RecruitingNot ApplicableNCT04606095

Explosive Synchronization of Brain Network Activity in Chronic Pain

Sponsor

University of Michigan

Enrollment

150 participants

Start Date

Nov 13, 2020

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Fibromyalgia

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

Min Age: 19 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying EEG, a medical device called HD-tDCS treatments, and others for people with fibromyalgia and healthy volunteers. The study is currently recruiting participants at 1 location. People eligible for this study include aged 19 Years to 74 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTEEG

EEG with QST (evoked Pain and Visual Stimulation Assessment)

DIAGNOSTIC_TESTNeuroimaging 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.

DEVICEHD-tDCS treatments

HD-tDCS treatments (5 active and 5 sham)

DEVICESham HD-tDCS treatments

HD-tDCS treatments (5 active and 5 sham)

DIAGNOSTIC_TESTNeuroimaging 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.