TY - JOUR
T1 - Seizure risk with repetitive TMS
T2 - Survey results from over a half-million treatment sessions
AU - Taylor, Joseph J.
AU - Newberger, Noam G.
AU - Stern, Adam P.
AU - Phillips, Angela
AU - Feifel, David
AU - Betensky, Rebecca A.
AU - Press, Daniel Z.
N1 - Funding Information:
JT: I have no conflicts of interest. Part of my time was supported by the Sidney R. Baer, Jr. Foundation.
Publisher Copyright:
© 2021 The Authors
PY - 2021/7/1
Y1 - 2021/7/1
N2 - Background: Seizures are rare during repetitive transcranial magnetic stimulation (rTMS) treatment, but estimating risk is difficult because of study heterogeneity and sampling limitations. Moreover, there are few studies comparing rates between device manufacturers. Objective: The objective of this study was to calculate rTMS seizure rates across various FDA-cleared devices in naturalistic clinical settings. Methods: In July and August 2018, approximately 500 members of the Clinical TMS Society (CTMSS) were electronically surveyed about seizures in their practices. Seizures were distinguished from non-seizures by a remote semi-structured interview with a Board-certified neurologist and Co-Chair of the CTMSS Standards Committee. Exact Poisson calculations were used to estimate seizure rates and confidence intervals across the four most widely used manufacturers. Results: The survey was completed by 134 members, with 9 responses excluded because of data inconsistencies. In total, 18 seizures were reported in 586,656 sessions and 25,526 patients across all device manufacturers. The overall seizure rate was 0.31 (95% CI: 0.18, 0.48) per 10,000 sessions, and 0.71 (95% CI: 0.42, 1.11) per 1000 patients. The Brainsway H-coil seizure rate of 5.56 per 1000 patients (95% CI: 2.77,9.95) was significantly higher (p < 0.001) than the three most widely used figure- 8 coil devices’ combined seizure rate of 0.14 per 1000 patients (95% CI: 0.01, 0.51). Conclusion: The absolute risk of a seizure with rTMS is low, but generic Brainsway H-coil treatment appears to be associated with a higher relative risk than generic figure- 8 coil treatment. Well-designed prospective studies are warranted to further investigate this risk.
AB - Background: Seizures are rare during repetitive transcranial magnetic stimulation (rTMS) treatment, but estimating risk is difficult because of study heterogeneity and sampling limitations. Moreover, there are few studies comparing rates between device manufacturers. Objective: The objective of this study was to calculate rTMS seizure rates across various FDA-cleared devices in naturalistic clinical settings. Methods: In July and August 2018, approximately 500 members of the Clinical TMS Society (CTMSS) were electronically surveyed about seizures in their practices. Seizures were distinguished from non-seizures by a remote semi-structured interview with a Board-certified neurologist and Co-Chair of the CTMSS Standards Committee. Exact Poisson calculations were used to estimate seizure rates and confidence intervals across the four most widely used manufacturers. Results: The survey was completed by 134 members, with 9 responses excluded because of data inconsistencies. In total, 18 seizures were reported in 586,656 sessions and 25,526 patients across all device manufacturers. The overall seizure rate was 0.31 (95% CI: 0.18, 0.48) per 10,000 sessions, and 0.71 (95% CI: 0.42, 1.11) per 1000 patients. The Brainsway H-coil seizure rate of 5.56 per 1000 patients (95% CI: 2.77,9.95) was significantly higher (p < 0.001) than the three most widely used figure- 8 coil devices’ combined seizure rate of 0.14 per 1000 patients (95% CI: 0.01, 0.51). Conclusion: The absolute risk of a seizure with rTMS is low, but generic Brainsway H-coil treatment appears to be associated with a higher relative risk than generic figure- 8 coil treatment. Well-designed prospective studies are warranted to further investigate this risk.
KW - Interventional psychiatry
KW - Risk
KW - Safety
KW - Seizure
KW - Transcranial magnetic stimulation
KW - Transcranial Magnetic Stimulation
KW - Prospective Studies
KW - Seizures/epidemiology
KW - Humans
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U2 - 10.1016/j.brs.2021.05.012
DO - 10.1016/j.brs.2021.05.012
M3 - Article
C2 - 34133991
AN - SCOPUS:85108425785
VL - 14
SP - 965
EP - 973
JO - Brain Stimulation
JF - Brain Stimulation
SN - 1935-861X
IS - 4
ER -