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DOI 10.34014/2227-1848-2019-1-26-37

 

SAFETY AND TOLERABILITY OF DIFFERENT PROTOCOLS OF HIGH-FREQUENCY RHYTHMIC TRANSCRANIAL MAGNETIC STIMULATION

 

I.S. Bakulin1, A.G. Poydasheva1, D.Yu. Lagoda1, K.M. Evdokimov2, A.Kh. Zabirova2, N.A. Suponeva1, M.A. Piradov1

1 Research Center of Neurology, Moscow, Russia;

2 Moscow State University named after M.V. Lomonosov, Moscow, Russia

e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Rhythmic transcranial magnetic stimulation (rTMS) is a non-invasive method for brain stimulation, widely used in the treatment of various diseases and in research. In this regard, the problems of rTMS safety and tolerability are becoming especially relevant. Most studies describe only serious side effects of rTMS, which, in fact, are extremely rare. Other side effects which affect rTMS tolerability have been studied to a much lesser extent.

The objective of the study is to examine all side effects which occur during and after rTMS sessions through prospective open observation of patients and healthy volunteers.

Materials and Methods. Using standardized questionnaires, the authors analyzed the incidence of side effects during high-frequency rTMS and within 24 hours after the procedure in 51 patients with various diseases of the nervous system and in 11 healthy volunteers.

Results. The overall frequency of side effects was 59.5 % during stimulation and 50.2 % within 24 hours after the procedure. Serious side effects, which led to cessation of stimulation were recorded in 5 % of cases (n=3). They were associated with the syncope development (n=1) and severe headache (n=2). During rTMS, the most frequent manifestations of side effects were drowsiness (30.4 %), headache (25.8 %) and facial muscle contraction (14.7 %). Twenty-four hours after rTMS the most common manifestations were headache (15.7 %), mood changes (10.2 %) and mental alertness problems (9.4 %). It was found out, that headache was statistically more frequent at the beginning of the rTMS course. During rTMS, headache is often not so heavy and it is usually throbbing. However, within 24 hours after stimulation headache is usually moderate, pressing or dull.

Conclusion. The obtained data confirm the importance of using standardized questionnaires for studying side effects and developing methods for their prevention and relief.

Keywords: transcranial magnetic stimulation, non-invasive brain stimulation, safety, tolerance, side effects, headache, syncope.

 

References

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2. Di Lazzaro V. Biological effects of non-invasive brain stimulation. Handb. Clin. Neurol. 2013; 116: 367–374.

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5. Chung C.L., Mak M.K. Effect of Repetitive Transcranial Magnetic Stimulation on Physical Function and Motor Signs in Parkinson's Disease: A Systematic Review and Meta-Analysis. Brain Stimul. 2016; 9 (4): 475–487.

6. Wang J., Zhou Y., Gan H., Pang J., Li H., Wang J., Li C. Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. Shanghai Arch. Psychiatry. 2017; 29 (2): 61–76.

7. Li Y., Qu Y., Yuan M., Du T. Low-frequency repetitive transcranial magnetic stimulation for patients with aphasia after stoke: A meta-analysis. J. Rehabil. Med. 2015; 47 (8): 675–681.

8. Soleimani R., Jalali M.M., Hasandokht T. Therapeutic impact of repetitive transcranial magnetic stimulation (rTMS) on tinnitus: a systematic review and meta-analysis. Eur. Arch. Otorhinolaryngol. 2016; 273 (7): 1663–1675.

9. Knijnik L.M., Dussan-Sarria J.A., Rozisky J.R., Torres I.L., Brunoni A.R., Fregni F., Caumo W. Repetitive Transcranial Magnetic Stimulation for Fibromyalgia: Systematic Review and Meta-Analysis. Pain Pract. 2016; 16 (3): 294–304.

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12. Rossi S., Hallett M., Rossini P.M., Pascual-Leone A. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin. Neurophysiol. 2009; 120 (12): 2008–2039.

13. Perera T., George M.S., Grammer G., Janicak P.G., Pascual-Leone A., Wirecki T.S. The Clinical TMS Society Consensus Review and Treatment Recommendations for TMS Therapy for Major Depressive Disorder. Brain Stimul. 2016; 9 (3): 336–346.

