Clinical trial Recruiting at 1 site Interventional Ages 18 to 65 Women only

rTMS for Fibromyalgia: Brain Changes and Side-to-Side Effects

Official title: Investigating the Differential Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Left and Right Motor Cortex in Fibromyalgia: A Prospective Randomized Trial With Functional Magnetic Resonance Imaging (MRI(

Run by University of Rochester · NCT07260864 · Data updated 2026-11-12

This study tests whether repetitive transcranial magnetic stimulation (rTMS) can alter brain activity in people with fibromyalgia and whether brain changes differ when treatment is given to the right vs. left motor cortex.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexWomen only
Enrollment20 (estimated)
SponsorUniversity of Rochester
Academic / other
Locations1 site (Rochester, New York)
StatusRecruiting
StartedDecember 5, 2025
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedAugust 20, 2026
Trial IDNCT07260864 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are right-handed women aged 18–65 with fibromyalgia diagnosed by ACR 2016 criteria, persistent pain ≥4/10, and stable medications.

Probably not a fit

Participants with recent major depressive or anxiety changes, certain psychotic features, or unstable medications may not benefit or may be excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will apply rTMS to the motor cortex of individuals with fibromyalgia to observe changes in brain activity and connectivity. The study uses functional brain imaging to track how the right and left motor areas respond to treatment and whether side-to-side differences exist. Eligible participants are adult women with confirmed fibromyalgia and chronic pain, who meet specific pain and health criteria and are on stable medications. The trial focuses on brain plasticity related to fibromyalgia and may help tailor future rTMS approaches. The study is conducted at the University of Rochester Medical Center with the University of Rochester as the lead sponsor.

Why it matters

Potential benefit: If successful, rTMS could offer a non-drug approach to modulate brain activity and potentially reduce pain in fibromyalgia.

How similar studies have gone: Previous brain-imaging studies suggest rTMS can modulate pain-related brain networks, but results vary and this side-to-side comparison is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion 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 Inventory), except in cases with psychotic or manic features.
* 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 kept at a steady dosage during the trial.
* 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 participate.

Exclusion Criteria:

* Inability to provide informed consent.
* Age outside the studied range (i.e., \< 18, \> 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 they shade areas other than typical fibromyalgia pain, we will discuss any previous diagnosis, the intensity and chronicity of pain, and exclude them if chronic pain in any area outside the condition in to be studied is confirmed.
* 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 psychosis, or anxiety disorders are not exclusion criteria).
* 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 mellitus, stable hypertension (meaning that these conditions are followed up on by a physician and they are getting treatment for it with clinical stability), or hyperlipidemia are not exclusion criteria.
* 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 ink, and claustrophobia.
* 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.

Where it's running

  • University of Rochester Medical Center
    Rochester, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.