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Transcranial magnetic stimulation of the brain: guidelines for pain treatment research
Max M Klein1, Roi Treister, Tommi Raij
1Department 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.
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 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.
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