Explosive Synchronization of Brain Network Activity in Chronic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fibromyalgia
- Healthy Volunteers
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study can run Aims 1 and 3 and the same time. Females that have FM can participate in Aim 3.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The statistician and the study principal investigator will remain blinded as to which data arise from HD-tDCS and Sham, until the study database is locked. The only study personnel that will not be blinded are the staff performing treatment and the project manager, in order to facilitate safety and treatment delivery.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 74 years
- Gender
- Both males and females
Description
In the first part healthy controls (25 female/10 males) and fibromyalgia (25 female/10 males) participants that are enrolled in this phase will have 3 visits as well as a run-in observational period (up to a total of 33 days). During this time, participants will complete surveys, as well as have ele...
In the first part healthy controls (25 female/10 males) and fibromyalgia (25 female/10 males) participants that are enrolled in this phase will have 3 visits as well as a run-in observational period (up to a total of 33 days). During this time, participants will complete surveys, as well as have electroencephalograms (EEG) with quantitative sensory testing and functional Magnetic resonance imaging (fMRI). Hypothesis: FM patients will display greater ES in the brain, compared to pain-free controls when assessed with EEG at rest. Furthermore, patients experiencing increased clinical pain, will display increases in ES metrics In the third part FM patients will be enrolled (50) and receive treatment with either sham treatment followed by M1 HD-tDCS or sham treatment followed by ES HD-tDCS. These participants will also complete surveys and have neuroimaging EEG/MRI. Hypothesis: Following a course of HD-tDCS targeted at either A.) the motor cortex (M1) or B.) an ES-sensitive region identified in Aim 2, FM patients will display decreased strength of ES conditions (correlation between node degree and frequency) as compared to Sham, when assessed with EEG. Moreover, the degree of pain reduction following HD-tDCS will correlate with the amount of reduction in these network parameters leading to ES. If unable to identify an ES-sensitive region using computer modeling in Aim 2, our hypothesis for motor cortex stimulation is that HD-tDCS at M1 will result in decreased ES conditions as compared to Sham, when assessed with EEG.
Tracking Information
- NCT #
- NCT04606095
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Principal Investigator: Richard Harris, MD University of Michigan
Get Well Soon