Could a Head-Zap device ease fibromyalgia pain at home?

NCT ID NCT07583056

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 2 times

Summary

This study tests whether a high-dose version of a gentle brain-stimulation device (tDCS) can reduce pain and other symptoms in 250 people with fibromyalgia. Participants will use the device at home, either on the motor cortex or the prefrontal cortex, and researchers will compare results to a standard protocol. The goal is to find a convenient, non-drug option for symptom relief.

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
What this could lead to
If successful, this could offer a safe, non-drug way to manage fibromyalgia pain and fatigue at home, reducing reliance on medications.
What could go wrong
This is an early-stage trial testing a new high-dose schedule. The benefits may be small or no better than standard tDCS, and not everyone may respond.

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 250 people

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

Started

Jul 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

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: * Patients who meet the diagnostic criteria described by the American College of Rheumatology (Wolfe et al., 2016): * Widespread Pain Index (WPI) ≥7 and Symptom Severity Scale (SSS) score ≥5 or a WPI score of 4-6 and SSS ≥9 * Presence of widespread pain, defined as pain in at least 4 of 5 regions. Jaw, chest, and abdominal pain are not included in the definition of widespread pain. * Symptoms have been generally present for at least 3 months. * The diagnosis of fibromyalgia (FM) is valid regardless of other diagnoses. The diagnosis of FM does not exclude the presence of other clinically significant diseases. * Patients with a stable prescription (or lack thereof) for antidepressant/pharmacological medication and who agree to continue it throughout the study. * Demonstrate the ability to properly administer home-based tDCS independently or with the assistance of a caregiver. * Have access to an electronic device with a camera (mobile phone or computer) to allow for monitoring of the intervention and communication with the participant. * Have the capacity and willingness to commit to the study team for the completion of all phases of the study. * Volunteer to participate and sign the specific informed consent form for this study. Exclusion Criteria: * Presenting with immune system disorders or comorbidities that explain the main symptoms of fibromyalgia: rheumatoid arthritis, lupus, autoimmune, neurological, and oncological disorders. * Presenting with any uncompensated clinical condition such as ischemic heart disease, kidney disease, or liver disease. * Presenting with dermatological conditions, such as allergic skin reactions at the electrode sites, psoriasis, etc. * Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): * Metallic implants or head injuries, any electronic device such as cochlear implants or cardiac pacemakers. * Brain stimulation within the last 6 months. * A clinical or family history of epilepsy. * Having any structural lesion (for example, any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that could affect safety, participation in the study, or confound the interpretation of the study results, as determined by the investigator. * History of drug or alcohol abuse during the study or in the 3 months prior (except for nicotine). * Changes in drug treatment in the month prior to starting the trial. * Awaiting trial or litigation during the trial. * Pregnancy

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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

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. A doctor treating you

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Contacts and locations

Locations

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, Spain

    Contact Email: •••••@•••••

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