Acronym / sponsor ID
- SPLD-013-18F
- Conditions
- Gulf War Illness, Depression
- Keywords
- rTMS, Transcranial Magnetic Stimulation, Gulf War Illness, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- There will be two groups: one will receive active rTMS and the other group will receive sham rTMS.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS at the LDLPFC | Active comparator | Device: Transcranial Magnetic StimulationSubjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC). |
| Sham rTMS at the LDLPFC | Sham comparator | Device: Sham Transcranial Magnetic StimulationSham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LDLPFC. |
| Active rTMS at the LMC | Experimental | Device: Transcranial Magnetic StimulationSubjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC) |
| Sham rTMS at the LMC | Experimental | Device: Sham Transcranial Magnetic StimulationSham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationA non-invasive treatment that emits magnetic pulses to stimulate the brain. | Device | Active rTMS at the LDLPFC, Active rTMS at the LMC |
| Sham Transcranial Magnetic StimulationSham 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. | Device | Sham rTMS at the LDLPFC, Sham rTMS at the LMC |
Primary outcome
Change from baseline to post treatment of GWI-related pain and headaches
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
This outcome will be measured through daily self-reporting logs that tracks headache, muscle, and joint pain. A numerical rating scale of 0, being no pain, to 10, being worst possible pain, will be used to report pain and headaches.
Change from baseline to post treatment of sensory and affective aspects of pain
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Short Form McGill Pain Questionnaire (SF-MPQ): This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of muscle and joint pain.
Change from baseline to post treatment of headaches
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Headache Impact Test (HIT-6) will be used to measure how headaches affect the individual's ability to function in different domains. This 6-question form assesses the severity of headache pain and is scored with a range of 36-78, with higher scores indicating a larger impact of headaches on functionality.
Change from baseline to post treatment of depression
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Hamilton Rating Scale for Depression (HRSD) questionnaire will be used to assess depression, which consists of 21 questions and rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. Only the first 17 items are used for the overall scoring. A score between 14 and 18 represents a moderate form of depression and a score greater than 19 represents severe depression.
Change from baseline to post treatment of quality of life
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Short Form Health Survey-36 (SF-36) is a self-reported survey of patient health. It is a measure of health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health.
Change from baseline to post treatment of body pain
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
A Brief Pain Inventory-Short Form (BPI-SF) questionnaire will also be used to assess the severity of pain and the impact of pain on daily functions. The BPI-SF consists of five questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine". Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes").
Change from baseline to post treatment of muscle pain
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The New Clinical Fibromyalgia Diagnostic Criteria - Part 1 will be used to assess muscle pain. Patients will be asked to rate the average (over the past 24 hours) intensity of muscle pain for up to 12 locations of the body.
Change from baseline to post treatment of fibromyalgia
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
A Revised Fibromyalgia Impact Questionnaire will be used to evaluate the function, overall impact and symptoms of Fibromyalgia. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always."
Change from baseline to post treatment of neurobehavioral symptoms
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
Change from baseline to post treatment of sleep quality
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Pittsburgh Sleep Quality Index (PSQI) questionnaire has nineteen individual items which are used to generate seven composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad."
Change from baseline to post treatment of sleep difficulties
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Insomnia Severity Index measures the severity of an individual's sleep difficulties. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28.
Change from baseline to post treatment of fatigue
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
The Flinders Fatigue Scale measures daytime fatigue associated with insomnia through a 7-item questionnaire. The questions range from 1-5, with 5 being "extremely" or "entirely."
3 secondary outcomes
Change from baseline to post treatment of PTSD symptoms
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change in opioid-based pain medication usage
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Explore changes in supraspinal resting state functional connectivity
Time frame: Baseline and 1-week post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Yick Leung, MD principal investigator
VA San Diego Healthcare System, San Diego, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Gulf War Illness and Depression, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to post treatment of GWI-related pain and headaches (time frame: Baseline, 1-week, 1-month, 2-month, and 3-month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.