Explosive Synchronization of Brain Network Activity in Chronic Pain
Active, not recruitingNot applicableNCT04606095
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Explosive Synchronization of Brain Network Activity in Chronic Pain
- Conditions
- Fibromyalgia
- Healthy Volunteers
- Interventions
- Diagnostic test: EEG
- Diagnostic test: Neuroimaging EEG/fMRI (Aim 1)
- Device: HD-tDCS treatments
- Device: Sham HD-tDCS treatments
- Diagnostic test: Neuroimaging EEG/fMRI (Aim 3)
- Sponsor
- University of Michigan
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2020-11-13
- Primary completion
- 2026-12-20
- Sex
- All
- Age range
- from 19 Years to 74 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04606095