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15. Wassermann E.M. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5–7, 1996. Electroencephalogr. Clin. Neurophysiol. 1998; 108 (1): 1–16.

16. Gillick B.T., Rich T., Chen M., Meekins G.D. Case report of vasovagal syncope associated with single pulse transcranial magnetic stimulation in a healthy adult participant. BMC Neurol. 2015; 15: 248.

17. Hadar A.A., Makris S., Yarrow K. Single-pulse TMS related syncopal spell in a healthy subject. Brain Stimul. 2012; 5 (4): 652–653.

18. Machii K., Cohen D., Ramos-Estebanez C., Pascual-Leone A. Safety of rTMS to non-motor cortical areas in healthy participants and patients. Clin. Neurophysiol. 2006; 117 (2): 455–471.

19. Kesar T.M., McDonald H.S., Eicholtz S.P., Borich M.R. Case Report of Syncope During a Single Pulse Transcranial Magnetic Stimulation Experiment in a Healthy Adult Participant. Brain Stimul. 2016; 9 (3): 471–472.

20. Makovac E., Thayer J.F., Ottaviani C. A meta-analysis of non-invasive brain stimulation and autonomic functioning: Implications for brain-heart pathways to cardiovascular disease. Neurosci. Biobehav. Rev. 2017; 74 (Pt B): 330–341.

21. Yozbatiran N., Alonso-Alonso M., See J., Demirtas-Tatlidede A., Luu D., Motiwala R.R., Pascual-Leone A., Cramer S.C. Safety and behavioral effects of high-frequency repetitive transcranial magnetic stimulation in stroke. Stroke. 2009; 40 (1): 309–312.

22. Vernieri F., Maggio P., Tibuzzi F., Filippi M.M., Pasqualetti P., Melgari J.M., Altamura C., Palazzo P., Di Giorgio M., Rossini P.M. High frequency repetitive transcranial magnetic stimulation decreases cerebral vasomotor reactivity. Clin. Neurophysiol. 2009; 120 (6): 1188–1194.

23. Vernieri F., Altamura C., Palazzo P., Altavilla R., Fabrizio E., Fini R., Melgari J.M., Paolucci M., Pasqualetti P., Maggio P. 1-Hz repetitive transcranial magnetic stimulation increases cerebral vasomotor reactivity: a possible autonomic nervous system modulation. Brain Stimul. 2014; 7 (2): 281–286.

24. Maizey L., Allen C.P., Dervinis M., Verbruggen F., Varnava A., Kozlov M., Adams R.C., Stokes M., Klemen J., Bungert A., Hounsell C.A., Chambers C.D. Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. Clin. Neurophysiol. 2013; 124 (3): 536–544.

25. Anderson B.S., Kavanagh K., Borckardt J.J., Nahas Z.H., Kose S., Lisanby S.H., McDonald W.M., Avery D., Sackeim H.A., George M.S. Decreasing procedural pain over time of left prefrontal rTMS for depression: initial results from the open-label phase of a multi-site trial (OPT-TMS). Brain Stimul. 2009; 2 (2): 88–92.

26. Loo C.K., McFarquhar T.F., Mitchell P.B. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int. J. Neuropsychopharmacol. 2008; 11 (1): 131–147.

27. Galletly C., Gill S., Rigby A., Carnell B.L., Clarke P. Assessing the Effects of Repetitive Transcranial Magnetic Stimulation on Cognition in Major Depressive Disorder Using Computerized Cognitive Testing. J. ECT. 2016; 32 (3): 169–173.

28. Lage C., Wiles K., Shergill S.S., Tracy D.K. A systematic review of the effects of low-frequency repetitive transcranial magnetic stimulation on cognition. J. Neural. Transm. (Vienna). 2016; 123 (12): 1479–1490.

29. Remue J., Baeken C., De Raedt R. Does a single neurostimulation session really affect mood in healthy individuals? A systematic review. Neuropsychologia. 2016; 85: 184–198.

