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TMS治疗疼痛研究2015 指南
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Comprehensive Review Transcranial magnetic stimulation of the brain: guidelines for pain treatment research Max M. Kleina,*, Roi Treistera, Tommi Raijb, Alvaro Pascual-Leonec, Lawrence Parkd,e, Turo Nurmikkof, Fred Lenzg, Jean-Pascal Lefaucheurh,i, Magdalena Langa, Mark Hallettj, Michael Foxa,b,c, Merit Cudkowicza, Ann Costellod, Daniel B. Carrk, Samar S. Ayacheh,i, Anne Louise Oaklandera,l Abstract Recognizing that electrically stimulating the motor cortex could relieve chronic pain sparked development of noninvasive technologies. In transcranial magnetic stimulation (TMS), electromagnetic coils held against the scalp influence underlying cortical firing. Multiday repetitive transcranial magnetic stimulation (rTMS) can induce long-lasting, potentially therapeutic brain plasticity. Nearby ferromagnetic or electronic implants are contraindications. Adverse effects are minimal, primarily headaches. Single provoked seizures are very rare. Transcranial magneticstimulationdevicesaremarketedfordepressionandmigraineintheUnitedStatesandforvariousindicationselsewhere.Although multiplestudiesreportthathigh-frequencyrTMSofthemotorcortexreducesneuropathicpain,theirqualityhasbeeninsufficienttosupport Food and Drug Administration application. Harvard’s Radcliffe Institute therefore sponsored a workshop to solicit advice from experts in TMS, pain research, and clinical trials. They recommended that researchers standardize and document all TMS parameters and improve strategiesforshamanddoubleblinding.Subjectsshouldhavecommonwell-characterizedpainconditionsamenabletomotorcortexrTMS and studies should be adequately powered. They recommended standardized assessment tools (eg, NIH’s PROMIS) plus validated condition-specific instruments and consensus-recommended metrics (eg, IMMPACT). Outcomes should include pain intensity and qualities,patientandclinicianimpressionofchange,andproportionsachieving30%and50%painrelief.Secondaryoutcomescouldinclude function, mood, sleep, and/or quality of life. Minimum required elements include sample sources, sizes, and demographics, recruitment methods, inclusion and exclusion criteria, baseline and posttreatment means and SD, adverse effects, safety concerns, discontinuations, and medication-usage records. Outcomes should be monitored for at least 3 months after initiation with prespecified statistical analyses. Multigroup collaborations or registry studies may be needed for pivotal trials. Keywords:Neuropathic pain, Neuromodulation, Treatment, Human, Device 1. Transcranial magnetic stimulation: principles and applications Transcranial magnetic stimulation (TMS) is being explored as a noninvasive alternative to invasive neurostimulation techniques (such as deep brain stimulation (DBS) and epidural cortical stimulation) for treating neurological disorders and exploring brain function. First demonstrated in 1985,13TMS uses electromagnetic induction to electrically influence nearby cells. Strong effects can depolarize neurons sufficiently to trigger action potentials. Low- intensity TMS seems to mostly stimulate low-threshold inhibitory interneurons, whereas higher intensities excite projection neu- rons.92Transcranial magnetic stimulation pulses can be applied singly, but for therapeutic use, multiple pulses are rapidly applied (repetitive transcranial magnetic stimulation [rTMS]). 1.1. Insights from studies of invasive brain stimulation for treating pain Transcranial magnetic stimulation emerged from experience with invasive brain stimulation. Neurosurgical motor cortex stimulation (MCS) and DBS are proven effective for treating chronic pain (typically defined as more than 40% reduction of pain scores for at least 12 months after implantation). Epidural MCS involves surgically opening the skull to attach an electrode array to dura directly above the motor cortex. Subdural Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. a Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA, bAthinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA, cBerenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA, dUS Food and Drug Administration, Center for Devices and Radiological Health, Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Bethesda, MD, USA, eUS National Institutes of Health, National Institute on Mental Health, Experimental Therapeutics and Pathophysiology Branch, Bethesda, MD, USA, fPain Research Institute, Neuroscience Research Centre, The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom, gDepartment of Neurosurgery, Johns Hopkins Medical Institutions, Baltimore, MD, USA, hDepartment of Physiology, Henri Mondor Hospital, Assistance Publique - H opitauxdeParis,Cr eteil,France,iEA4391,NerveExcitabilityandTherapeuticTeam, FacultyofMedicine,ParisEstCr eteilUniversity,Cr eteil,France,jHumanMotorControl Section, Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA, kDepartments of Anesthesiology, Medicine, and Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA, lDepartment of Pathology (Neuropathology), Massachusetts General Hospital, Boston, MA, USA *Corresponding author. Address: Department of Neurology, Massachusetts General Hospital, 275 Charles St/Warren Bldg. 310, Harvard Medical School, Boston, MA 02114, USA. Tel.: 617-233-4476; fax: 617-726-0473. E-mail address: mklein@mgh.harvard.edu (M. M. Klein). PAIN 156 (2015) 1601–1614 2015 International Association for the Study of Pain http://dx.doi.org/10.1097/j.pain.0000000000000210 September 2015·Volume 156·Number 9www.painjournalonline.com1601 Copyright?2015 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.

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