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Recruiting NCT04606095

Explosive Synchronization of Brain Network Activity in Chronic Pain

Trial Parameters

Condition Fibromyalgia
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 19 Years
Max Age 74 Years
Start Date 2020-11-13
Completion 2026-07-20
Interventions
EEGNeuroimaging EEG/fMRI (Aim 1)HD-tDCS treatments

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).

Eligibility Criteria

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 Exclus

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