Clinical trial for Fibromyalgia (FM)
Official title Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia
ClinicalTrials.gov ID: NCT07260864
What this study is testing
- What it's testing
- The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS (repetitive transcranial magnetic stimulation). Researchers are looking at how the parts of the brain that control movement (called motor cortices) respond to this treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Female aged 18 to 65, right-handed, with no racial/ethnic restrictions.
- A diagnosis of fibromyalgia by a qualified physician according to the American College of Rheumatology 2016 criteria
- Must have a history of fibromyalgia pain for a duration ≥ 3 months, as it is included in the diagnostic criteria.
- Must have pain intensity equal or greater than 4/10 on the numerical rating scale (NRS) at enrollment.
- Concurrent chronic overlapping pain conditions (except migraine with aura), depression, and anxiety will be allowed when mild to moderate (Less than...
You likely can't join if
- Inability to provide informed consent.
- Age outside the studied range (i.e., \ 65).
- Patients planning to change their medications during trial.
- Participants who are currently receiving other alternative therapies during trial (e.g., physiotherapy, acupuncture).
- History of receiving TMS, transcranial direct current stimulation (tDCS), or electroconvulsive therapy (ECT).
- Evidence of rheumatologic disorders, autoimmune diseases, taking immunosuppressive treatment, severe or unstable cardiac diseases.
See the full eligibility criteria
- Female aged 18 to 65, right-handed, with no racial/ethnic restrictions.
- A diagnosis of fibromyalgia by a qualified physician according to the American College of Rheumatology 2016 criteria
- Must have a history of fibromyalgia pain for a duration ≥ 3 months, as it is included in the diagnostic criteria.
- Must have pain intensity equal or greater than 4/10 on the numerical rating scale (NRS) at enrollment.
- Concurrent chronic overlapping pain conditions (except migraine with aura), depression, and anxiety will be allowed when mild to moderate (Less than 31 on Beck Depression Inventory or less than 36 on Beck Anxiety...
- Concomitant medication (except tricyclics, antipsychotic medications, bupropion, methadone, theophylline) and their doses for mood, pain and sleep disorders must be steady at least 4 weeks before enrolment and must be...
- Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires.
- Must be in generally stable health.
- Must sign an informed consent document after explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to...
- Inability to provide informed consent.
- Age outside the studied range (i.e., \ 65).
- Patients planning to change their medications during trial.
- Participants who are currently receiving other alternative therapies during trial (e.g., physiotherapy, acupuncture).
- History of receiving TMS, transcranial direct current stimulation (tDCS), or electroconvulsive therapy (ECT).
- Evidence of rheumatologic disorders, autoimmune diseases, taking immunosuppressive treatment, severe or unstable cardiac diseases.
- Fibromyalgia must be the primary complaint; hence patients cannot have another main source of pain (e.g., osteoarthritis). Patients will be asked to shade all the areas in which they experience pain on a body map. If...
- Involvement in litigation regarding their pain or having a disability claim or receiving workman compensation or seeking either because of their pain.
- Any history of hemorrhagic or thrombotic stroke.
- History of schizophrenia, schizoaffective disorder, bipolar disorders, mania, hypomania, eating disorders, or any psychiatric illness with psychotic features (major depressive disorder, mild to moderate without...
- Current use of tricyclic antidepressants or any antipsychotic medications, given the risk of seizure incidence independent of TMS use in tricyclics is up to 0.4% or second-generation antipsychotics up to 1.2%.
- Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, sleep apnea, or malignancy. Stable diabetes...
- History of traumatic brain injury
- History of epileptic disorders or family history of seizures in first degree relatives
- History of syncope
- History of tinnitus or hearing loss
- Current or history of substance misuse/dependence including alcohol at time of entry into the study.
- History of COVID-19 infection with persistent neurologic symptoms.
- Intra-axial implants (e.g., spinal cord stimulators or pumps) that are MRI incompatible.
- All exclusion criteria for MRI and TMS safety: any metallic implants, chips, or plates, cochlear implants, brain or skull abnormalities, aneurysm clips or coils, non-removable piercings, tattoos containing ferromagnetic...
- Surgery within the past 3 months or history of any brain surgery
- Pregnancy
- Participation into another research study
- In the judgment of the investigator, unable or unwilling to follow the protocol and instructions.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.