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Behavioural Intervention

Brain Stimulation for Fibromyalgia

N/A

Recruiting

Led By Alexandre Dasilva, DDs,DMedsc

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Fibromyalgia participants must satisfy the American College of Rheumatology (2011) survey criteria for the classification of Fibromyalgia (FM)

Must not have

Healthy control participants must not have routine daily use of opioid analgesics, marijuana or history of substance abuse

Fibromyalgia participants must not have routine daily use of opioid analgesics, marijuana, or history of substance abuse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32)

Summary

This trial is testing a possible treatment for fibromyalgia that involves stimulating certain areas of the brain. The study will compare brain activity and responses to pain in people with and without fibromyalgia, as well as in people with fibromyalgia who receive different types of brain stimulation.

Who is the study for?

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.

What is being tested?

The trial examines how a type of brain activity called explosive synchronization relates to chronic pain in fibromyalgia. It tests whether targeted non-invasive brain stimulation (HD-tDCS) can alter this activity and reduce pain. The study includes assessments using EEG and fMRI neuroimaging before and after sham or actual HD-tDCS treatment.

What are the potential side effects?

Possible side effects from HD-tDCS may include mild discomfort at the electrode sites on the scalp, itching, tingling sensations during treatment, fatigue, headache or nausea post-treatment. Neuroimaging is generally safe but may cause discomfort due to loud noises in MRI or claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average pain level in the past week was 3 or more on a scale of 10.

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I have been diagnosed with Fibromyalgia according to the 2011 criteria.

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I have experienced pain on most days for the last month.

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My pain is almost non-existent based on a recent pain scale.

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I can go to the clinic 5 times a week for HD-tDCS treatments.

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My average pain level over the last week is 3 or more on a scale of 10.

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I can understand and sign the consent form.

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I have had fibromyalgia pain on most days for the last month.

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I barely feel pain, scoring it below 0.5 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not use opioids or marijuana daily and have no history of substance abuse.

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I don't use opioids, marijuana daily, or have a history of substance abuse.

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I have fibromyalgia and have never had a severe head injury.

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I have never had vascular surgery on my legs and do not have current leg vascular problems.

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I have never had a head injury that made me lose consciousness significantly.

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I have fibromyalgia and no history of vascular surgery or issues in my legs.

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I am willing and able to give written consent for a fibromyalgia study.

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I have fibromyalgia without any other autoimmune or inflammatory diseases causing pain.

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I have fibromyalgia and do not suffer from severe mental health issues or recent substance abuse.

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I don't have metal implants or certain dental materials that would interfere with brain scans or electrical stimulation treatments.

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I do not have any long-term illnesses or mental health conditions.

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I do not have nerve damage that affects my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apolipoprotein E

Aim 3 - Change in brain EEG metrics of ES: Change from visit 8 to visit 14 in correlation of EEG alpha band degree and frequency.

Secondary study objectives

Aim 1: Insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy obtained at Visit 2

Aim 1: Resting brain functional connectivity using functional magnetic resonance imaging obtained at Visit 2

Body Weight Changes

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Aim 3- HD-tDCS of ESExperimental Treatment4 Interventions

There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.

Group II: Aim 3 - HD-tDCS of M1Experimental Treatment4 Interventions

There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.

Group III: Aim 1 - Healthy controlExperimental Treatment2 Interventions

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.

Group IV: Aim 1 - Fibromyalgia participantExperimental Treatment2 Interventions

Group V: Aim 3 - ShamPlacebo Group4 Interventions

There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EEG

2013

N/A

~3780

0 / 21Eligibility criteria met