60 Participants Needed

rTMS for Fibromyalgia

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Fibromyalgia is a syndrome associated with fatigue and chronic pain, leading to significant physical limitations and impaired quality of life. There are several challenges that complicate the diagnosis and management of fibromyalgia. The etiology is not well defined, as there are several proposed factors that may trigger the genesis of pain in fibromyalgia including physical and/or emotional life stressors, and genetic predispositions involving neuromodulator pathways. Chronic pain in fibromyalgia arises in the absence of tissue pathology, and consequently a lack of consensus on reliable diagnostic criteria. Understanding the neurophysiology of fibromyalgia would aid in the discovery of objective biomarkers for diagnosis. Therefore, the goals of this study are to: 1. Compare the neurophysiological responses in fibromyalgia compared to healthy controls. 2. Determine whether a two-week rTMS protocol will alter pain in individuals with fibromyalgia.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that high-frequency rTMS can significantly improve the quality of life and health status in people with fibromyalgia. Studies comparing rTMS to a sham (fake) treatment found that it helps reduce pain and improve overall well-being.12345

Is rTMS safe for humans?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, with no serious adverse events reported in studies involving fibromyalgia patients. It has been used safely in various conditions, and while minor side effects can occur, they are typically mild and temporary.13678

How does rTMS treatment differ from other treatments for fibromyalgia?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a unique treatment for fibromyalgia because it is a non-invasive brain stimulation technique that targets specific brain areas to improve pain and mood, unlike traditional medications. It has shown promise in improving quality of life and health status in fibromyalgia patients, especially when other treatments are not effective.1391011

Eligibility Criteria

This trial is for adults aged 18-65 who have been diagnosed with fibromyalgia, a condition causing fatigue and chronic pain. It's not open to those with other chronic pain conditions or who can't safely undergo Transcranial Magnetic Stimulation (TMS) due to certain health risks.

Inclusion Criteria

I am between 18 and 65 years old.

Exclusion Criteria

I have no health conditions that prevent me from undergoing TMS.
I have chronic pain not caused by fibromyalgia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment for fibromyalgia, with active and sham groups receiving 10 Hz rTMS approximately 5 days per week for 2 weeks

2 weeks
10 visits (in-person)

Follow-up

Participants are monitored for changes in neurophysiological responses and pain levels after treatment

2 weeks

Treatment Details

Interventions

  • Active Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
Trial OverviewThe study tests how Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, affects the neurophysiology of fibromyalgia patients compared to inactive treatment. Participants will receive two weeks of either active rTMS or sham (inactive) therapy.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active rTMSActive Control1 Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered at 10 Hz, 1500 pulses targeting the hand representation of the left primary motor cortex. rTMS delivery will require \~11 min to complete. In Experiment 1, this intervention will be performed for 1 session (\~11min). In Experiment 2, this intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.
Group II: Sham rTMSPlacebo Group1 Intervention
Sham rTMS will be delivered at as a placebo control. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active rTMS. In Experiment 2, this intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Active Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as rTMS for:
  • Major Depressive Disorder
  • Obsessive-Compulsive Disorder
  • Migraines
🇪🇺
Approved in European Union as rTMS for:
  • Major Depressive Disorder
  • Anxiety Disorders
🇨🇦
Approved in Canada as rTMS for:
  • Major Depressive Disorder
  • Obsessive-Compulsive Disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Findings from Research

In a study of 38 fibromyalgia patients, those receiving high-frequency rTMS showed significant improvements in quality of life (QoL) after 10 weeks compared to those receiving sham stimulation, particularly in emotional and social aspects.
The improvement in QoL was linked to increased metabolism in the right medial temporal area of the brain, suggesting a neural basis for the emotional benefits of rTMS treatment.
rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate.Boyer, L., Dousset, A., Roussel, P., et al.[2022]
A systematic review of 7 high-quality randomized controlled trials involving 217 patients found that 10-Hz repetitive transcranial magnetic stimulation (rTMS) significantly reduced pain and improved quality of life in individuals with fibromyalgia compared to sham stimulation.
While 10-Hz rTMS effectively alleviated pain (SMD=-0.72) and enhanced quality of life (SMD=-0.70), it did not show a significant impact on depression levels (SMD=-0.23), indicating its primary benefit lies in pain management rather than mood improvement.
Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation at 10 Hz in Fibromyalgia: A Systematic Review and Meta-analysis.Zhu, PA., Xie, JY., Liu, H., et al.[2023]
In a study of 30 female patients with fibromyalgia, both high-frequency rTMS protocols (targeting the primary motor cortex and dorsolateral prefrontal cortex) led to significant improvements in pain, quality of life, and depression compared to a sham treatment.
The group receiving rTMS targeting the primary motor cortex showed the greatest reduction in pain, while the dorsolateral prefrontal cortex group had more significant improvements in physical role functioning, highlighting the potential of rTMS as an effective intervention for fibromyalgia symptoms.
Is high-frequency repetitive transcranial magnetic stimulation of the left primary motor cortex superior to the stimulation of the left dorsolateral prefrontal cortex in fibromyalgia syndrome?Altas, EU., Askin, A., Beşiroğlu, L., et al.[2020]

References

Effects of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex of Individuals with Fibromyalgia: A Systematic Review and Meta-Analysis. [2022]
rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. [2022]
Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation at 10 Hz in Fibromyalgia: A Systematic Review and Meta-analysis. [2023]
Is high-frequency repetitive transcranial magnetic stimulation of the left primary motor cortex superior to the stimulation of the left dorsolateral prefrontal cortex in fibromyalgia syndrome? [2020]
Efficacy of transcranial direct current stimulation and repetitive transcranial magnetic stimulation for treating fibromyalgia syndrome: a systematic review. [2022]
Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials. [2022]
Efficacy of Repetitive Transcranial Magnetic Stimulation in Fibromyalgia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]
Sham or real--post hoc estimation of stimulation condition in a randomized transcranial magnetic stimulation trial. [2015]
Evidence for the improvement of fatigue in fibromyalgia: A 4-week left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation randomized-controlled trial. [2019]
Analgesic effects of repetitive transcranial magnetic stimulation on modified 2010 criteria-diagnosed fibromyalgia: Pilot study. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
The effect of repetitive transcranial magnetic stimulation on fibromyalgia: a randomized sham-controlled trial with 1-mo follow-up. [2022]