Explosive Synchronization of Brain Network Activity in Chronic Pain

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).

Conditions

• Fibromyalgia
• Healthy Volunteers

Interventions

DIAGNOSTIC_TEST

EEG

EEG with QST (evoked Pain and Visual Stimulation Assessment)

DIAGNOSTIC_TEST

Neuroimaging 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.

DEVICE

HD-tDCS treatments

HD-tDCS treatments (5 active and 5 sham)

DEVICE

Sham HD-tDCS treatments

HD-tDCS treatments (5 active and 5 sham)

DIAGNOSTIC_TEST

Neuroimaging 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Alexandre Dasilva, DDs,DMedsc · University of Michigan

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-13

Primary Completion

2026-07-20

Completion

2026-07-20

FDA Device

Yes

Countries

• United States

Study Locations