FibromyalgiaNCT04606095
Explosive Synchronization of Brain Network Activity in Chronic Pain
A study testing EEG, Neuroimaging EEG/fMRI (Aim 1) and HD-tDCS treatments in people with Fibromyalgia and Healthy Volunteers, run by University of Michigan at 1 site in United States.
Trial summary
This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. Read more about this study
- Who is it for?
- Ages 19 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Healthy Volunteers
- What is being tested?
- EEG, Neuroimaging EEG/fMRI (Aim 1) and HD-tDCS treatments
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).
Read the detailed description
In the first part healthy controls (25 female/10 males) and fibromyalgia (25 female/10 males) participants that are enrolled in this phase will have 3 visits as well as a run-in observational period (up to a total of 33 days). During this time, participants will complete surveys, as well as have electroencephalograms (EEG) with quantitative sensory testing and functional Magnetic resonance imaging (fMRI).
Hypothesis: FM patients will display greater ES in the brain, compared to pain-free controls when assessed with EEG at rest. Furthermore, patients experiencing increased clinical pain, will display increases in ES metrics
In the third part FM patients will be enrolled (50) and receive treatment with either sham treatment followed by M1 HD-tDCS or sham treatment followed by ES HD-tDCS. These participants will also complete surveys and have neuroimaging EEG/MRI.
Hypothesis: Following a course of HD-tDCS targeted at either A.) the motor cortex (M1) or B.) an ES-sensitive region identified in Aim 2, FM patients will display decreased strength of ES conditions (correlation between node degree and frequency) as compared to Sham, when assessed with EEG. Moreover, the degree of pain reduction following HD-tDCS will correlate with the amount of reduction in these network parameters leading to ES. If unable to identify an ES-sensitive region using computer modeling in Aim 2, our hypothesis for motor cortex stimulation is that HD-tDCS at M1 will result in decreased ES conditions as compared to Sham, when assessed with EEG.
After consultation with and approval by NIH from September through November 2024, and IRB approval in January 2025, the testing involved for outcome measures 5 and 6 was removed for future participants, thus effectively demoting those outcome measures to exploratory.
- Conditions
- Fibromyalgia, Healthy Volunteers
- Being tested
- EEG, Neuroimaging EEG/fMRI (Aim 1), HD-tDCS treatments, Sham HD-tDCS treatments, Neuroimaging EEG/fMRI (Aim 3)
- Keywords
- Explosive synchronization
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
EEG with QST (evoked Pain and Visual Stimulation Assessment)
Neuroimaging EEG/fMRI (Aim 1)Diagnostic test
This will be done to monitor areas of the brain that are involved in thinking and processing pain. The scanner stimulates the brain to send out signals that will be recorded and analyzed. Additionally, during the MRI the participants brain's electrical activity with will be measured with an EEG machine for part of the MRI. About halfway through the scan, participants will have the EEG equipment removed and then will return to the fMRI scanner for a few additional scans.
HD-tDCS treatmentsDevice
HD-tDCS treatments (5 active and 5 sham)
Sham HD-tDCS treatmentsDevice
HD-tDCS treatments (5 active and 5 sham)
Neuroimaging EEG/fMRI (Aim 3)Diagnostic test
This will be done to monitor areas of the brain that are involved in thinking and processing pain. The scanner stimulates the brain to send out signals that will be recorded and analyzed. Additionally, during the MRI the participants brain's electrical activity with will be measured with an EEG machine for part of the MRI. About halfway through the scan, participants will have the EEG equipment removed and then (for participants prior to January 2025) will return to the fMRI scanner for a few additional scans.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 - Healthy control | Experimental | Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures. Receives: Diagnostic Test: EEG; Diagnostic Test: Neuroimaging EEG/fMRI (Aim 1) |
| Aim 1 - Fibromyalgia participant | Experimental | Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures. Receives: Diagnostic Test: EEG; Diagnostic Test: Neuroimaging EEG/fMRI (Aim 1) |
| Aim 3 - HD-tDCS of M1 | Experimental | There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week. Receives: Diagnostic Test: EEG; Device: HD-tDCS treatments; Device: Sham HD-tDCS treatments; Diagnostic Test: Neuroimaging EEG/fMRI (Aim 3) |
| Aim 3- HD-tDCS of ES | Experimental | There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week. Receives: Diagnostic Test: EEG; Device: HD-tDCS treatments; Device: Sham HD-tDCS treatments; Diagnostic Test: Neuroimaging EEG/fMRI (Aim 3) |
| Aim 3 - Sham | Sham comparator | There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week. Receives: Diagnostic Test: EEG; Device: HD-tDCS treatments; Device: Sham HD-tDCS treatments; Diagnostic Test: Neuroimaging EEG/fMRI (Aim 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency.
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).
Measured: Visit 1 (day 0)
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.
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.
Measured: Visit 8 (approximately day 14- day18), Visit 14 (approximately day 28-32)
Secondary outcomes (2)
Aim 1: Resting brain functional connectivity using functional magnetic resonance imaging obtained at Visit 2
Resting brain functional connectivity Z statistic will be assessed with functional magnetic resonance imaging (fMRI). The resting brain connectivity to the insula and Default Mode Network structures will be assessed with both seed based and independent component based fMRI analysis.
Measured: Visit 2 (days 0-3)
Aim 1: Insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy obtained at Visit 2
The concentration of Glx (glutamate + glutamine) within the insular brain region, will be assessed with proton magnetic resonance spectroscopy (H-MRS). Analysis will be done with linear combination model software (LCModel).
