ISTS CONSENSUS STATEMENTS ON MANAGING THE RISKS OF rTMS

as adopted by the committee 7/18/02

Repetitive transcranial magnetic stimulation (rTMS), defined as the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function, is an experimental medical intervention. rTMS is currently used to probe various aspects of brain function in the context of research studies approved by local ethics committees. rTMS is also under investigation as a potential treatment for various neurological and psychiatric disorders. In light of the growing interest in using rTMS in a variety of experimental and therapeutic settings, the ISTS has recognized the need to formulate a consensus statement to assist the field in developing guidelines for its safe application. Whether the intended use is experimental or therapeutic, certain principles regarding the safety of rTMS apply. This statement is not aimed at guiding the therapeutic use of rTMS in any given condition or its application in any research paradigm, but rather is meant to apply broadly wherever rTMS is used.

rTMS has significant risks, most importantly that of producing epileptic seizures. The degree of risk varies with the dosing parameters and individual subject factors. Therefore, rTMS should be administered only under a licensed physician's orders, i.e. by prescription or through some other mechanism that makes a physician directly responsible for its administration to the individual patient or research subject. Because rTMS has potential behavior-changing effects, undesirable side-effects, and therapeutic impact, careful assessment of the risk and appropriateness of rTMS in each clinical or scientific context is critical and can only be made by, or in consultation with, a physician knowledgeable and experienced in the use of rTMS and fully trained in neurology, psychiatry or another appropriate specialty.

rTMS should only be administered under the supervision of an appropriately trained and licensed physician. This does not mean that a physician must be physically present in the laboratory for every study. However, expert medical assistance should be immediately available. A plan for medical supervision should be formed prior to the application of rTMS. This plan should address, but not necessarily be limited to, the following issues: procedures for screening subjects for risk factors prior to TMS, individual assessment of risks and potential benefits in patients, the informed consent process, setting of rTMS stimulation parameters, and monitoring of subjects during and after rTMS.

Those who administer rTMS should be trained as “first responders” in order to render appropriate care in the event of seizure. rTMS should be performed in a medical setting with appropriate emergency facilities to manage seizures and their consequences. Patients and research subjects should be continuously monitored during the administration of rTMS for signs of epileptic activity or other adverse effects by a trained individual, according to criteria established in the clinical or experimental protocol. This monitoring may include electrophysiological recording and/or visual inspection. During the informed consent process, patients and study participants should be informed of the risk of seizure and its possible medical and social consequences. The dosage of rTMS should generally be limited by published safety guidelines (e.g., Wassermann, Clin Neurophysiol, 1998;108:1 or any subsequent updates). If there is a compelling scientific or clinical reason to exceed such guidelines, the rationale for doing so should be considered carefully, documented and the patients or study participants should be informed that they may be at higher risk for seizure.

The long-term risks of rTMS are not known. However, the limited data available at this time (2002) from repeated application of high intensity, time-varying magnetic fields to humans, as in magnetic resonance imaging, do no suggest that they are significant.

The use of rTMS should comply with regulations put forward by local regulatory bodies, medical professional organizations, and medical licensing boards.

 

©The ISTS Consensus Committee:

Bob Belmaker (ISRAEL), Mark George (USA), Paul Fitzgerald (AUSTRALIA), Sarah Lisanby (USA), Alvaro Pascual-Leone (USA), Thomas Schlaepfer (SWITZERLAND, USA), Eric Wassermann (USA)

Ultima actualización: Sat 17th 2015f October 2015 by Dr. Ricardo Rozados
Copyright © 2001 psicomag.com - Dr. Ricardo Rozados - All rights reserved.
Design by RedNodo.com