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Could zapping the brain ease fibromyalgia pain?

NCT ID NCT07525063

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Updated 2 times

Summary

This early study tests whether a non-invasive brain stimulation technique called TMS can help reduce pain, fatigue, and brain fog in people with fibromyalgia. About 30 adults will receive multiple TMS sessions and undergo MRI scans to see how the brain changes. The goal is to gather initial data to plan larger future studies on this potential treatment.

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 30 people

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

Started

Jul 2026

Expected to finish

Jun 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 years and older

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.

Inclusions: 1. Female and ages 18 + 2. Ability to read/understand English and give consent to participate 3. Physician diagnosis \& confirmation of primary fibromyalgia syndrome 4. Verbal agreement to maintain dose of prescribed medication (if any) constant throughout the study, except exclusion medication and except if there is a medical emergency requiring changes in medication 5. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study 6. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime) Exclusions: 1. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months) 2. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant) 3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications) 4. male \* TMS-Specific Exclusions: 1\. TMS contraindication (e.g., history of seizures, medications contraindicated for risks/efficacy of TMS procedures) 1. current hypomania, 2. meets diagnostic criteria for current psychotic disorder, or psychotic features, 3. meets diagnostic criteria for Bipolar I disorder, 4. meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity) 5. current uncontrolled anorexia or other condition requiring hospitalization, 6. current serious medical illness, including current severe migraine headaches, 7. changed psychotropic medications in the prior 2 months, or plans to change medication during the study, 8. history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), 9. conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis, 10. use of investigational drug or devices within 4 weeks of screening, 11. cochlear implants, 12. pregnancy * Only females will be enrolled in this study because it focuses on patients who have fibromyalgia which is more prevalent (both diagnosed and self-reported) in females. Due to the contributions of hormones to the conditions under study in this project, female eligibility in this study will be defined as an individual who is female sex at birth and currently female sex

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Conditions

The condition(s) this trial relates to.

Chronic Pain Fatigue fibromyalgia Mental Fatigue Pain Parasomnias

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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Other studies related to the condition(s) this trial covers.