Explosive Synchronization of Brain Network Activity in Chronic Pain

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT04606095
Status
Recruiting
Apply to this trial

Conditions

  • Fibromyalgia
  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
19 Years - 74 Years
Healthy Volunteers
Accepted

Interventions

  • EEG — DIAGNOSTIC_TEST
    EEG with QST (evoked Pain and Visual Stimulation Assessment)
  • Neuroimaging EEG/fMRI (Aim 1) — DIAGNOSTIC_TEST
    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 — DEVICE
    HD-tDCS treatments (5 active and 5 sham)
  • Sham HD-tDCS treatments — DEVICE
    HD-tDCS treatments (5 active and 5 sham)
  • Neuroimaging EEG/fMRI (Aim 3) — DIAGNOSTIC_TEST
    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.

Study Details

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).

Key Dates

Start date
Nov 13, 2020
Status verified
Mar 2026
Primary completion
Jul 20, 2026
Completion
Jul 20, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aim 1 - Healthy control
    Participants 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.
  • Experimental: Aim 1 - Fibromyalgia participant
    Participants 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.
  • Experimental: Aim 3 - HD-tDCS of M1
    There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.
  • Experimental: Aim 3- HD-tDCS of ES
    There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.
  • Sham Comparator: Aim 3 - Sham
    There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.

Primary Outcome Measure

Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency. [ Time Frame: Visit 1 (day 0) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Alanna Harris
[email protected]
734-998-6839
Alexandre Dasilva, DDs,DMedsc (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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