tDCS + Exercise for Fibromyalgia

No longer recruiting at 1 trial location

Overseen By Felipe Fregni, MD PhD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Opiates

Disqualifiers: Unstable medical, Psychiatric, Pregnancy, others

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

Compensation: Varies

Number of Visits: 16

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial direct current stimulation (tDCS), combined with exercise, can help manage pain in people with fibromyalgia. The researchers are testing various combinations of real and sham treatments to determine the most effective approach. This trial may suit individuals who have experienced fibromyalgia pain for over six months without relief from common pain medications. Participants must also be able to feel light touch on their forearm. As an unphased trial, this study provides a unique opportunity to investigate innovative pain management techniques for fibromyalgia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have pain resistant to common pain medications like Tylenol, Aspirin, and Ibuprofen.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with fibromyalgia. Studies have found that this treatment can reduce pain and improve daily life without major side effects. In one study, fibromyalgia patients who received active tDCS experienced significantly less pain compared to those who received a fake (inactive) treatment.

Another study found that tDCS can lower pain levels, reduce depression, and ease daily activities affected by fibromyalgia. These results suggest that tDCS is well-tolerated, with no major safety concerns reported in these studies.

Overall, while tDCS appears promising for managing fibromyalgia symptoms, research so far indicates it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tDCS combined with exercise for fibromyalgia because it offers a fresh approach by targeting the brain's electrical activity to potentially reduce pain and improve function. Unlike typical fibromyalgia treatments, which often involve medications like antidepressants and pain relievers, tDCS (transcranial Direct Current Stimulation) uses gentle electrical currents to modulate brain activity, possibly leading to fewer side effects. The trial also explores the combination of active and sham exercises, aiming to understand how physical activity intensity impacts the treatment's effectiveness. This innovative combination of brain stimulation and exercise could open new paths for managing fibromyalgia symptoms more effectively.

What evidence suggests that this trial's treatments could be effective for fibromyalgia?

Research has shown that transcranial direct current stimulation (tDCS) can reduce pain in people with fibromyalgia. In several studies, patients who received real tDCS reported a noticeable drop in pain levels compared to those who received a fake (inactive) version. One analysis found that tDCS not only reduced pain but also helped with depression and the overall effects of fibromyalgia. In this trial, participants will be assigned to different treatment arms, including combinations of active or sham tDCS and active or sham exercise. Combining tDCS with exercise proved more effective than using tDCS or exercise alone. These findings suggest that tDCS might be a promising option for managing fibromyalgia pain. ^{1 2 3 4 5}

Who Is on the Research Team?

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

Adults aged 18-65 with fibromyalgia, experiencing pain for over 6 months and resistant to common painkillers. Participants must be able to feel touch on their forearm and provide informed consent. Excluded are those with unstable medical/psychiatric disorders, substance abuse history, significant neurological issues or surgeries, high opiate use, severe depression, or pregnancy.

Inclusion Criteria

You need to be able to feel the touch of a special fiber on your forearm.

I have been diagnosed with fibromyalgia pain, lasting more than 6 months and averaging at least a 4 on the pain scale, with no other chronic pain conditions.

My pain doesn't improve with common painkillers like Tylenol or Ibuprofen.

Exclusion Criteria

You are pregnant or could become pregnant.

You have used drugs or alcohol excessively in the past 6 months. If you say you have, we will check using specific criteria.

I am currently taking high doses of pain medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 16 sessions of tDCS combined with exercise over 4 weeks

4 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview

The trial is testing the combination of transcranial direct current stimulation (tDCS) and exercise on pain control in fibromyalgia patients. It will compare active tDCS with sham (placebo) tDCS and active exercise with sham exercise over four weeks to see which methods best engage the body's natural pain regulation.

How Is the Trial Designed?

Group I: Active tDCS and Active Exercise Experimental Treatment 2 Interventions

Active tDCS for 20 min Active exercise (60-70% max HR) for 30 min

Group II: Sham tDCS and Active Exercise Active Control 2 Interventions

Sham tDCS for 20 min Active exercise (60-70% max HR) for 30 min

Group III: Active tDCS and Sham Exercise Active Control 2 Interventions

Active tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min

Group IV: Sham TDCS and Sham Exercise Placebo Group 2 Interventions

Sham tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Published Research Related to This Trial

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]

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]

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]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10621179/

The effects of transcranial direct-current stimulation (tDCS) on ...

The analysis showed that active tDCS significantly reduced pain intensity in FM patients in comparison to the sham group.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0987705324000029

Efficacy and safety of transcranial direct current stimulation ...

This meta-analysis of twenty studies found that tDCS can reduce pain, relieve depression, and reduce the impact of FM. The certainty of the evidence was ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2835058

Home-Based Transcranial Direct Current Stimulation vs ...

In this randomized clinical trial involving 112 women with fibromyalgia, A-tDCS combined with exercise and PNE significantly outperformed sham tDCS with ...

5.

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 ...