Brain Stimulation for Fibromyalgia
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial requires that you do not use stimulant medications or routine daily use of opioid analgesics. You also cannot use over-the-counter pain medications on the day of certain tests or opioid painkillers 48 hours before some scans. Other medications may be allowed, but you should not start any new treatments for fibromyalgia during the study.
What data supports the effectiveness of this treatment for fibromyalgia?
Is brain stimulation for fibromyalgia safe for humans?
How is HD-tDCS treatment different from other treatments for fibromyalgia?
HD-tDCS (High-Definition Transcranial Direct Current Stimulation) is unique because it uses a more focused electrical stimulation to modulate brain activity, specifically targeting the primary motor cortex, which can help reduce pain in fibromyalgia patients. Unlike traditional treatments, it is non-invasive and can provide immediate and lasting pain relief without medication.123910
Research Team
Alexandre Dasilva, DDs,DMedsc
Principal Investigator
University of Michigan
Eligibility Criteria
This trial is for adults with fibromyalgia experiencing pain most days, and healthy right-handed controls with minimal pain. Participants must be able to visit the study site regularly and not start new treatments during the study. Exclusions include severe psychiatric illnesses, certain medical conditions like autoimmune diseases, knowledge of HD-tDCS that could bias results, or safety risks for brain stimulation or imaging.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in Observation
Participants undergo a run-in observational period with EEG, QST, and MRI assessments
Treatment
Participants receive two weeks of HD-tDCS or Sham treatment with 5 daily sessions per week
Follow-up
Participants are monitored for changes in brain connectivity and EEG metrics after treatment
Treatment Details
Interventions
- HD-tDCS treatments
- Sham HD-tDCS treatments
HD-tDCS treatments is already approved in United States, European Union, Canada for the following indications:
- Chronic pain
- Fibromyalgia
- Neuropathic pain
- Chronic pain
- Fibromyalgia
- Neuropathic pain
- Chronic pain
- Fibromyalgia
- Neuropathic pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator