None listed
Conditions
Brief summary
Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, is an approved treatment option for patients with depression in the Canada and several EU nations, with significant evidence demonstrating greater clinical outcomes following longer treatment courses. For patients with fibromyalgia, studies suggest rTMS may also offer a novel treatment approach for pain relief. However these effects are short-lasting thereby limiting its clinical application. Yet no studies to date have explored the effects of a treatment course of similar duration to that used in depression. In addition, there is a dearth of literature exploring target sites other than the motor cortex, such as the dorsolateral prefrontal cortex (DLPFC); a brain region directly implicated in the control of pain perception. In the proposed world-first study, we will carry-out a randomised double-blind placebo-controlled trial to assess the use of an rTMS treatment course applied to the DLPFC in patients who suffer from fibromyalgia. To do so, we will recruit a total of 40 patients with a diagnosis of fibromyalgia who will undergo a blind 4-week acute rTMS daily treatment course. We expect our proposed treatment course of rTMS to the DLPFC in patients with fibromyalgia will provide a model for an interventional treatment course that may be extended to other pain syndromes. Thereby reducing dependence on pharmaceutical treatments in patients who suffer from chronic pain and increasing quality of life for the millions of chronic pain sufferer's worldwide.
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS).
rTMS will be administered using the Magventure Magpro or NeuroStar TMS Therapy System (Neuronetics Inc). Prior to the administration of rTMS, each participants resting motor threshold (RMT) will be determined according to standard published methods.
Participants will undergo a total of 20 treatments, daily (mon-fri) for 4 weeks. In each treatment, participants will receive 75 trains of 4 second duration with a frequency of 10 Hz. Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will be administered using the Magventure Magpro or NeuroStar TMS Therapy System (Neuronetics Inc). Prior to the administration of rTMS, each participants resting motor threshold (RMT) will be determined according to standard published methods. Participants will undergo a total of 20 treatments, daily (mon-fri) for 4 weeks. In each treatment, participants will receive 75 trains of 4 second duration with a frequency of 10 Hz. Stimulation intensity will be set at 120% RMT and will applied to the dorsolateral prefrontal cortex. The above protocol is in compliance with current published rTMS safety guidelines. Participants will undergo an assessment at baseline, at the end of weeks 1, 2, 3 and 4, and at a subsequent one -month follow-up. The clinical outcome of rTMS treatments will be determined through these assessments.
Sponsors
Dr Bernadette Fitzgibbon
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be included if they: * are aged between 18-65 years, * meet American College of Rheumatology Fibromyalgia Scale (2010) diagnostic criteria for Fibromyalgia * have experienced symptoms for > 6 months * have had no change in medication in the four weeks prior to trial initiation.
Exclusion criteria
* History of epilepsy or seizure disorder * History of serious head injury * Metal in the head (outside of the mouth) * Medical implants in the body * History or diagnosis of neurological/psychiatric illness * Specific pathological entities, such as infection, neoplasm, metastasis, osteoporosis, rheumatoid arthritis or fracture * Additional co-existing musculoskeletal conditions * Pregnant * Professional driver or machine operator.
Outcome results
None listed