TMS must not harm participants: guidelines for evaluating TMS protocol safety.

Abstract

Transcranial magnetic stimulation (TMS) can modulate a targeted brain region to assess whether that region is involved in a cognitive process. When TMS is employed in cognitive neuroscience, participants are typically healthy volunteers, and the technique is described as noninvasive. However, TMS parameters can be set such that stimulation produces long-lasting effects. Critically, TMS effects that have any possibility of lasting beyond a participant's time in the lab are potentially harmful. In this editorial, evidence is considered that indicates a 20-Hz multi-day TMS protocol has long-lasting effects, and a continuous theta-burst stimulation protocol needs further testing before it is deemed noninvasive. The following guidelines are provided for TMS protocol evaluation: 1) Effects must be shown to completely dissipate before participants leave the lab by testing well beyond the expected duration. 2) Participants should complete a cognitive test battery before TMS and after the effects are expected to dissipate. 3) Protocols should not be employed that produce effects lasting longer than the time in the lab. 4) The number of participants should ensure error bars are small, and results generalize to the population. 5) Results should be assessed at the group and individual-participant level, and effects should dissipate for every participant. 6) Bayesian analysis should be conducted to evaluate evidence in favor of the null hypothesis. 7) Effects should be assessed in multiple cortical regions. It is hoped that these guidelines will be employed to ensure the continued use of TMS as a valuable tool in the field of cognitive neuroscience.