tDCS + Exercise for Fibromyalgia

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

116 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)\] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial \[tDCS (active and sham) and aerobic exercise (AE) (active and control)\] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.

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.

What data supports the effectiveness of the treatment tDCS for fibromyalgia?

Research shows that transcranial direct current stimulation (tDCS) can lead to small but significant improvements in pain and daily functioning for people with fibromyalgia, with no serious side effects. Combining tDCS with exercise may enhance these benefits, improving pain, functional performance, and quality of life. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for people with fibromyalgia?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for people with fibromyalgia, with no serious side effects reported. Patients tolerated the treatment well, and there was no significant difference in adverse effects between those receiving real and sham (fake) tDCS. ^{1 2 3 6 7}

How does the tDCS treatment for fibromyalgia differ from other treatments?

The tDCS treatment for fibromyalgia is unique because it involves using a mild electrical current to stimulate the brain's primary motor cortex, combined with exercise, to reduce pain and improve function. This approach is different from typical drug treatments as it directly targets brain activity and is non-invasive, offering a novel way to manage symptoms without medication. ^{1 2 4 8 9}

Research Team

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

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.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Transcranial Direct Current Stimulation Combined With Exercising in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Associated With Functional Exercise Program for Treating Fibromyalgia: A Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation as a treatment for patients with fibromyalgia: a randomized controlled trial. [2022]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Site-specific effects of transcranial direct current stimulation on sleep and pain in fibromyalgia: a randomized, sham-controlled study. [2022]

6. Sweden pubmed.ncbi.nlm.nih.gov

Effiectiveness and safety of transcranial direct current stimulation in fibromyalgia: A systematic review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of add-on transcranial direct current stimulation on pain in Korean patients with fibromyalgia. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

tDCS Task-Oriented Approach Improves Function in Individuals With Fibromyalgia Pain. A Pilot Study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Combined with Aerobic Exercise to Optimize Analgesic Responses in Fibromyalgia: A Randomized Placebo-Controlled Clinical Trial. [2023]