Explosive Synchronization of Brain Network Activity in Chronic Pain
2 other identifiers
interventional
150
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2026
March 5, 2026
March 1, 2026
5.7 years
October 6, 2020
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
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
Visit 2 (days 0-3)
Aim 1: Insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy obtained at Visit 2
Visit 2 (days 0-3)
Other Outcomes (2)
Aim 3- Change in resting brain functional connectivity using functional magnetic resonance imaging from visit 8 to visit 14.
Visit 8 (approximately day 14- day18), Visit 14 (approximately day 28-32)
Aim 3- Change in insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy from visit 8 to visit 14.
Visit 8 (approximately day 14- day18), Visit 14 (approximately day 28-32)
Study Arms (5)
Aim 1 - Healthy control
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALThere 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
EXPERIMENTALThere 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 COMPARATORThere will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.
Interventions
EEG with QST (evoked Pain and Visual Stimulation Assessment)
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 treatments (5 active and 5 sham)
HD-tDCS treatments (5 active and 5 sham)
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Dasilva, DDs,DMedsc
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The statistician and the study principal investigator will remain blinded as to which data arise from HD-tDCS and Sham, until the study database is locked. The only study personnel that will not be blinded are the staff performing treatment and the project manager, in order to facilitate safety and treatment delivery.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Dentistry
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 28, 2020
Study Start
November 13, 2020
Primary Completion (Estimated)
July 20, 2026
Study Completion (Estimated)
July 20, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share