Gulf War SyndromeNCT03030794
Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS
A study testing Repetitive transcranial magnetic stimulation in people with Gulf War Syndrome and Headache, run by Veterans Medical Research Foundation at 2 sites in United States.
Trial summary
This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gulf War Syndrome, Headache
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
- Male or female between ages 18-65
- Served at least 30 consecutive days in the Persian Gulf between 8/90-7/91
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 32Show 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
- Criteria for healthy veterans without Gulf War Illness headaches and pain:
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Naval Medical Center San Diego
San Diego, California, 92134
Veteran Affairs Hospital
San Diego, California, 92161
About this study
This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain.
Read the detailed 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.
- Conditions
- Gulf War Syndrome, Headache
- Being tested
- Repetitive transcranial magnetic stimulation, Repetitive transcranial magnetic stimulation (sham)
- Keywords
- Gulf War Illness, Headache, Muscle Pain, Joint Pain, TMS
- 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.
Repetitive transcranial magnetic stimulationDevice
A non-invasive method of brain stimulation that emits a magnetic pulse.
Repetitive transcranial magnetic stimulation (sham)Device
No brain stimulation will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive TMS | Active comparator | Subjects will receive the repetitive transcranial magnetic stimulation study procedure. Receives: Device: Repetitive transcranial magnetic stimulation |
| No (blocked) repetitive TMS | Placebo comparator | 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. Receives: Device: Repetitive transcranial magnetic stimulation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Headache and Pain Log
This is a daily self-reporting log that tracks headache, muscle pain, and joint pain levels. The pain levels are scored from 0-10 with 10 being the worst possible pain.
Measured: 2 months for each subject (11 visits)
Headache Impact Test 6 (HIT-6)
This 6-question form assesses the severity of headache pain and is scored with a range of 36-78. The higher score, the higher the impact of headaches on functional ability.
Measured: 2 months for each subject (11 visits)
2 months for each subject (11 visits)
This assessment has 9 questions about pain level, relief, and interference. Pain level and interference questions range from 0-10, with 10 being the worst. Level of relief has a range of 0-100%, with 100% being complete relief.
Measured: 2 months for each subject (11 visits)
Opioid Medication Assessment
This is a self-reporting log that tracks opioid medication usage. Average daily dosages are converted to equal-potent oral Morphine Sulfate dosage and reported in milligrams.
Measured: 2 months for each subject (11 visits)
Mechanical-Visual Analogue Scale
This scale measures the level of headache, muscle, and joint pain at each visit. This ranges from 0-100, with 100 being the worst possible pain.
Measured: 2 months for each subject (11 visits)
Secondary outcomes (13)
Neurobehavioral Symptom Inventory (NSI)
This is a 22-question self-report assessment that tracks symptoms over time. Each question ranges from 0-4, with 4 being very severe. The total NSI score ranges from 0-88.
Measured: 2 months for each subject (11 visits)
Short-Form McGill Pain Questionnaire (SF-MPQ)
This self-reporting survey contains 15 questions that describe the type of pain. Each descriptor is scored between 0-3, with 3 being severe pain. The total score then ranges from 0-45. This questionnaire is filled out one each for joint pain and one for muscle pain.
Measured: 2 months for each subject (11 visits)
New Clinical Fibromyalgia Diagnostic Criteria
This form contains a checklist of 19 possible areas for muscle pain. The checkmarks are tallied to give the Widespread Pain Index score, which ranges from 0-19. A score of 19 would suggest muscle pain in all 19 possible locations.
Measured: 2 months for each subject (11 visits)
Revised Fibromyalgia Impact Questionnaire (FIQR)
This 3-part questionnaire measures the level of interference the pain causes, the overall impact of the pain, and intensity of the symptoms. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always." The FIQR total has a range of 0-210.
Measured: 2 months for each subject (11 visits)
Conners Continuous Performance Test 2 (CPT2)
This is a 15-minute attention task administered on a laptop. The subject is prompted to press the spacebar as quickly as possible after every letter that appears on the screen except for the letter X. The exam is automatically scored by the program and reports omission rate and response latency. The attentional cognitive function is tracked by their change in these scores over time.
