Transcranial magnetic stimulation of the brain: Guidelines for pain treatment research

Max M. Klein, Roi Treister, Tommi Raij, Alvaro Pascual-Leone, Lawrence Park, Turo Nurmikko, Fred Lenz, Jean Pascal Lefaucheur, Magdalena Lang, Mark Hallett, Michael Fox, Merit Cudkowicz, Ann Costello, Daniel B. Carr, Samar S. Ayache, Anne Louise Oaklander

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Pages (from-to)1601-1614
Number of pages14
Issue number9
StatePublished - 1 Sep 2015
Externally publishedYes

Bibliographical note

Funding Information:
Supported in part by the Radcliffe Institute for Advanced Study and the Samuels Family Foundation, the Public Health Service (K24NS059892, K23NS083741, NS38493, R01HD069776, R01NS073601, R21 MH099196, R21 NS082870, R21 NS085491, R21 HD07616, and U01NS077179) and NINDS intramural support to M. Hallett, the UK National Institute of Health Research (PB-PG-0110-20321) to T. Nurmikko, the Hopkins Neurosurgery Pain Research Institute, the American Academy of Neurology/American Brain Foundation, the Sidney R. Baer Foundation, the Harvard Catalyst 2014;Clinical and Translational Science Center (UL1 RR025758).

Publisher Copyright:
© 2015 International Association for the Study of Pain.


  • Device
  • Human
  • Neuromodulation
  • Neuropathic pain
  • Treatment

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine


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