rTMS for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

No Placebo Group

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.

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.

Participant Groups

The 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.

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, Australia for the following indications:

🇺🇸 Approved in United States as rTMS for: