Rules of conduct regarding safety issues
All protocols must be within the standard ones defined in Rossi et al., 2009 for TMS and Antal et al., 2015 for TES. In particular for rTMS it is mandatory to comply with the safety limits in the dimensions of 1) frequency; 2) intensity and 3) duration of the train. These limits can be found in Rossi et al., 2009. In particular, in rTMS experiment all intensity stimulations must be defined as a function of individual motor threshold, that must be calculated with EMG measurement of MEPs in the case of frequencies above 1 Hz.
Monitoring of subjects during and after rTMS and TMS.
Subjects need to be visually monitored constantly during the experiment. As soon as the participant shows any signs of distress, experimenters will stop the experiment. Participants undergoing TMS for their very first time should be observed for 10 minutes before leaving the premises. This means that the participant should NEVER be left alone in the lab during stimulation under any circumstances. If for some reason the experimenter needs to leave the room, then stimulation should be interrupted.
A stated in Rossi et al., 2009 neurophysiological monitoring is NOT required with standard protocols within safety limits.
The responsible researcher's contact should be given to participants, printed on the consent information sheet, in case of need of any clarifications.
Time of the day.
TMS/TES can be performed ONLY during office hours (9-18 in Mattarello and 9-17 in the CERiN).
The only required equipment is earplugs that should be positioned prior to any stimulation.
Session duration and frequency.
A single participant should not undergo single sessions longer than 90 minutes of stimulation (excluding the subject preparation time). Single subjects should not undergo more than 12 TMS/TES sessions in one year.
Emergency management procedure.
The only two conditions that require emergency interventions are syncope and seizure. In both cases the experimenter will have to deal with an unconscious patient.
- The participant is laid on the floor. Blankets and pillows are available in the TBS lab in order to minimize mechanical injury during a seizure and these should be used promptly.
- Experimenters have received training on how to deal with medical emergencies and therefore be able to provide basic first aid. This means to follow all the steps described in the BLS procedure (Check for safety of the operator, check for airways, breathing, circulation, etc.). In the case of rTMS-related medical emergencies, even before starting the first aid procedures, experimenters will immediately alert the supervising physician.
- spTMS and ppTMS are considered safe procedures, therefore any unlikely emergency occurring during those protocols should be treated as an any other emergency happening on the premises (presence of medical personnel not required).
- Soon after the event, once emergency has receded, the supervising person will write an accident/incident report, providing the details of the person involved, location, nature of reported problems and witnesses.
Training procedures for researchers and specific access to the TBS lab infrastructure.
The TBS lab can be accessed by users holding a valid University badge with the necessary authorizations.
TMS/TES must only be performed by researchers trained in its delivery and who maintain an appropriate level of skill through the regular practice of TMS/TES and continuing professional development. In order to use the TBS laboratory, a researcher has to go through these mandatory stages:
- you must have taken and passed the course on Health and Safety in the workplace see LNiF general access rules
- you must have a take a first-level TMS/TES course and passed the following exam and get a qualified training by one of the instructors while assisting the ongoing projects.
- you must have undergone recent training on the management of medical emergencies: a Basic Life Support (BLS) course.
- you must have an "active" project.
- by applying certain established criteria, instructors will then judge their trainee's ability to carry out a study autonomously; if the judgment is positive, the trainee will be allowed to access the lab without supervisor.