Gulf War SyndromeNCT04182659
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
A study testing Transcranial Magnetic Stimulation in people with Gulf War Syndrome and Gulf War Illness, run by Veterans Medical Research Foundation at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gulf War Syndrome, Gulf War Illness, Headache
- 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
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2019to 30 Sep 2023
- 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
- 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
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, 3 recruiting
- Recruiting
VA Atlanta
Decatur, Georgia, 30033
Carly Ragin, BS, 404-321-6111 ext. 206566, Carly.Ragin@va.gov
Anna Woodbury, MD
- Recruiting
VA Palo Alto
Palo Alto, California, 94304
Valentino Basilio, 650-514-6614, Vbasilio@pavir.org
Maheen Adamson, PhD
- Recruiting
VA San Diego Healthcare System
San Diego, California, 92161
Caleb Lopez, BS, 858-552-8585 ext. 2638, caleb.lopez@va.gov
Albert Y Leung, MD
About this study
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.
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). 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.
- Conditions
- Gulf War Syndrome, Gulf War Illness, Headache, Muscle Pain, Joint Pain
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- rTMS, Transcranial Magnetic Stimulation, Gulf War Illness
- Medical subject headings
- Persian Gulf Syndrome, Headache, Myalgia, Arthralgia
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 LMC | Active comparator | 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 | 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 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 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
Baseline, 1-week, 1-month, 2-month, and 3-month
Measured: 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
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 VA San Diego Healthcare System 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 posted2 Dec 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- 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 are 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Albert Leung, M.D., Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182659
- Sponsor's protocol ID
- H190071
- Status last verified
- Aug 2023
- First submitted
- 27 Nov 2019
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
- ClinicalTrials.gov ID
- NCT04182659
- Acronym / sponsor ID
- H190071
- Conditions
- Gulf War Syndrome, Gulf War Illness, Headache, Muscle Pain, Joint Pain
- Keywords
- rTMS, Transcranial Magnetic Stimulation, Gulf War Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Dec 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 long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.
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). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- There are two groups: one will receive active rTMS and the other group will receive sham rTMS.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS at the LMC | Active comparator | 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 | 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 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
- 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
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 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 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 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: 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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- 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 Leung, M.D. principal investigator
San Diego Veterans Healthcare System
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 Syndrome and Gulf War Illness, run by Veterans Medical Research Foundation 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caleb Lopez, BS (858-552-8585 ext. 2638, caleb.lopez@va.gov), or a site near the patient. 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 11 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 9 Aug 2023.