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Could a headset replace pills for fibromyalgia pain?

NCT ID NCT07203339

Symptom relief Sponsor: Hospital de Clinicas de Porto Alegre Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares a home-use brain stimulation device (tDCS) to the drug duloxetine for treating fibromyalgia in 610 women. Participants use the device daily for 4 weeks or take duloxetine, both combined with exercise and pain education. The goal is to see if tDCS works as well as the drug, with fewer side effects.

What this could mean

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

Active substance
transcranial direct current stimulation (tDCS) device and duloxetine
What this could lead to
If it works, this could offer fibromyalgia patients a safe, home-based alternative to medication, reducing side effects and improving quality of life.
What could go wrong
This is a non-inferiority trial, so tDCS may prove no better than duloxetine. The treatment is self-administered at home, which could affect consistency. Results may not apply to men or other populations.

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 610 people

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

Started

Sep 2025

Expected to finish

Dec 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 75 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.

Eligibility Criteria Inclusion Criteria: * Woman aged between 18 and 75 years * Right-handed * Literate in reading and writing * Clinical diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) 2010-2016 criteria * Numeric Pain Scale (NPS) score ≥ 4 on most days in the past 30 days * Agree no changes in medication dosage during the treatment period (except for analgesics) * Able to swallow tablets * Able to understand instructions for using tDCS at home Exclusion Criteria: * Living more than 250 km from Porto Alegre * Pregnancy * Decompensated systemic diseases * Chronic inflammatory rheumatologic diseases * Untreated hypothyroidism * Active cancer under treatment * Alcohol or drug abuse in the past 6 months * Decompensated psychiatric disorders with suicide risk and a defined plan * Use of duloxetine at a dose \> 60 mg/day * Metal implants in the brain * Implanted brain medical devices * Cardiac pacemaker * Cochlear implant * Neurological disorders * History of traumatic brain injury or neurosurgery

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

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

BDNF Duloxetine EEG Fibromyalgia (FM) TDCS

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

  • Hospital de Clínicas de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, Brazil

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