Measured: 2 months for each subject (11 visits)
Hopkins Verbal Learning Test (HVLT)
This is a memory and recall task that requires the subject to memorize a list of 10 words and recall them. There are 3 trials and they are scored just by the number of words that can be recalled each time, which can be from 0-10 for a total range of 0-30 words. The second part of this test rates their recognition discrimination index by asking if certain words were on the original list. This is scored by taking the number of true positives and subtracting the false positives. The range for this is from 0-12, with 12 indicative of better discrimination within memory.
Measured: 2 months for each subject (11 visits)
Trailmaking Test A&B
This is a timed test that is administered to assess executive function. Both tests have a series of numbers or numbers and letters that are to be connected in sequential order. The faster the completion time, the better the executive function.
Measured: 2 months for each subject (11 visits)
This is a timed test that is administered to assess executive function. Both tests have a series of numbers or numbers and letters that are to be connected in sequential order. The faster the completion time, the better the executive function.
This is an administered IQ test that is designed to measure intelligence and cognitive ability in adults and older adolescents. There are several parts to the test, with each response being scored from 0-2 or 0-4 based on the quality of the answer or the completion time. The raw scores are then converted to scaled scores and summed to give the Full Scale score. The higher the Full Scale score, the higher the IQ classification.
Measured: 2 months for each subject (11 visits)
Hamilton Rating Scale for Depression
This questionnaire rates the severity of depression in 21 questions. Each question either ranges from 0-2 or 0-4. The sum of the scores would give the total score, where a higher score would mean more severe depression.
Measured: 2 months for each subject (11 visits)
36-Item Short Form Survey Instrument (SF-36)
This is a 38-question survey that assesses physical function, physical health limitations, emotional problem limitations, fatigue, emotional well-being, social functioning, pain, and general health. The scoring follows the official guidelines by RAND, where certain questions determine each health aspect. The questions are rated from 1-5, and then scored from 0-100. Each health aspect will have a range of 0-100, with 100 suggesting a more favorable health state.
Measured: 2 months for each subject (11 visits)
Sleep Quality Assessment (PSQI)
This is self-reporting survey has 9 questions and determines the quality and patterns of sleep. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad." The responses will be scored based on the guidelines at the bottom of the page. The global PSQI score then has a range of 0-21, with 21 indicative of poor sleep quality.
Measured: 2 months for each subject (11 visits)
Insomnia Severity Index
This survey has 7 questions that rate the severity of insomnia problems. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28, with 28 being severe clinical insomnia.
Measured: 2 months for each subject (11 visits)
Flinders Fatigue Scale
This questionnaire contains 7 questions in order to determine the level of fatigue one is experiencing. The questions range from 1-5, with 5 being "extremely" or "entirely." The higher one scores, the more severe the fatigue.
Measured: 2 months for each subject (11 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
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, VA San Diego Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030794
- Sponsor's protocol ID
- H160047
- Status last verified
- Aug 2018
- First submitted
- 4 Jan 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leung A, Donohue M, Xu R, Lee R, Lefaucheur JP, Khedr EM, Saitoh Y, Andre-Obadia N, Rollnik J, Wallace M, Chen R. rTMS for suppressing neuropathic pain: a meta-analysis. J Pain. 2009 Dec;10(12):1205-16. doi: 10.1016/j.jpain.2009.03.010. Epub 2009 May 23.
PubMed 19464959Leung A, Shukla S, Fallah A, Song D, Lin L, Golshan S, Tsai A, Jak A, Polston G, Lee R. Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2016 Feb;19(2):133-41. doi: 10.1111/ner.12364. Epub 2015 Nov 10.
PubMed 26555886Lei K, Kunnel A, Metzger-Smith V, Golshan S, Javors J, Wei J, Lee R, Vaninetti M, Rutledge T, Leung A. Diminished corticomotor excitability in Gulf War Illness related chronic pain symptoms; evidence from TMS study. Sci Rep. 2020 Oct 28;10(1):18520. doi: 10.1038/s41598-020-75006-8.
