经颅磁刺激治疗脑部：疼痛治疗研究指南
Transcranial magnetic stimulation of the brain: guidelines for pain treatment research.
作者信息
Klein Max M, Treister Roi, Raij Tommi, Pascual-Leone Alvaro, Park Lawrence, Nurmikko Turo, Lenz Fred, Lefaucheur Jean-Pascal, Lang Magdalena, Hallett Mark, Fox Michael, Cudkowicz Merit, Costello Ann, Carr Daniel B, Ayache Samar S, Oaklander Anne Louise
机构信息
Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA US Food and Drug Administration, Center for Devices and Radiological Health, Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Bethesda, MD, USA US National Institutes of Health, National Institute on Mental Health, Experimental Therapeutics and Pathophysiology Branch, Bethesda, MD, USA Pain Research Institute, Neuroscience Research Centre, The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom Department of Neurosurgery, Johns Hopkins Medical Institutions, Baltimore, MD, USA Department of Physiology, Henri Mondor Hospital, Assistance Publique - Hôpitaux de Paris, Créteil, France, EA 4391, Nerve Excitability and Therapeutic Team, Faculty of Medicine, Paris Est Créteil University, Créteil, France, Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA, Departments of Anesthesiology, Medicine, and Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA, Department of Pathology (Neuropathology), Massachusetts General Hospital, Boston, MA, USA.
出版信息
Pain. 2015 Sep;156(9):1601-1614. doi: 10.1097/j.pain.0000000000000210.
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 magnetic stimulation devices are marketed for depression and migraine in the United States and for various indications elsewhere. Although multiple studies report that high-frequency rTMS of the motor cortex reduces neuropathic pain, their quality has been insufficient to support 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 strategies for sham and double blinding. Subjects should have common well-characterized pain conditions amenable to motor cortex rTMS 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, patient and clinician impression of change, and proportions achieving 30% and 50% pain relief. Secondary outcomes could include 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.
认识到电刺激运动皮层可以缓解慢性疼痛，这引发了非侵入性技术的发展。在经颅磁刺激（TMS）中，紧贴头皮放置的电磁线圈会影响皮层下的放电。多日重复经颅磁刺激（rTMS）可以诱导持久的、可能具有治疗作用的脑可塑性。附近有铁磁性或电子植入物是禁忌证。不良反应极小，主要是头痛。单次诱发性癫痫非常罕见。经颅磁刺激设备在美国被用于治疗抑郁症和偏头痛，在其他地方则用于各种适应症。尽管多项研究报告称，对运动皮层进行高频rTMS可减轻神经性疼痛，但其质量不足以支持美国食品药品监督管理局的应用申请。因此，哈佛大学拉德克利夫研究所主办了一次研讨会，征求TMS、疼痛研究和临床试验方面专家的意见。他们建议研究人员对所有TMS参数进行标准化并记录，并改进假刺激和双盲策略。受试者应患有适合运动皮层rTMS治疗的常见且特征明确的疼痛病症，研究应有足够的样本量。他们推荐使用标准化评估工具（如美国国立卫生研究院的PROMIS）以及经过验证的特定病症工具和共识推荐指标（如IMMPACT）。结果应包括疼痛强度和性质、患者和临床医生对变化的印象，以及实现疼痛缓解30%和50%的比例。次要结果可能包括功能、情绪、睡眠和/或生活质量。所需的最低要素包括样本来源、规模和人口统计学特征、招募方法、纳入和排除标准、基线和治疗后的均值及标准差、不良反应、安全问题、停药情况和用药记录。开始治疗后应使用预先指定的统计分析方法对结果进行至少3个月的监测。关键试验可能需要多组合作或注册研究。
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