Brain Stimulation for Fibromyalgia

Overseen By Alexandre Dasilva, DDs,DMedSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Opioids, Marijuana, Stimulants, others

Disqualifiers: Autoimmune diseases, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 2 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether non-invasive brain stimulation can help with fibromyalgia, a condition causing widespread pain and fatigue. Researchers are testing high-definition transcranial direct current stimulation (HD-tDCS) to determine if it can reduce pain and improve brain function. Participants will receive either this brain stimulation or a "sham" (fake) treatment for comparison. The trial seeks individuals who have experienced fibromyalgia pain most days over the past month and are willing to attend sessions five times a week. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for fibromyalgia.

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 prior data suggests that this brain stimulation technique is safe for fibromyalgia patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people. Studies have found that it can help relieve pain and reduce symptoms in those with fibromyalgia. Participants in past studies did not report any major safety concerns.

tDCS is non-invasive, meaning it doesn't involve surgery or entering the body. It uses small electrical currents to stimulate specific areas of the brain. This method has been tested for various conditions, including fibromyalgia, and is often well-tolerated.

Some studies report that people may experience mild side effects, such as skin tingling or headaches, but these usually resolve quickly. Overall, the evidence suggests that tDCS is a safe option for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HD-tDCS (high-definition transcranial direct current stimulation) treatments for fibromyalgia because they offer a unique mechanism of action compared to standard treatments like pain relievers, antidepressants, and physical therapy. Unlike these conventional options, HD-tDCS is a non-invasive brain stimulation technique that targets specific brain regions thought to be involved in pain processing. This targeted approach could potentially modulate pain perception more effectively and with fewer side effects. Additionally, the potential for rapid treatment sessions over a short period offers an innovative approach to managing fibromyalgia symptoms.

What evidence suggests that HD-tDCS treatments might be an effective treatment for fibromyalgia?

Research has shown that high-definition transcranial direct current stimulation (HD-tDCS), which participants in this trial may receive, can help reduce pain in people with fibromyalgia. One study found that participants who received real tDCS treatment reported less pain compared to those who received a placebo. Another study found that some patients experienced up to a 50% reduction in their fibromyalgia pain. Additionally, tDCS may improve movement skills, especially in complex tasks, for women with fibromyalgia. These findings suggest that HD-tDCS could effectively manage fibromyalgia symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Alexandre Dasilva, DDs,DMedsc

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

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

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

Healthy control participants must be capable of giving written informed consent

Exclusion Criteria

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

I will not take OTC pain meds on the day of my EEG/MRI.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in Observation

Participants undergo a run-in observational period with EEG, QST, and MRI assessments

Up to 33 days

3 visits (in-person)

Treatment

Participants receive two weeks of HD-tDCS or Sham treatment with 5 daily sessions per week

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in brain connectivity and EEG metrics after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HD-tDCS treatments
• Sham HD-tDCS treatments

Trial Overview 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.

How Is the Trial Designed?

Group I: Aim 3- HD-tDCS of ES Experimental Treatment 4 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 M1 Experimental Treatment 4 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 control Experimental Treatment 2 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 participant Experimental Treatment 2 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 V: Aim 3 - Sham Placebo Group 4 Interventions

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

HD-tDCS treatments is already approved in United States, European Union, Canada for the following indications:

Approved in United States as HD-tDCS for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Approved in European Union as HD-tDCS for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Approved in Canada as HD-tDCS for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a randomized clinical trial involving 35 women with fibromyalgia, ten sessions of active transcranial direct current stimulation (tDCS) significantly reduced pain levels immediately after treatment and maintained these improvements for up to 90 days.

The active tDCS group also experienced enhancements in quality of life and reductions in fatigue, indicating that this non-invasive treatment could be a beneficial option for managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Anodal Transcranial Direct Current Stimulation on the Primary Motor Cortex in Women With Fibromyalgia: A Randomized, Triple-Blind Clinical Trial. Loreti, EH., Freire, AM., Alexandre da Silva, A., et al.[2023]

Transcranial direct current stimulation (tDCS) significantly reduced pain levels in 46 Korean patients with fibromyalgia, showing improvements in visual analogue scale (VAS) pain scores after treatment, indicating its potential as an effective add-on therapy.

The treatment was safe, with no serious adverse events reported, and it also led to improvements in fatigue and depression scores, although it did not significantly affect anxiety or sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of add-on transcranial direct current stimulation on pain in Korean patients with fibromyalgia. Kang, JH., Choi, SE., Park, DJ., et al.[2021]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Anodal transcranial direct current stimulation (tDCS) applied to the primary motor cortex significantly improved pain and overall function in patients with fibromyalgia, based on a meta-analysis of six randomized controlled trials involving 192 participants.

