Explosive Synchronization of Brain Network Activity in Chronic Pain

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 74
Healthy Volunteers: t
View:

• 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

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Alanna Harris
alannah@med.umich.edu
734-998-6839
Backup
Alexandre Dasilva, DDs,DMedSc
adasilva@umich.edu
734-763-5280
Time Frame
Start Date: 2020-11-13
Estimated Completion Date: 2026-02-20
Participants
Target number of participants: 150
Treatments
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.
Authors
Richard Harris
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov