All users of the TMS equipment in the ALBMC NeuroModulation Lab are required to have TMS safety training completed here at the Brain Mapping Center.
Most TMS protocols, when implemented properly, are considered minimal risk activities. However, because many TMS protocols exist, each protocol must undergo its own individual safety analysis with TMS Lab personnel. In addition, in order to minimize risk, only properly trained and certified TMS personnel are allowed to administer TMS to human subjects. This certification includes practical training on use of TMS, formal safety training and training as a first-responder in case of an emergency.
TMS Protocols
Many TMS protocols exist and the TMS Lab personnel should be involved in the design and implementation of TMS studies in the lab. The most common protocols in use are single-pulse TMS, paired-pulse TMS, low-frequency repetitive TMS, high-frequency repetitive TMS, and theta-burst TMS. Each protocol is defined by a combination of TMS intensity, frequency, duration of stimulation, and pattern of stimulation (continuous vs intermittent stimulation).
In general, higher intensities, higher frequencies, and longer durations of stimulation carry higher risk. All procotols currently in use are done within limits of safety guidelines first established in 1998 (Wassermann 1998; see Table 1). These guidelines have been reaffirmed by the recent publication of a comprehensive and consensus review of TMS safety, ethics, and application in research (Rossi et al 2009) which essentially incorporates and supercedes the Wassermann 1998 article. Table 4 in the review article reproduces this table. The Rossi et al 2009 safety article is required reading for anyone who wishes to use TMS in a research study.
Standard TMS risks and exclusions:
Standard risks disclosed in all TMS studies in our lab (see specific IRB for details):
- headaches, neck aches
- hearing threshold shifts
- heating of metal on the scalp/head
- syncope (fainting)
- accidental seizures (very rare)
- unforeseen potential events in research protocols
General exclusion criteria (see specific IRB for details)
- age >= 18 years old
· metals in head (except dental fillings)
. history of seizures or 1st degree relative with history of seizures
. medications that lower seizure threshold
· a serious or active medical, neurological, or psychiatric illness
· pregnancy
Please consult with TMS Lab personnel if you have any questions.
Readings:
Rossi, S., M. Hallett, et al. (2009). "Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research." Clin Neurophysiol 120(12): 2008-2039.
Wassermann, E. M. (1998). "Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996." Electroencephalogr Clin Neurophysiol 108(1): 1-16.
TMS Safety Training
For information on safety training please contact TMS Lab personnel
Most TMS protocols, when implemented properly, are considered minimal risk activities. However, because many TMS protocols exist, each protocol must undergo its own individual safety analysis with TMS Lab personnel. In addition, in order to minimize risk, only properly trained and certified TMS personnel are allowed to administer TMS to human subjects. This certification includes practical training on use of TMS, formal safety training and training as a first-responder in case of an emergency.
Your lab must have one of the following:
An active TMS study here at the ALBMC
A study must be submitted and under review by BMC faculty
Click here to submit a study to the ALBMC database (requires a
database account)
Safety training is a 6 step process and typically takes 2-3 weeks to complete.
TMS Safety Course and Test
Go to the Brain Mapping Center for a 1.5 hour session TMS safety course which will be followed by a test.
TMS Orientation
After passing the TMS safety quiz, you will be scheduled for a 30 minute orientation session that will include reviewing TMS Safety issues in the TMS environment AND some basic TMS equipment operation.
Final TMS Safety Walk-through
After your TMS Orientation is completed you will then schedule a “Final Safety Walk-through” with Dr. Iacoboni (contact information for scheduling the walk-through will be given out at the completion of the TMS orientation session).
This is typically a 30 minute Question and Answer session in which you will be asked questions relevant to TMS safety
Many TMS protocols exist and the TMS Lab personnel should be involved in the design and implementation of TMS studies in the lab. The most common protocols in use are single-pulse TMS, paired-pulse TMS, low-frequency repetitive TMS, high-frequency repetitive TMS, and theta-burst TMS. Each protocol is defined by a combination of TMS intensity, frequency, duration of stimulation, and pattern of stimulation (continuous vs intermittent stimulation).
In general, higher intensities, higher frequencies, and longer durations of stimulation carry higher risk. All procotols currently in use are done within limits of safety guidelines first established in 1998 (Wassermann 1998; see Table 1). These guidelines have been reaffirmed by the recent publication of a comprehensive and consensus review of TMS safety, ethics, and application in research (Rossi et al 2009) which essentially incorporates and supercedes the Wassermann 1998 article. Table 4 in the review article reproduces this table. The Rossi et al 2009 safety article is required reading for anyone who wishes to use TMS in a research study.
Standard risks disclosed in all TMS studies in our lab (see specific IRB for details):
headaches, neck aches
hearing threshold shifts
heating of metal on the scalp/head
syncope (fainting)
accidental seizures (very rare)
unforeseen potential events in research protocols
General exclusion criteria (see specific IRB for details)
age >= 18 years old
metals in head (except dental fillings)
history of seizures or 1st degree relative with history of seizures
medications that lower seizure threshold
a serious or active medical, neurological, or psychiatric illness
pregnancy
Please consult with TMS Lab personnel if you have any questions.