Brain zaps may unlock fibromyalgia pain secrets
NCT ID NCT04606095
First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 4 times
Summary
This study looks at how brain networks synchronize in people with fibromyalgia, a condition causing widespread pain. Researchers will use EEG and fMRI to measure brain activity and test a gentle brain stimulation technique called HD-tDCS. The goal is to understand pain processing and see if stimulation can reduce symptoms. 150 adults with fibromyalgia and healthy volunteers will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-definition transcranial direct current stimulation (HD-tDCS)
- What this could lead to
- If successful, this could point toward a new non-invasive brain stimulation treatment for fibromyalgia pain.
- What could go wrong
- This is an early-stage study focused on understanding brain activity, not a treatment trial. The stimulation approach may not reduce pain in all patients.
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 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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 For Fibromyalgia Participants: * Satisfy the American College of Rheumatology (2011) survey criteria for the classification of Fibromyalgia (FM). * Continued presence of pain for more than 50% of days for the past month. * Mean recalled pain over the last seven days (7-day recall) greater than or equal to 3 on a 10 centimeter (cm) Visual Analog Scale (VAS) for pain; 7-day recall * Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study. * Right-handed. * Able to travel to the study site to receive (HD-tDCS) treatments five times weekly * Understanding and willing to complete all study procedures. * Capable of giving written informed consent. Inclusion Criteria for Healthy Control Participants: * Right-handed * Pain less than 0.5cm on a 10cm Visual Analog Scale (VAS) for pain; 7-day recall * Understanding and willing to complete all study procedures * Capable of giving written informed consent Exclusion Criteria for Fibromyalgia Participants: * Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, et cetera (etc.) that causes pain. * History of head injury with substantial loss of consciousness * Peripheral neuropathy of known cause that interferes with activities of daily living. * Routine daily use of opioid analgesics, marijuana, or history of substance abuse. * Stimulant medications, such as those used to treat attention-deficit/hyperactivity disorder (ADHD)/Attention deficit disorder (ADD) (for example (e.g.), amphetamine/ dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded. * Concurrent participation in other therapeutic trials. * Use of as needed (PRN) over the counter (OTC) pain medications (Nonsteroidal anti-inflammatory drugs (NSAIDs), etc.) on day of electroencephalogram (EEG)/Magnetic resonance imaging (MRI). * Use of PRN opioid analgesics 48 hours prior to EEG/MRI scan. * Pregnant or nursing. A pregnancy test will be given prior to EEG/MRI sessions. * Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years) * Contraindications to EEG/MRI or HD-tDCS methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material. * Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigators that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator. * Sufficient knowledge of HD-tDCS techniques to prevent "blinding" of the patient to the study interventions (including significant previous tDCS or HD-tDCS treatment) * Presence of factors that may preclude the safe use of HD-tDCS * History vascular surgery in lower limbs or current lower limb vascular dysfunction. * Subjects with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the subject's fibromyalgia; or currently receiving monetary compensation as a result of any of the above. * Inability or unwillingness of individual to give written informed consent. Exclusion Criteria for Healthy Control Participants: * Have met the American College of Rheumatology (2011) survey criteria for the classification of FM. * Have any chronic medical illness including psychiatric disorders (psychosis, schizophrenia, delusional disorder, etc). (self-reported) * History of head injury with substantial loss of consciousness * Peripheral neuropathy of known cause that interferes with activities of daily living * Routine daily use of opioid analgesics, marijuana or history of substance abuse * Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded. * Concurrent participation in other therapeutic trials. * Pregnant or nursing. A pregnancy test will be given prior to EEG/MRI sessions. * Contraindications for EEG or MRI. * Use of PRN over the counter (OTC) pain medications (NSAIDs, etc.) on day of MRI scan. * Use of PRN opioid analgesics 48 hours prior to MRI scan. * Active substance disorder in the past 24 months, as determined by subject self-report. * History vascular surgery in lower limbs or current lower limb vascular dysfunction. * Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigators that would prevent satisfactory completion of the study protocol. * Inability or unwillingness of individual to give written informed consent.
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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.
Contacts and locations
Locations
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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