Measured: Visit 2 (days 0-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start13 Nov 2020
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study can run Aims 1 and 3 and the same time. Females that have FM can participate in Aim 3.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Alexandre DaSilva, DDS, DMedSc, University of Michigan
- Investigators
- Alexandre Dasilva, DDs,DMedsc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606095
- Sponsor's protocol ID
- HUM00180975
- Other IDs
- 1R01AT010060-01A1
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2020
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explosive Synchronization of Brain Network Activity in Chronic Pain
- ClinicalTrials.gov ID
- NCT04606095
- Acronym / sponsor ID
- HUM00180975
- Conditions
- Fibromyalgia, Healthy Volunteers
- Keywords
- Explosive synchronization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).
Detailed description
In the first part healthy controls (25 female/10 males) and fibromyalgia (25 female/10 males) participants that are enrolled in this phase will have 3 visits as well as a run-in observational period (up to a total of 33 days). During this time, participants will complete surveys, as well as have electroencephalograms (EEG) with quantitative sensory testing and functional Magnetic resonance imaging (fMRI).
Hypothesis: FM patients will display greater ES in the brain, compared to pain-free controls when assessed with EEG at rest. Furthermore, patients experiencing increased clinical pain, will display increases in ES metrics
In the third part FM patients will be enrolled (50) and receive treatment with either sham treatment followed by M1 HD-tDCS or sham treatment followed by ES HD-tDCS. These participants will also complete surveys and have neuroimaging EEG/MRI.
Hypothesis: Following a course of HD-tDCS targeted at either A.) the motor cortex (M1) or B.) an ES-sensitive region identified in Aim 2, FM patients will display decreased strength of ES conditions (correlation between node degree and frequency) as compared to Sham, when assessed with EEG. Moreover, the degree of pain reduction following HD-tDCS will correlate with the amount of reduction in these network parameters leading to ES. If unable to identify an ES-sensitive region using computer modeling in Aim 2, our hypothesis for motor cortex stimulation is that HD-tDCS at M1 will result in decreased ES conditions as compared to Sham, when assessed with EEG.
After consultation with and approval by NIH from September through November 2024, and IRB approval in January 2025, the testing involved for outcome measures 5 and 6 was removed for future participants, thus effectively demoting those outcome measures to exploratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- This study can run Aims 1 and 3 and the same time. Females that have FM can participate in Aim 3.
| Arm | Type | Receives |
|---|---|---|
| Aim 1 - Healthy control | Experimental | Diagnostic Test: EEG, Diagnostic Test: Neuroimaging EEG/fMRI (Aim 1)Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures. |
| Aim 1 - Fibromyalgia participant | Experimental | Diagnostic Test: EEG, Diagnostic Test: Neuroimaging EEG/fMRI (Aim 1)Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures. |
| Aim 3 - HD-tDCS of M1 | Experimental | Diagnostic Test: EEG, Device: HD-tDCS treatments, Device: Sham HD-tDCS treatments, Diagnostic Test: Neuroimaging EEG/fMRI (Aim 3)There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week. |
| Aim 3- HD-tDCS of ES | Experimental | Diagnostic Test: EEG, Device: HD-tDCS treatments, Device: Sham HD-tDCS treatments, Diagnostic Test: Neuroimaging EEG/fMRI (Aim 3)There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week. |
| Aim 3 - Sham | Sham comparator | Diagnostic Test: EEG, Device: HD-tDCS treatments, Device: Sham HD-tDCS treatments, Diagnostic Test: Neuroimaging EEG/fMRI (Aim 3)There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGEEG with QST (evoked Pain and Visual Stimulation Assessment) | Diagnostic test | Aim 1 - Fibromyalgia participant, Aim 1 - Healthy control, Aim 3 - HD-tDCS of M1, Aim 3 - Sham, Aim 3- HD-tDCS of ES |
| Neuroimaging EEG/fMRI (Aim 1)This will be done to monitor areas of the brain that are involved in thinking and processing pain. The scanner stimulates the brain to send out signals that will be recorded and analyzed. Additionally, during the MRI the participants brain's electrical activity with will be measured with an EEG machine for part of the MRI. About halfway through the scan, participants will have the EEG equipment removed and then will return to the fMRI scanner for a few additional scans. | Diagnostic test | Aim 1 - Fibromyalgia participant, Aim 1 - Healthy control |
| HD-tDCS treatmentsHD-tDCS treatments (5 active and 5 sham) | Device | Aim 3 - HD-tDCS of M1, Aim 3 - Sham, Aim 3- HD-tDCS of ES |
| Sham HD-tDCS treatmentsHD-tDCS treatments (5 active and 5 sham) | Device | Aim 3 - HD-tDCS of M1, Aim 3 - Sham, Aim 3- HD-tDCS of ES |
| Neuroimaging EEG/fMRI (Aim 3)This will be done to monitor areas of the brain that are involved in thinking and processing pain. The scanner stimulates the brain to send out signals that will be recorded and analyzed. Additionally, during the MRI the participants brain's electrical activity with will be measured with an EEG machine for part of the MRI. About halfway through the scan, participants will have the EEG equipment removed and then (for participants prior to January 2025) will return to the fMRI scanner for a few additional scans. | Diagnostic test | Aim 3 - HD-tDCS of M1, Aim 3 - Sham, Aim 3- HD-tDCS of ES |
Primary outcome
Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency.
Time frame: 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.
Time frame: 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.
2 secondary outcomes
Aim 1: Resting brain functional connectivity using functional magnetic resonance imaging obtained at Visit 2
Time frame: Visit 2 (days 0-3)
Aim 1: Insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy obtained at Visit 2
Time frame: Visit 2 (days 0-3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Dasilva, DDs,DMedsc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG, Neuroimaging EEG/fMRI (Aim 1) and HD-tDCS treatments in people with Fibromyalgia and Healthy Volunteers, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency. (time frame: Visit 1 (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.