Could a Head-Zap device ease fibromyalgia pain at home?
NCT ID NCT07583056
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
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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
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Locations
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Hospital Clínico Universitario de Valencia
RECRUITINGValencia, Spain
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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- Brain zaps might quiet fibromyalgia pain without drugs