Department of Information Engineering, Electronics and Telecommunications, Sapienza University of Rome, Rome, Italy.
INAIL, Italian Workers' Compensation Authority, Rome, Italy.
Med Phys. 2022 May;49(5):3416-3431. doi: 10.1002/mp.15567. Epub 2022 Mar 13.
This study aims to perform a classification and rigorous numerical evaluation of the risks of occupational exposure in the health environment related to the administration of transcranial magnetic stimulation (TMS) treatment. The study investigates the numerically estimated induced electric field that occurs in the human tissues of an operator caused by exposure to the variable magnetic field produced by TMS during treatments. This could be a useful starting point for future risk assessment studies and safety indications in this context.
We performed a review of the actual positions assumed by clinicians during TMS treatments. Three different TMS coils (two circular and one figure-of-eight) were modeled and characterized numerically. Different orientations and positions of each coil with respect to the body of the operator were investigated to evaluate the induced electric (-E) field in the body tissues. The collected data were processed to allow comparison with the safety standards for occupational exposure, as suggested by the International Commission on Non-Ionizing Radiation Protection (ICNIRP) 2010 guidelines.
Under the investigated conditions, exposure to TMS shows some criticalities for the operator performing the treatment. Depending on the model of the TMS coil and its relative position with respect to the operator's body, the numerically estimated E-field could exceed the limits suggested by the ICNIRP 2010 guidelines. We established that the worst-case scenario for the three coils occurs when they are placed in correspondence of the abdomen, with the handle oriented parallel to the body (II orientation). Working at a maximum TMS stimulator output (MSO), the induced E-field is up to 7.32 V/m (circular coil) and up to 1.34 V/m (figure-of-eight coil). The induced E-field can be modulated by the TMS percentage of MSO (%MSO) and by the distance between the source and the operator. At %MSO equal to or below 80%, the figure-of-eight coil was compliant with the ICNIRP limit (1.13 V/m). Conversely, the circular coil causes an induced E-field above the limits, even when powered at a %MSO of 30%. Thus, in the investigated worst-case conditions, an operator working with a circular coil should keep a distance from its edge to be compliant with the guidelines limit, which depends on the selected %MSO: 38 cm at 100%, 32 cm at 80%, 26.8 cm at 50%, and 19.8 cm at 30%. Furthermore, attention should be paid to the induced E-field reached in the operator's hand as the operator typically holds the coil by hand. In fact in the hand, we estimated an induced E-field up to 10 times higher than the limits.
Our numerical results indicate that coil positions, orientations, and distances with respect to the operator's body can determine the levels of induced E-field that exceed the ICNIRP limits. The induced E-field is also modulated by the choice of %MSO, which is related to the TMS application. Even under the best exposure conditions, attention should be paid to the exposure of the hand. These findings highlight the need for future risk assessment studies to provide more safety information for the correct and safe use of TMS devices.
本研究旨在对与经颅磁刺激(TMS)治疗相关的医疗环境中职业暴露风险进行分类和严格的数值评估。该研究调查了在治疗过程中,操作人员暴露于 TMS 产生的时变磁场时,人体组织中出现的数值估计感应电场。这可能是未来风险评估研究和该领域安全指示的一个有用起点。
我们对临床医生在 TMS 治疗中实际采取的体位进行了回顾。对三种不同的 TMS 线圈(两个圆形和一个八字形)进行了数值建模和特征描述。研究了每个线圈相对于操作人员身体的不同方向和位置,以评估身体组织中的感应电场(-E)。收集的数据经过处理后,可与国际非电离辐射防护委员会(ICNIRP)2010 年指南建议的职业暴露安全标准进行比较。
在研究条件下,TMS 治疗对操作人员存在一些风险。取决于 TMS 线圈的型号及其相对于操作人员身体的相对位置,数值估计的 E 场可能会超过 ICNIRP 2010 年指南的建议限值。我们发现,三个线圈的最坏情况出现在线圈位于腹部并与身体平行(II 方向)时。在 TMS 刺激器最大输出(MSO)下,感应 E 场高达 7.32 V/m(圆形线圈)和 1.34 V/m(八字形线圈)。感应 E 场可通过 TMS MSO 的百分比(%MSO)和源与操作人员之间的距离进行调节。当 %MSO 等于或低于 80%时,八字形线圈符合 ICNIRP 限值(1.13 V/m)。相反,即使在 %MSO 为 30%的情况下,圆形线圈也会产生超过限值的感应 E 场。因此,在研究的最坏情况下,操作人员使用圆形线圈时,应保持与线圈边缘的距离以符合指南限值,该限值取决于所选的 %MSO:100%时为 38cm,80%时为 32cm,50%时为 26.8cm,30%时为 19.8cm。此外,应注意操作人员手部感应 E 场,因为操作人员通常用手握住线圈。实际上,我们在手中估计的感应 E 场比限值高 10 倍。
我们的数值结果表明,线圈位置、方向和相对于操作人员身体的距离可以决定超过 ICNIRP 限值的感应 E 场水平。感应 E 场还受到 %MSO 的选择的调节,这与 TMS 的应用有关。即使在最佳暴露条件下,也应注意手部暴露。这些发现强调需要进行未来的风险评估研究,为 TMS 设备的正确和安全使用提供更多的安全信息。