Definition of study types to be done with TMS/TES


  • Class 1


Direct benefit, potential high risk: Studies in patients with diagnostic or therapeutic primary objective with potential direct individual clinical benefit. Normal subjects should not ordinarily participate in such studies, and the risk level for patients can be theoretically high.


  • Class 2


Indirect benefit, moderate risk: Studies in patients where the potential clinical benefit is more speculative or where no clinical benefit is expected. In these studies, regimens that will place subjects at significant risk should employ only patients and not normal subjects.


  • Class 3


Indirect benefit, low risk: Studies in normal subjects and patients that are expected to yield important data on brain physiology or on safety, but have no immediate relevance to clinical problems. Normal volunteers should be permitted to participate in rTMS research when it is likely to produce data that are of outstanding scientific or clinical value.


What kind of studies can be done in TBS Lab?

  • LNiF:

Mattarello: TMS/TES will not be used as a diagnostic nor as a therapeutic devices, but rather as experimental tools in a research environment in Class 3 studies. TMS/TES will be conducted:
only on healthy volunteers, with full informed consent of the participant and within protocols:

Rovereto: TMS/TES will be used as a therapeutic devices (but not as diagnostic device) in Class 1, 2 and 3 studies. TMS/TES will be conducted on healthy volunteers and on patients, with full informed consent of the participant and within protocols:

Created by elena.tonolli.1. Last Modification: Monday 15 of January, 2018 15:43:33 CET by System Administrator.