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NCT04606095 · University of Michigan

Explosive Synchronization of Brain Network Activity in Chronic Pain

What this study is about

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.

View original scientific description

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).

Interventions

DIAGNOSTIC_TEST

EEG

EEG with QST (evoked Pain and Visual Stimulation Assessment)

DIAGNOSTIC_TEST

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.

DEVICE

HD-tDCS treatments

HD-tDCS treatments (5 active and 5 sham)

DEVICE

Sham HD-tDCS treatments

HD-tDCS treatments (5 active and 5 sham)

DIAGNOSTIC_TEST

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.

Primary outcome measures

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.

Where

  • Ann Arbor, Michigan

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Related conditions & keywords

FibromyalgiaHealthy VolunteersExplosive synchronization

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations

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1 of 150 participants interested
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Study locations

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RECRUITING

Ann Arbor

Michigan

Location available

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Join others in Michigan exploring innovative treatment options through clinical research

Fibromyalgia Treatment Options in Ann Arbor, Michigan

If you're searching for Fibromyalgia treatment in Ann Arbor, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Ann Arbor and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Fibromyalgia. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Michigan
Now Enrolling
Up to 150 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Fibromyalgia?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Fibromyalgia

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Fibromyalgia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04606095. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.