10 Sessions of Adjunctive Left Prefrontal rTMS Significantly Reduces Fibromyalgia Pain : A Randomized , Controlled , Pilot Study

Transcranial magnetic stimulation (TMS) of the prefrontal cortex can cause changes in acute pain perception. Several weeks of daily left prefrontal TMS has been shown to treat depression. We recruited 20 patients with fibromyalgia, defined by American College of Rheumatology criteria, and randomized them to receive 4000 pulses at 10Hz TMS (n=10), or sham TMS (n=10) treatment for 10 sessions over 2 weeks along with their standard medications, which were fixed and stable for at least 4 weeks before starting sessions. Subjects recorded daily pain, mood, and activity. Blinded raters assessed pain, mood, functional status, and tender points weekly with the Brief Pain Inventory, Hamilton Depression Rating Scale, and Fibromyalgia Impact Questionnaire. No statistically significant differences between groups were observed. Patients who received active TMS had a mean 29% (statistically significant) reduction in pain symptoms in comparison to their baseline pain. Sham TMS participants had a 4% nonsignificant change in daily pain from their baseline pain. At 2 weeks after treatment, there was a significant improvement in depression symptoms in the active group compared to baseline. Pain reduction preceded antidepressant effects. TMS was well tolerated, with few side effects. Further studies that address study limitations are needed to determine whether daily prefrontal TMS may be an effective, durable, and clinically useful treatment for fibromyalgia symptoms. Address correspondence to Dr. Short at Institute of Psychiatry, MUSC, 67 President St, PO Box 250861, Charleston, SC 29425. shorteb@musc.edu 843 792 0199, 843 792 5702 (fax). Disclosures: A Neopulse machine, purchased by the BSL from previous studies, was employed for the TMS-fibromyalgia trial described in the manuscript. The equipment was not loaned and there was no industry involvement or sponsorship. Dr. George has received no compensation from any TMS manufacturer for the past 5 years, and has no equity in any device or pharmaceutical company. Following a competitive bid and request involving all TMS manufacturers, Neuronetics Inc (Malvern, PA) was selected and loaned the TMS devices, head-holders and coils for the OPT-TMS trial (not described in this manuscript.) Dr. George reports research grants in the past 5 years from Glaxo-Smith Kline, Jazz Pharmaceuticals, Brainsway, Cephos, and Force Protection. He has been an unpaid advisor to Brainsonix, Brainsway, Neuronetics, Neostim and Neosync (as they make products related to TMS), and a paid advisor to Jazz, Cyberonics, Neuropace, and Puretech ventures. The full amount of his advisory income has never been more than 10% of his university salary. MUSC has 2 patent applications in Dr. George’s name on combining TMS with MRI imaging. All other authors have nothing to disclose and no conflicts of interest. NIH Public Access Author Manuscript Pain. Author manuscript; available in PMC 2012 November 1. Published in final edited form as: Pain. 2011 November ; 152(11): 2477–2484. doi:10.1016/j.pain. 2011.05. 033. N IH PA Athor M anscript N IH PA Athor M anscript N IH PA Athor M anscript