PubMed 33116195
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS
- ClinicalTrials.gov ID
- NCT03030794
- Acronym / sponsor ID
- H160047
- Conditions
- Gulf War Syndrome, Headache
- Keywords
- Gulf War Illness, Headache, Muscle Pain, Joint Pain, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Dec 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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 assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive TMS | Active comparator | Device: Repetitive transcranial magnetic stimulationSubjects will receive the repetitive transcranial magnetic stimulation study procedure. |
| No (blocked) repetitive TMS | Placebo comparator | Device: Repetitive transcranial magnetic stimulation (sham)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (32 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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationA non-invasive method of brain stimulation that emits a magnetic pulse. | Device | Repetitive TMS |
| Repetitive transcranial magnetic stimulation (sham)No brain stimulation will be administered. | Device | No (blocked) repetitive TMS |
Primary outcome
Daily Headache and Pain Log
Time frame: 2 months for each subject (11 visits)
This is a daily self-reporting log that tracks headache, muscle pain, and joint pain levels. The pain levels are scored from 0-10 with 10 being the worst possible pain.
Headache Impact Test 6 (HIT-6)
Time frame: 2 months for each subject (11 visits)
This 6-question form assesses the severity of headache pain and is scored with a range of 36-78. The higher score, the higher the impact of headaches on functional ability.
2 months for each subject (11 visits)
Time frame: 2 months for each subject (11 visits)
This assessment has 9 questions about pain level, relief, and interference. Pain level and interference questions range from 0-10, with 10 being the worst. Level of relief has a range of 0-100%, with 100% being complete relief.
Opioid Medication Assessment
Time frame: 2 months for each subject (11 visits)
This is a self-reporting log that tracks opioid medication usage. Average daily dosages are converted to equal-potent oral Morphine Sulfate dosage and reported in milligrams.
Mechanical-Visual Analogue Scale
Time frame: 2 months for each subject (11 visits)
This scale measures the level of headache, muscle, and joint pain at each visit. This ranges from 0-100, with 100 being the worst possible pain.
13 secondary outcomes
Neurobehavioral Symptom Inventory (NSI)
Time frame: 2 months for each subject (11 visits)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 2 months for each subject (11 visits)
New Clinical Fibromyalgia Diagnostic Criteria
Time frame: 2 months for each subject (11 visits)
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: 2 months for each subject (11 visits)
Conners Continuous Performance Test 2 (CPT2)
Time frame: 2 months for each subject (11 visits)
Hopkins Verbal Learning Test (HVLT)
Time frame: 2 months for each subject (11 visits)
Trailmaking Test A&B
Time frame: 2 months for each subject (11 visits)
This is a timed test that is administered to assess executive function. Both tests have a series of numbers or numbers and letters that are to be connected in sequential order. The faster the completion time, the better the executive function.
Time frame: 2 months for each subject (11 visits)
Hamilton Rating Scale for Depression
Time frame: 2 months for each subject (11 visits)
36-Item Short Form Survey Instrument (SF-36)
Time frame: 2 months for each subject (11 visits)
Sleep Quality Assessment (PSQI)
Time frame: 2 months for each subject (11 visits)
Insomnia Severity Index
Time frame: 2 months for each subject (11 visits)
Flinders Fatigue Scale
Time frame: 2 months for each subject (11 visits)
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 Jan 2020.
- Background: PubMed 19464959Leung A, Donohue M, Xu R, Lee R, Lefaucheur JP, Khedr EM, Saitoh Y, Andre-Obadia N, Rollnik J, Wallace M, Chen R. rTMS for suppressing neuropathic pain: a meta-analysis. J Pain. 2009 Dec;10(12):1205-16. doi: 10.1016/j.jpain.2009.03.010. Epub 2009 May 23.
- Background: PubMed 26555886Leung A, Shukla S, Fallah A, Song D, Lin L, Golshan S, Tsai A, Jak A, Polston G, Lee R. Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2016 Feb;19(2):133-41. doi: 10.1111/ner.12364. Epub 2015 Nov 10.
- Derived from this study: PubMed 33116195Lei K, Kunnel A, Metzger-Smith V, Golshan S, Javors J, Wei J, Lee R, Vaninetti M, Rutledge T, Leung A. Diminished corticomotor excitability in Gulf War Illness related chronic pain symptoms; evidence from TMS study. Sci Rep. 2020 Oct 28;10(1):18520. doi: 10.1038/s41598-020-75006-8.
- 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
VA San Diego Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Gulf War Syndrome and Headache, run by Veterans Medical Research Foundation at 2 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 10 inclusion and 32 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Daily Headache and Pain Log (time frame: 2 months for each subject (11 visits)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030794, which also lists 3 linked publications.
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 Jan 2020.