At a glance
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Investigating the Neurobiological Contributions to Pain in Patients With Fibromyalgia
In Brief
A clinical study evaluating Active Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) and Sham Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) for Fibromyalgia. Completed, enrolled 36 participants across 1 site.
Detailed Summary
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 cTMS protocol will alter pain in individuals with fibromyalgia.
Study Details
Timeline
Arms & Interventions
Controlled Pulse Parameter Transcranial Magnetic Stimulation (cTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. cTMS 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.
Sham cTMS 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 cTMS. 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.
Interventions
cTMS is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The first dorsal interosseous (FDI) muscle of the left motor cortex will be targeted using neuronavigation software. 2000 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right FDI muscle. The delivery of cTMS requires 11 minutes in total.
A sham coil will be utilized for the sham cTMS condition. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active. The location and all other parameters of Sham cTMS will be identical to Active cTMS.