Access to the TBS lab
For general access see Mandatory Requirements at LNiF general access rules
The lab is open only during office hours (9-18 in Mattarello and 9-17 in CERiN). The lab can be accessed by users holding a valid University badge with the necessary authorizations; in particular, it is mandatory for anyone accessing the lab to have successfully accomplished the "Course on Health and Safety in the workplace" of University of Trento. Users (Researchers and PhD students) are allowed to access instruments only after appropriate (mandatory) training about TMS & TES procedures and lab rules. To access, the TBS lab, without supervision it is necessary to have a basic life support (BLS) certification. Bachelor and master students are not allowed to work in the facility unattended.
Who can directly deliver TMS/TES?
The person who practically delivers spTMS, ppTMS, rTMS and TES does not need to be a medical professional (MD) or a specialized technician.
TMS or TES must only be performed by researchers who have trained in its delivery and who maintain an appropriate level of skill through the regular practice of TMS or tES. Morever they must have undergone recent training on the management of medical emergencies: a Basic Life Support (BLS) course.
Such courses are organized by a specialised company, in agreement with the Responsible of the lab and with Valeria Nencini email@example.com from the CIMeC administration.
Differences between sp/ppTMS and rTMS
spTMS and ppTMS
They are established as a safe and useful tools for investigating various aspects of human neurophysiology in healthy participants (Rossi et al., 2009). spTMS and ppTMS can be carried out in non-medical settings and in the absence of medical supervision.
It potentially carries a significant risk and, therefore, require medical supervision and the presence of emergencies facilities.
Duties of the experimenter.
Book a timeslot for the experiment through an electronic scheduling system. This can only be done if the researcher has the necessary authorizations and a project number that documents the approval of the study in question by CIMeC and the Ethical Committee.
Screening on TMS/TES participants using the Italian or the English version of the approved questionnaire (see Reference material for download).
Providing the participant with documentation for informed consent.
Signing of the consent form.
Signing of the privacy statement.
Ensure the proper handling of stimulation devices. This includes making sure that stimulation stays within the published safety limits as in Rossi et al., 2009 for TMS, and that participants wear ear protection and Antal et al., 2017 for tES.
- Monitor participants for signs of distress e.g., headache, dizziness. This means that it is duty of the experimenter to make sure that there is an operator ALWAYS present in the lab while stimulating.
- Survey on TMS/TES using the Italian or the English version (see Reference material for download). Document all incidents including minor discomfort of participants related to the experiment.
- Make sure that the operators are familiar with the emergency procedure (see Rules of conduct regarding safety issues)
- In case of emergency provide first assistance, apply the procedure detailed in Rules of conduct regarding safety issues.
Duties of the supervising physician
For some protocols (i.e., rTMS) a supervising physician is needed.
- The supervising physician is required to perform the medical screening on TMS participants using the Italian or the English version of the approved questionnaire (see Reference material for download on the wiki page). By signing the screening form the supervising physician will assume liability for the experiment. Therefore it is required to have insurance for professional damage to a third party.
- Supervising physicians will have to get personally in touch with participants only in case of emergencies during rTMS
- Provide first aid in case of an incident during the experiment and after the experiment as long as the participant is on CiMeC premises
- Be available for providing additional information on the circumstances of any occurring incident. The availability of a supervising physician for any rTMS study at LNiF is ensured by the following procedure: a physician authorized for supervising rTMS studies will mark her or his availability in an electronic scheduling system. The researcher responsible for the rTMS study in question will book time slots in which a physician is available. The researcher contacts the authorized supervising physician before the start of the experiment in order to perform screening and to ensure the physicians presence on CIMeC premises. In that contact the physician commits his full availability to consultation and emergency services described in point 3 above.
- Document all incidents including minor discomfort of participants related to the experiment on the related part of the screening questionnaire.