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Brain zaps for fibromyalgia: small study hopes to find pain relief

NCT ID NCT07260864

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study will test a treatment called rTMS, which uses magnetic pulses to stimulate parts of the brain, in 20 women with fibromyalgia. The goal is to see if stimulating the motor cortex changes brain activity and reduces pain. Researchers will use MRI scans to compare effects on the left and right sides of the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
repetitive transcranial magnetic stimulation (rTMS)
What this could lead to
If it works, this could point toward a non-drug treatment for fibromyalgia pain by showing which side of the brain to stimulate.
What could go wrong
This is a very small, early study with only 20 people, so results may not apply to everyone. It also only looks at brain changes, not long-term pain relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Chronic Pain fibromyalgia Nociplastic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14620, United States

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