rTMS for Fibromyalgia

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention

Summary

This trial investigates the neurophysiology of fibromyalgia to find potential biomarkers for diagnosis & explore if transcranial magnetic stimulation can improve pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The sham procedure has minimal risk as it mimics rTMS without delivering actual stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Fibromyalgia impact questionnaire (FIQ)

Change in PROMIS-29 v2.0 Profile

Secondary study objectives

Change in Motor-evoked potentials (MEPs)

Change in Pain catastrophizing scale-EN-SF

Change in Patient Health Questionnaire-4 (PHQ-4)

+7 more

Trial Design

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.

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