Brain Activity and Chronic Pain Study for Fibromyalgia
This study is looking at how brain activity, specifically something called 'explosive synchronization' (ES), is involved in chronic pain for people with fibromyalgia. Researchers want to see if a type of non-invasive brain stimulation called HD-tDCS (high-definition transcranial direct current stimulation) can help treat this. You could be eligible if you are between 19 and 74 years old and have fibromyalgia with ongoing pain. The study will measure your brain activity using EEG (electroencephalogram) and fMRI (functional magnetic resonance imaging) before and after receiving either active HD-tDCS or a sham (inactive) version. The goal is to see if changes in brain activity after HD-tDCS are linked to a reduction in pain.
- Study design
- This interventional study plans to enroll 150 participants, including people with fibromyalgia and healthy volunteers. It involves different groups, with some receiving active HD-tDCS and others receiving sham HD-tDCS.
- What's involved
- Participants will have multiple visits, including surveys, EEG with quantitative sensory testing, and fMRI scans. Some participants will also undergo one week of HD-tDCS treatments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in brain activity will be measured at visits approximately 14-18 days and 28-32 days after the start of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04606095
Explosive Synchronization of Brain Network Activity in Chronic Pain
Active, Not Recruiting
NAAges 19–74InterventionalTreatmentUniversity of MichiganInvestigator-initiated
~150 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:EEGNeuroimaging EEG/fMRI (Aim 1)HD-tDCS treatmentsSham HD-tDCS treatmentsNeuroimaging EEG/fMRI (Aim 3)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency.
Measured over Visit 1 (day 0)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMichigan1
Study leadership
- Alexandre Dasilva, DDs,DMedsc · PRINCIPAL_INVESTIGATOR · University of Michigan
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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
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.
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.
What this trial measures
- Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency.Visit 1 (day 0)
Correlation between EEG alpha band degree and frequency will be calculated as the primary outcome measure. Brain related EEG data will be analyzed using computer software designed for EEG data as well as Statistical Package for the Social Sciences (SPSS).
- Aim 3 - Change in brain EEG metrics of ES: Change from visit 8 to visit 14 in correlation of EEG alpha band degree and frequency.Visit 8 (approximately day 14- day18), Visit 14 (approximately day 28-32)
Change of correlation between EEG alpha band degree and frequency from visit 8 to visit 14 is the primary outcome. Brain related EEG data will be analyzed using computer software designed for EEG data as well as SPSS.