Post Marketing Rate of Seizures During Transcranial Magnetic Stimulation (TMS) Treatment with NeuroStar Advanced Therapy Is Lower Than Previously Estimated

Abstract

Background: Published reviews and surveys of incident rate of seizures with any TMS device (Wasserman et al. 1998, Rossi et al. 2009, and Lerner 2019) revealed that the rate ranges from 0.003-0.043%. Many subjects that developed seizures during TMS were treated with parameters outside those recommended in TMS guidelines or were predisposed due to seizure threshold-lowering factors, e.g., concurrent use of certain medications or alcohol, sleep deprivation. Additionally, some non-epileptic events may have been misreported. The objective of this research is to determine the rate of seizures reported to Neuronetics, Inc. relative to treatment sessions and review the number of seizures reported in literature naming this device as the means of TMS delivery. Design/Methods: 1. We conducted a review of TMS literature published after Wasserman (1998) and Rossi (2009) that mentioned seizures and that named this system as the device used for TMS treatment through June 30, 2019. These are captured as part of Neuronetics’ post marketing surveillance procedure. We also reviewed articles that identified this device as that used to deliver TMS treatment. Articles that referenced single-pulse TMS and those that reported seizures during TMS treatment delivered to subjects with epilepsy were excluded. 2. We reviewed all seizure events reported to Neuronetics, Inc., directly or through FDA MedWatch, from time of FDA clearance through June 30, 2019. 3. Seizure incidences reported from antidepressant medication trials were reviewed for comparison. Results: The post marketing surveillance seizure rate with this system is 0.001%, or approximately 1 in 89,000 TMS treatments. Our literature review revealed that no seizures have been reported in articles that identified this system as the TMS system used. Additionally, this system was not named in any articles that reported seizures and identified the TMS system used. Conclusions: The rate of seizures reported for individuals receiving TMS with this system (0.001%) is generally lower than the rates reported in clinical trials for widely used antidepressant medications (0.1% to 0.4%).