Chronic PainPhase 3rTMSNCT01608321
rTMS for the Treatment of Chronic Pain in GW1 Veterans
A Phase 3 study testing rTMS in people with Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study was designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the first Gulf War (GW1) who often suffer from chronic pain problems. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Born between 1936 and 1973 (ages 18 to 55 during Gulf War I) and were deployed to the Persian Gulf during Gulf War I.
- Patients must have symptoms suggestive of Gulf War Illness, including
- Chronic pain >= 4 on the pain severity scale of the BPI-SF at screening
- At least 2 other symptoms in at least one of the other five (5) categories defined by the 2013 IOM report (Gulf War and Health, Treatment for Chronic Multisymptom Illness): fatigue, mood and cognition, gastrointestinal, respiratory, and neurological
- Ability to obtain a Motor Threshold (MT) will be determined at the end of the screening process.
- If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
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- Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
- For female participants, agrees to use one of the following acceptable methods of birth control:
- Complete abstinence (not having sexual intercourse with anyone)
- An oral contraceptive (birth control pills)
- Norplant
- Depo-Provera
- A condom with spermicide
- A cervical cap with spermicide
- A diaphragm with spermicide
- An Intrauterine device
- Surgical sterilization (having your tubes tied)
- Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments.
Who cannot join
- Pregnant or lactating female (This is a Federal Drug Administration (FDA)-required exclusion. In the future, if rTMS becomes a proven treatment for pain, its safety in the context of pregnancy should be studied separately (Nahas et al 1999)).
- Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increases the risk of having seizures.
- Have a cardiac pacemaker.
- Have an implanted device (deep brain stimulation) or metal in the brain.
- Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
- Known current psychosis as determined by Diagnostic and Statistical Manual (DSM-IV) coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
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- Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake interview)
- Current amnesic disorders, dementia, Mini Mental Status Exam (MMSE) 24 or delirium.
- Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by medical history, within 3 months prior to screening.
- History of loss of consciousness greater than 15 minutes due to head injury.
- Participation in another concurrent clinical trial.
- Patients with prior exposure to rTMS.
- Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
This study was designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the first Gulf War (GW1) who often suffer from chronic pain problems.
Read the detailed description
A number of studies have been conducted on the health of Veterans deployed to Iraq during GW1. The focus of these studies has been primarily to define the nature of symptoms and symptom clusters and to determine if evidence supports the definition of a new unique illness. Most noteworthy is the "Iowa Study", a cross-sectional study of 3,695 Veterans from Iowa consisting of those who were and were not deployed in GW1. In telephone interviews the Gulf War deployed Veterans reported approximately twice the number of symptoms compared to those who were not deployed.
The often ambiguous and seemingly treatment resistant symptoms presented by GW1 Veterans represent a challenge to the Veteran's Affairs Health Care System on two fronts; efficacy in treatment and cost. In particular, unlike most medical conditions which can be diagnosed by objective medical findings, pain is a subjective experience (International Association for the Study of Pain, 1994). Therefore the investigators propose to engage in a clinical trial of rTMS in chronic pain that occurs in the context of multiple medical symptoms in the GW1 population. The symptom category approach will be applied with the restriction that enrolled GWI diagnosed patients will have symptoms of chronic pain as outlined in the musculoskeletal category and at least two additional symptoms.
- Conditions
- Chronic Pain
- Being tested
- rTMS, Sham device
- Keywords
- Chronic Pain, Gulf War Illness, Gulf War Syndrome, Fibromyalgia, repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, Veterans
- Medical subject headings
- Chronic Pain, Persian Gulf Syndrome, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Repetitive Transcranial Magnetic Stimulation
Sham deviceDevice
Placebo Device that simulates active rTMS treatment
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel. Receives: Device: rTMS |
| Sham rTMS | Placebo comparator | Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Brief Pain Inventory (Short Form) Score
The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.
Measured: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionSep 2015
Why it stopped: Did not meet recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind study of rTMS versus sham
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John W Ashford, MD PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608321
- Sponsor's protocol ID
- SPLD-001-11F
- Acronym
- rTMS
- Status last verified
- Apr 2017
- First submitted
- 25 May 2012
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Trial discontinued before an adequate number of subjects was tested.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS for the Treatment of Chronic Pain in GW1 Veterans
- ClinicalTrials.gov ID
- NCT01608321
- Acronym / sponsor ID
- rTMS / SPLD-001-11F
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Gulf War Illness, Gulf War Syndrome, Fibromyalgia, repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, Veterans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet recruitment goals
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the first Gulf War (GW1) who often suffer from chronic pain problems.
Detailed description
A number of studies have been conducted on the health of Veterans deployed to Iraq during GW1. The focus of these studies has been primarily to define the nature of symptoms and symptom clusters and to determine if evidence supports the definition of a new unique illness. Most noteworthy is the "Iowa Study", a cross-sectional study of 3,695 Veterans from Iowa consisting of those who were and were not deployed in GW1. In telephone interviews the Gulf War deployed Veterans reported approximately twice the number of symptoms compared to those who were not deployed.
The often ambiguous and seemingly treatment resistant symptoms presented by GW1 Veterans represent a challenge to the Veteran's Affairs Health Care System on two fronts; efficacy in treatment and cost. In particular, unlike most medical conditions which can be diagnosed by objective medical findings, pain is a subjective experience (International Association for the Study of Pain, 1994). Therefore the investigators propose to engage in a clinical trial of rTMS in chronic pain that occurs in the context of multiple medical symptoms in the GW1 population. The symptom category approach will be applied with the restriction that enrolled GWI diagnosed patients will have symptoms of chronic pain as outlined in the musculoskeletal category and at least two additional symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind study of rTMS versus sham
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: rTMSThose receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel. |
| Sham rTMS | Placebo comparator | Device: Sham deviceThose receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Born between 1936 and 1973 (ages 18 to 55 during Gulf War I) and were deployed to the Persian Gulf during Gulf War I.
- Patients must have symptoms suggestive of Gulf War Illness, including
- Ability to obtain a Motor Threshold (MT) will be determined at the end of the screening process.
- If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
- Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
Key exclusion criteria (13 listed)
- Pregnant or lactating female (This is a Federal Drug Administration (FDA)-required exclusion. In the future, if rTMS becomes a proven treatment for pain, its safety in the context of pregnancy should be studied separately (Nahas et al 1999)).
- Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increases the risk of having seizures.
- Have a cardiac pacemaker.
- Have an implanted device (deep brain stimulation) or metal in the brain.
- Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
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 |
|---|---|---|
| rTMSRepetitive Transcranial Magnetic Stimulation | Device | rTMS |
| Sham devicePlacebo Device that simulates active rTMS treatment | Device | Sham rTMS |
Primary outcome
Change in the Brief Pain Inventory (Short Form) Score
Time frame: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)
The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Trial discontinued before an adequate number of subjects was tested.
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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.
John W Ashford, MD PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rTMS in people with Chronic Pain, run by VA Office of Research and Development at 1 site 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 18 inclusion and 13 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: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in the Brief Pain Inventory (Short Form) Score (time frame: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)). 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 11 Apr 2017.