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Investigating rTMS for Fibromyalgia

This study is looking at how a treatment called repetitive transcranial magnetic stimulation (rTMS) affects the brains of people with fibromyalgia. rTMS uses magnetic fields to stimulate nerve cells in the brain. Researchers want to see if rTMS changes brain activity in the areas that control movement, and if these changes are different depending on which side of the brain receives the treatment. The study is open to women aged 18 to 65 who have been diagnosed with fibromyalgia for at least three months. The main goal is to measure changes in brain activity after 10 rTMS sessions over two weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive 10 sessions of rTMS over two weeks. Brain activity will be measured at the beginning and after the treatment.
Compensation
Not stated in the trial record.
Follow-up
Brain activity will be measured at baseline and immediately after 10 sessions of rTMS over two weeks.

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NCT07260864

Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia

Recruiting
NAAges 18–65Interventional
University of Rochester
~20 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:rTMS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change in Primary Motor Cortex (M1) Connectopy Profile
Measured over Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).

Conditions

Fibromyalgia (FM)

Explore related trials

Fibromyalgia

Where it's being run

1 sites across 1 states
New York1

Who to contact

Olivia Caraccio, BS/BA
[email protected]
5853136322
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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%.
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.
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.

What this trial measures

  • Mean Change in Primary Motor Cortex (M1) Connectopy ProfileBaseline and post-treatment (after 10 sessions of rTMS over 2 weeks).

    Resting-state fMRI will be used to derive connectopy embeddings of the primary motor cortex (M1). Connectopy embeddings from the stimulated side will be extracted from significant baseline-defined clusters. A single value per participant is derived by averaging the embedding values within this cluster. Higher scores indicate increased similarity to healthy reference profiles (improved functional connectivity), while lower scores indicate deviation from healthy reference patterns (reduced functional connectivity).