No significant adverse effects were reported, indicating that this treatment is safe, although it did not improve the pressure pain threshold compared to sham stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effiectiveness and safety of transcranial direct current stimulation in fibromyalgia: A systematic review and meta-analysis. Zhu, CE., Yu, B., Zhang, W., et al.[2022]

Transcranial direct current stimulation (tDCS) targeting the primary motor cortex significantly reduced pain in fibromyalgia patients compared to sham stimulation, with effects lasting for at least 3 weeks after treatment.

The treatment was generally safe, with only mild adverse events reported, and cognitive function remained stable across all treatment groups, suggesting that tDCS could be a promising noninvasive option for managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Fregni, F., Gimenes, R., Valle, AC., et al.[2022]

In a randomized controlled trial with 23 fibromyalgia patients, daily sessions of anodal transcranial direct current stimulation (tDCS) combined with multidisciplinary rehabilitation led to a significant reduction in pain perception as measured by the SF-36 pain domain.

While patients tolerated the tDCS treatment well without adverse effects, the overall improvements in quality of life and other pain measures were not statistically significant, suggesting that while tDCS may help with pain, its effectiveness in broader treatment contexts remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transcranial direct current stimulation coupled with a multidisciplinary rehabilitation program for the treatment of fibromyalgia. Riberto, M., Marcon Alfieri, F., Monteiro de Benedetto Pacheco, K., et al.[2022]

In a study involving 18 fibromyalgia patients, both anodal and cathodal high-definition transcranial direct current stimulation (HD-tDCS) significantly reduced perceived pain compared to sham stimulation, showing immediate effects after cathodal stimulation and lasting effects for both types 30 minutes post-treatment.

The HD-tDCS technique was well tolerated by patients and also resulted in increased mechanical detection thresholds, indicating potential benefits beyond pain reduction, suggesting its usefulness in both research and clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal modulation of the primary motor cortex in fibromyalgia using 4×1-ring high-definition transcranial direct current stimulation (HD-tDCS): immediate and delayed analgesic effects of cathodal and anodal stimulation. Villamar, MF., Wivatvongvana, P., Patumanond, J., et al.[2022]

In a study involving 38 fibromyalgia patients, high-definition transcranial alternating current stimulation (HD-tACS) showed a significant reduction in the fibromyalgia impact questionnaire (FIQ) scores after two weeks, indicating potential benefits in managing symptoms.

Despite the positive findings, there were no significant differences in pain intensity compared to sham stimulation, and while most side effects were mild, one serious adverse event (a suicide attempt) raises safety concerns that need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study. Lin, AP., Chiu, CC., Chen, SC., et al.[2023]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

Home-based active transcranial direct current stimulation (a-tDCS) significantly reduced pain scores in patients with fibromyalgia, with a 36.53% reduction for the left dorsolateral prefrontal cortex (l-DLPFC) and 45.89% for the primary motor cortex (M1) compared to sham stimulation.

a-tDCS over M1 not only improved pain scores but also enhanced the function of the descending pain inhibitory system and increased the heat pain threshold, indicating its potential as an effective therapeutic approach for managing fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Home-Based Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex in the Disability Due to Pain in Fibromyalgia: A Factorial Sham-Randomized Clinical Study. Caumo, W., Lopes Ramos, R., Vicuña Serrano, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10813480/

Efficacy of Transcranial Direct Current Stimulation on Pain ... A small, significant improvement in pain was observed under the active tDCS but not the sham condition. Fibromyalgia-related daily functioning ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590015008846

Clinically Effective Treatment of Fibromyalgia Pain With ... We present an optimized protocol option for the treatment of fibromyalgia (FM) pain. We report a clinically significant benefit of a 50% pain reduction in ...

3. epain.org epain.org/journal/view.html?uid=1917&vmd=Full

Effects of Transcranial Direct Current Stimulation on pain ... Conclusions: Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord ...

4. jpain.org jpain.org/article/S1526-5900(23)00529-1/fulltext

A Factorial Sham-Randomized Clinical Study Home-based transcranial direct current stimulation (HB-tDCS) improved pain and disability. •. Home-based transcranial direct current stimulation ...

5. mdpi.com mdpi.com/2076-3425/14/9/928

Effectiveness of Transcranial Direct Current Stimulation ... tDCS during VR tasks significantly improved motor performance in women with FM, particularly in complex, extensive movements.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0987705324000029

Efficacy and safety of transcranial direct current stimulation ... tDCS is a safe intervention that relieves pain intensity, reduces depression, and reduces the impact of FM on life.

7. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/10346

Effiectiveness and safety of transcranial direct current ... Transcranial direct current stimulation of 3 cortical targets is no more effective than placebo as treatment for fibromyalgia: a double-blind ...

8. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-023-03445-7

The effects of transcranial direct-current stimulation (tDCS) on ... tDCS is a non-invasive brain stimulation technique that has shown promise as a potential treatment for FM by modulating pain perception and reducing symptoms.