Actively Recruiting
Explosive Synchronization of Brain Network Activity in Chronic Pain
Led by University of Michigan · Updated on 2026-03-05
150
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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).
CONDITIONS
Official Title
Explosive Synchronization of Brain Network Activity in Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fibromyalgia participants must meet the American College of Rheumatology (2011) criteria for fibromyalgia.
- Fibromyalgia participants must have pain on more than 50% of days in the past month.
- Fibromyalgia participants must have an average pain score of 3 or higher on a 10 cm Visual Analog Scale over the last 7 days.
- Fibromyalgia participants must be willing to limit new medications or treatments for fibromyalgia during the study.
- Participants must be right-handed.
- Participants must be able to travel to the study site for HD-tDCS treatments five times weekly.
- Participants must understand and agree to complete all study procedures.
- Participants must be able to provide written informed consent.
- Healthy control participants must be right-handed.
- Healthy control participants must have pain less than 0.5 cm on a 10 cm Visual Analog Scale over the last 7 days.
- Healthy control participants must understand and agree to complete all study procedures.
- Healthy control participants must be able to provide written informed consent.
You will not qualify if you...
- Fibromyalgia participants with autoimmune or inflammatory diseases causing pain (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease) are excluded.
- History of head injury with significant loss of consciousness.
- Peripheral neuropathy interfering with daily activities.
- Routine daily use of opioid painkillers, marijuana, or history of substance abuse.
- Use of stimulant medications for ADHD/ADD or fatigue related to sleep apnea or shift work.
- Participation in other therapeutic trials.
- Use of as needed over-the-counter pain medications on the day of EEG/MRI.
- Use of as needed opioid painkillers within 48 hours before EEG/MRI.
- Pregnancy or nursing.
- Severe psychiatric illnesses (e.g., schizophrenia, major depression with suicidal thoughts, recent substance abuse).
- Contraindications to EEG, MRI, or HD-tDCS (e.g., metal implants).
- Any condition judged by study staff to prevent completing the study.
- Prior significant experience with tDCS or HD-tDCS treatments.
- History of vascular surgery or vascular dysfunction in lower limbs.
- Involvement in legal or compensation claims related to fibromyalgia.
- Inability or unwillingness to provide written informed consent.
- Healthy controls meeting fibromyalgia criteria or with chronic medical or psychiatric illnesses.
- Active substance disorder in the past 24 months for healthy controls.
- Contraindications for EEG or MRI in healthy controls.
- Use of as needed pain medications on the day of MRI scan in healthy controls.
- Pregnancy or nursing in healthy controls.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Alanna Harris
CONTACT
A
Alexandre Dasilva, DDs,DMedSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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