rTMS for Fibromyalgia
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rTMS treatment for fibromyalgia, with active and sham groups receiving 10 Hz rTMS approximately 5 days per week for 2 weeks
Follow-up
Participants are monitored for changes in neurophysiological responses and pain levels after treatment
Treatment Details
Interventions
- Active Repetitive Transcranial Magnetic Stimulation (rTMS)
- Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
Active Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada for the following indications:
- Major Depressive Disorder
- Obsessive-Compulsive Disorder
- Migraines
- Major Depressive Disorder
- Anxiety Disorders
- Major Depressive Disorder
- Obsessive-Compulsive Disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor