1c150ad915355629d2de6bbc36a37594 pmc_9094636.pdf 0a990f41c7aeba871c92b9f201299957c4e8f29b pmc_9094636.pdf 439d0ee4a09b07c6c1176445bd1d4ea19fa15c6260bb8a1c655d5f701c0873db pmc_9094636.pdf Title: Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines Keywords: TMS, rTMS, TBS, QPS, Safety, Neuromodulation, Neurology, Psychiatry Author: Simone Rossi, Andrea Antal, Sven Bestmann, Marom Bikson, Carmen Brewer, Jürgen Brockmöller, Linda L. Carpenter, Massimo Cincotta, Robert Chen, Jeff D. Daskalakis, Vincenzo Di Lazzaro, Michael D. Fox, Mark S. George, Donald Gilbert, Vasilios K. Kimiskidis, Giacomo Koch, Risto J. Ilmoniemi, Jean Pascal Lefaucheur, Letizia Leocani, Sarah H. Lisanby, Carlo Miniussi, Frank Padberg, Alvaro Pascual-Leone, Walter Paulus, Angel V. Peterchev, Angelo Quartarone, Alexander Rotenberg, John Rothwell, Paolo M. Rossini, Emiliano Santarnecchi, Mouhsin M. Shafi, Hartwig R. Siebner, Yoshikatzu Ugawa, Eric M. Wassermann, Abraham Zangen, Ulf Ziemann, Mark Hallett, The basis of this article began with a Consensus Statement from the IFCN Workshop on “Present, Future of TMS: Safety, Ethical Guidelines”, Siena, October 17-20, 2018, updating through April 2020 Creator: AH Formatter V7.2 MR3 for Linux64 : 7.2.4.55390 (2022-01-31T09:48+09) Producer: Antenna House PDF Output Library 7.2.1732 CreationDate: Thu May 12 00:49:35 2022 CEST ModDate: Thu May 12 00:49:35 2022 CEST Tagged: yes UserProperties: no Suspects: no Form: none JavaScript: no Pages: 89 Encrypted: no Page size: 612 x 792 pts (letter) Page rot: 0 File size: 630470 bytes Optimized: no PDF version: 1.5 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- Helvetica-Bold Type 1 Custom no no yes 11 0 Helvetica Type 1 Custom no no yes 14 0 Times-Roman Type 1 Custom no no yes 69 0 Times-Bold Type 1 Custom no no yes 465 0 ORYZDG+Code2000 CID TrueType Identity-H yes yes yes 693 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2023-12-02 02:37:55 CET RepresentationInformation: pmc_9094636.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2023-11-04 02:19:36 CET Size: 630470 Format: PDF Version: 1.5 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf Profile: Tagged PDF PDFMetadata: Objects: 0 FreeObjects: 476 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: false CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseOutlines Language: EN Outlines: Item: Title: Abstract Item: Title: Introduction Item: Title: New TMS devices and methods Children: Item: Title: Risk analysis and management Item: Title: Technical safety Item: Title: Stimulation dose safety Item: Title: Experimental/animal models Item: Title: Manufacturer vs user responsibilities Children: Item: Title: Manufacturer responsibilities Item: Title: User responsibilities Item: Title: Brief review of new devices and paradigms Children: Item: Title: New pulse generators and stimulus waveforms Item: Title: New pulse sequences Item: Title: New coils Item: Title: Other paradigms of stimulation (Low field magnetic stimulation; transcranial static magnetic stimulation) Children: Item: Title: Low-field magnetic stimulation Item: Title: Transcranial static magnetic stimulation (tSMS) Item: Title: Role of neuroimaging in improving TMS safety Item: Title: Image-guided frameless navigation and robots for improving TMS safety: an emerging issue Item: Title: Safety in combination with other devices Children: Item: Title: MRI environment Item: Title: Implanted or non-removable intracranial metal or devices Children: Item: Title: Heating Item: Title: Forces and magnetization Item: Title: Induced electrode current Item: Title: Malfunction or damage of electronic implants Item: Title: TMS in patients with implanted stimulating/recording electrodes Item: Title: Conclusions and recommendations Item: Title: tDCS/tACS/tRNS Item: Title: Drugs Item: Title: Adverse effects Children: Item: Title: Seizures Children: Item: Title: Risk factors for TMS-provoked seizures Children: Item: Title: Neuropsychiatric disease. Item: Title: General factors relevant to TMS-provoked seizure. Item: Title: Medical factors relevant to TMS-provoked seizure. Item: Title: The rate of seizures caused by TMS Item: Title: Hearing Children: Item: Title: Recommendations: Item: Title: TMS safety on cognition Children: Item: Title: Cognitive TMS effects in experimental studies Item: Title: Cognitive TMS effects in clinical studies Item: Title: Special issues for children and pregnancy Children: Item: Title: TMS in pediatrics Item: Title: Hearing in pediatrics Item: Title: TMS in pregnancy Item: Title: Magnetic seizure therapy Children: Item: Title: Definition Item: Title: Therapeutic setting and pre-procedure evaluation Item: Title: Dosing Item: Title: Animal testing Item: Title: MST in clinical trials Children: Item: Title: Cognition: Item: Title: Cardiovascular effects and complications from anesthesia: Item: Title: Psychiatric Complications: Item: Title: Other potential complications of ECT, not reported to date with MST: Item: Title: Other potential complications specific to MST: Item: Title: Special Populations   Item: Title: Side effects in specific patient populations Children: Item: Title: Neurology and rehabilitation Item: Title: Alzhemer’s disease and new multi-site stimulation paradigms Item: Title: Psychiatry Item: Title: Update of safety tables Children: Item: Title: Conventional rTMS: low and high frequency Item: Title: Patterned rTMS: Quadripulse stimulation (QPS) Item: Title: Patterned rTMS: theta burst stimulation (TBS) Item: Title: Paired associative stimulation (PAS) protocols Item: Title: Training of operators Children: Item: Title: Requirements for TMS users (summary of IFCN training guidelines) Item: Title: Safety for operators Item: Title: Regulatory issues and ethics (with a note on neuroenhancement) Children: Item: Title: TMS in research or clinical setting Children: Item: Title: Basic, physiological, non-therapeutic research Item: Title: Therapeutic research Item: Title: Therapeutic clinical application Item: Title: Steps to mitigate risk Children: Item: Title: TMS in vulnerable populations Item: Title: Recommendations on minimum safety precautions of different use and settings of TMS Children: Item: Title: Research Setting: Item: Title: Clinical Setting: Item: Title: Limitations of current safety data Item: Title: Registration, standardized documentation and reporting Item: Title: A note on neuroenhancement Item: Title: References Item: Title: Table 1 Filters: FilterPipeline: FlateDecode FilterPipeline: DCTDecode Images: Image: NisoImageMetadata: FormatName: image/jpg CompressionScheme: JPEG ImageWidth: 152 ImageHeight: 152 ColorSpace: RGB BitsPerSample: 8 BitsPerSampleUnit: integer Fonts: Type0: Font: BaseFont: ORYZDG+Code2000 Encoding: Identity-H ToUnicode: true Type1: Font: BaseFont: Times-Bold FirstChar: 32 LastChar: 128 FontDescriptor: FontName: Times-Bold Flags: Nonsymbolic FontBBox: -168, -218, 1000, 935 EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: Times-Roman FirstChar: 32 LastChar: 155 FontDescriptor: FontName: Times-Roman Flags: Nonsymbolic FontBBox: -168, -218, 1000, 898 EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: Helvetica-Bold FirstChar: 32 LastChar: 135 FontDescriptor: FontName: Helvetica-Bold Flags: Nonsymbolic FontBBox: -170, -228, 1003, 962 EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: Helvetica FirstChar: 32 LastChar: 133 FontDescriptor: FontName: Helvetica Flags: Nonsymbolic FontBBox: -166, -225, 1000, 931 EncodingDictionary: Differences: true ToUnicode: true CIDFontType2: Font: BaseFont: ORYZDG+Code2000 CIDSystemInfo: Registry: Adobe Registry: Identity Supplement: 0 FontDescriptor: FontName: ORYZDG+Code2000 Flags: Symbolic FontBBox: -1111, -295, 2107, 977 FontFile2: true XMP: 2022-05-11T17:49:35-05:00 2022-05-11T17:49:35-05:00 application/pdf Antenna House PDF Output Library 7.2.1732 TMS, rTMS, TBS, QPS, Safety, Neuromodulation, Neurology, Psychiatry AH Formatter V7.2 MR3 for Linux64 : 7.2.4.55390 (2022-01-31T09:48+09) 2022-05-11T17:49:35-05:00 Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines Simone Rossi, Andrea Antal, Sven Bestmann, Marom Bikson, Carmen Brewer, Jürgen Brockmöller, Linda L. Carpenter, Massimo Cincotta, Robert Chen, Jeff D. Daskalakis, Vincenzo Di Lazzaro, Michael D. Fox, Mark S. George, Donald Gilbert, Vasilios K. Kimiskidis, Giacomo Koch, Risto J. Ilmoniemi, Jean Pascal Lefaucheur, Letizia Leocani, Sarah H. Lisanby, Carlo Miniussi, Frank Padberg, Alvaro Pascual-Leone, Walter Paulus, Angel V. Peterchev, Angelo Quartarone, Alexander Rotenberg, John Rothwell, Paolo M. Rossini, Emiliano Santarnecchi, Mouhsin M. Shafi, Hartwig R. Siebner, Yoshikatzu Ugawa, Eric M. Wassermann, Abraham Zangen, Ulf Ziemann, Mark Hallett, The basis of this article began with a Consensus Statement from the IFCN Workshop on “Present, Future of TMS: Safety, Ethical Guidelines”, Siena, October 17-20, 2018, updating through April 2020 TMSrTMSTBSQPSSafetyNeuromodulationNeurologyPsychiatry Pages: Page: Sequence: 1 Annotations: Annotation: Subtype: Link Contents: http://creativecommons.org/licenses/by-nc-nd/4.0/ Rect: 296, 155, 457, 163 LastModified: D:20220511174935-05'00' Annotation: Subtype: Link Contents: https://doi.org/10.1016/j.clinph.2020.10.003 Rect: 272, 72, 414, 80 LastModified: D:20220511174935-05'00' Page: Sequence: 2 Page: Sequence: 3 Page: Sequence: 4 Page: Sequence: 5 Page: Sequence: 6 Page: Sequence: 7 Page: Sequence: 8 Page: Sequence: 9 Page: Sequence: 10 Page: Sequence: 11 Page: Sequence: 12 Page: Sequence: 13 Page: Sequence: 14 Page: Sequence: 15 Page: Sequence: 16 Page: Sequence: 17 Page: Sequence: 18 Page: Sequence: 19 Page: Sequence: 20 Page: Sequence: 21 Page: Sequence: 22 Page: Sequence: 23 Page: Sequence: 24 Page: Sequence: 25 Page: Sequence: 26 Page: Sequence: 27 Page: Sequence: 28 Page: Sequence: 29 Page: Sequence: 30 Page: Sequence: 31 Page: Sequence: 32 Page: Sequence: 33 Page: Sequence: 34 Page: Sequence: 35 Page: Sequence: 36 Page: Sequence: 37 Page: Sequence: 38 Page: Sequence: 39 Page: Sequence: 40 Page: Sequence: 41 Page: Sequence: 42 Page: Sequence: 43 Page: Sequence: 44 Page: Sequence: 45 Page: Sequence: 46 Page: Sequence: 47 Page: Sequence: 48 Page: Sequence: 49 Page: Sequence: 50 Page: Sequence: 51 Page: Sequence: 52 Page: Sequence: 53 Page: Sequence: 54 Page: Sequence: 55 Page: Sequence: 56 Page: Sequence: 57 Page: Sequence: 58 Page: Sequence: 59 Page: Sequence: 60 Page: Sequence: 61 Page: Sequence: 62 Page: Sequence: 63 Page: Sequence: 64 Page: Sequence: 65 Page: Sequence: 66 Page: Sequence: 67 Page: Sequence: 68 Page: Sequence: 69 Page: Sequence: 70 Page: Sequence: 71 Page: Sequence: 72 Page: Sequence: 73 Page: Sequence: 74 Page: Sequence: 75 Page: Sequence: 76 Page: Sequence: 77 Page: Sequence: 78 Page: Sequence: 79 Page: Sequence: 80 Page: Sequence: 81 Page: Sequence: 82 Page: Sequence: 83 Page: Sequence: 84 Page: Sequence: 85 Page: Sequence: 86 Page: Sequence: 87 Page: Sequence: 88 Page: Sequence: 89 Checksum: d3798a2a Type: CRC32 Checksum: 1c150ad915355629d2de6bbc36a37594 Type: MD5 Checksum: 0a990f41c7aeba871c92b9f201299957c4e8f29b Type: SHA-1 Checksum: 439d0ee4a09b07c6c1176445bd1d4ea19fa15c6260bb8a1c655d5f701c0873db Type: SHA-256