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New hope for fibromyalgia? brain zaps may ease pain and depression

NCT ID NCT07642882

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a non-invasive brain stimulation technique called rTMS can reduce pain and depression in people with fibromyalgia. About 36 adults with chronic pain, some also depressed, will receive either real or sham (fake) rTMS to two brain areas. Researchers will track pain levels for 10 weeks and look for clues to predict who benefits most.

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 36 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

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 80 years

Sex

Anyone

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: * Chronic pain lasting at least 6 months, with or without associated depressive symptoms; * Fibromyalgia (2016 revised ACR criteria and a FIRST questionnaire score of at least 5 out of 6); * Average pain intensity ≥ 4/10 on a 0-10 numeric rating scale; * Pain present daily or almost daily (≥ 4 days per week); * Patients aged over 18 and under 80 years; * Patients who have provided written informed consent; * Patients whose analgesic treatment has been stable for at least 1 month prior to inclusion and will not need to be modified during the study; * Patients who can be followed for the duration of the study (10 weeks); * Patients covered by a health insurance plan or otherwise eligible. Exclusion Criteria: * Ongoing litigation; * Contraindication to rTMS: * Implanted electronic devices and/or conductive objects near the coil: Patients with an active implanted device that is activated or controlled by physiological signals (e.g., pacemakers, implantable cardiac defibrillators \[ICD\], vagus nerve stimulators \[VNS\], wearable cardioverter defibrillators \[WCD\], ocular implants, deep brain stimulation systems, drug infusion pumps or ports, intracardiac leads), even if the device has been removed. * Non-removable metallic objects near the coil:\*\* Patients with a conductive, ferromagnetic, or magnetically sensitive metal implant in the head or within 30 cm of the coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, or bullet fragments); * Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria); * Pregnancy or breastfeeding; * Epilepsy or a history of epilepsy; * Unstable or progressive medical conditions (e.g., cancer); * Psychosis according to DSM-5 criteria; * Presence of another pain condition more severe than the one qualifying for inclusion; * Failure to correctly complete pain self-assessment diaries between inclusion and randomization (fewer than 4 pain scores recorded over 7 days); * Inability to understand the informed consent form, or subjects under legal guardianship or curatorship; * Participation in another research protocol within 30 days prior to inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

  • Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle

    RECRUITING

    Boulogne-Billancourt, Île-de-France Region, 92100, France

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