 

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DOI 10.34014/2227-1848-2019-1-26-37

УДК 616-08-06

 

БЕЗОПАСНОСТЬ И ПЕРЕНОСИМОСТЬ РАЗЛИЧНЫХ ПРОТОКОЛОВ ВЫСОКОЧАСТОТНОЙ РИТМИЧЕСКОЙ ТРАНСКРАНИАЛЬНОЙ МАГНИТНОЙ СТИМУЛЯЦИИ

 

И.С. Бакулин1, А.Г. Пойдашева1, Д.Ю. Лагода1, К.М. Евдокимов2, А.Х. Забирова2, Н.А. Супонева1, М.А. Пирадов1

1 ФГБНУ «Научный центр неврологии», г. Москва, Россия;

2 ФГБОУ ВО «Московский государственный университет им. М.В. Ломоносова»,
г. Москва, Россия

e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Ритмическая транскраниальная магнитная стимуляция (рТМС) является методом неинвазивной стимуляции головного мозга, широко применяемым в терапии различных заболеваний и при проведении фундаментальных научных исследований. В связи с этим особенно актуальными становятся вопросы безопасности и переносимости рТМС. В большинстве исследований описываются только серьезные нежелательные эффекты (НЭ) рТМС, встречающиеся крайне редко. Другие НЭ, влияющие на переносимость рТМС, изучены в значительно меньшей степени.

Цель. Детальное изучение спектра НЭ, возникающих во время и после сеансов рТМС, в ходе проспективного открытого наблюдения за пациентами и здоровыми добровольцами.

Материалы и методы. С помощью стандартизированных опросников проанализирована частота возникновения НЭ во время высокочастотной рТМС и в течение 24 ч после процедуры у 51 пациента с различными заболеваниями нервной системы и 11 здоровых добровольцев.

Результаты. Общая частота НЭ составила 59,5 % во время стимуляции и 50,2 % в течение 24 ч после процедуры. Серьезные НЭ, приводящие к прекращению стимуляции, зарегистрированы в 5 % случаев (n=3) и были связаны с развитием синкопального состояния (n=1) и выраженной головной боли (ГБ) (n=2). Во время рТМС наиболее частыми НЭ явились сонливость (30,4 %), ГБ (25,8 %) и сокращение мышц лица (14,7 %), в течение 24 ч после рТМС – ГБ (15,7 %), изменения настроения (10,2 %) и трудности концентрации внимания (9,4 %). Показано, что ГБ статистически значимо чаще возникает в начале курса рТМС. Во время рТМС ГБ чаще всего имеет низкую интенсивность и пульсирующий характер, в то время как в течение 24 ч после стимуляции в большинстве случаев отмечается умеренная по интенсивности давящая или тупая ГБ.

Выводы. Полученные данные подтверждают важность использования стандартизированных опросников для изучения НЭ и разработки способов их предотвращения и купирования.

Ключевые слова: транскраниальная магнитная стимуляция, неинвазивная стимуляция мозга, безопасность, переносимость, нежелательные эффекты, головная боль, синкопальное состояние.

 

Литература

1. Kobayashi M., Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003; 2 (3): 145–156.

2. Di Lazzaro V. Biological effects of non-invasive brain stimulation. Handb. Clin. Neurol. 2013; 116: 367–374.

3. Rossini P.M., Burke D., Chen R., Cohen L.G., Daskalakis Z., Di Iorio R., Di Lazzaro V., Ferreri F., Fitzgerald P.B., George M.S., Hallett M., Lefaucheur J.P., Langguth B., Matsumoto H., Miniussi C., Nitsche M.A., Pascual-Leone A., Paulus W., Rossi S., Rothwell J.C., Siebner H.R., Ugawa Y., Walsh V., Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin. Neurophysiol. 2015; 126 (6): 1071–1107.

4. Lefaucheur J.P., Andre-Obadia N., Antal A., Ayache S.S., Baeken C., Benninger D.H., Cantello R.M., Cincotta M., de Carvalho M., De Ridder D., Devanne H., Di Lazzaro V., Filipovic S.R., Hummel F.C., Jaaskelainen S.K., Kimiskidis V.K., Koch G., Langguth B., Nyffeler T., Oliviero A., Padberg F., Poulet E., Rossi S., Rossini P.M., Rothwell J.C., Schonfeldt-Lecuona C., Siebner H.R., Slotema C.W., Stagg C.J., Valls-Sole J., Ziemann U., Paulus W., Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin. Neurophysiol. 2014; 125 (11): 2150–2206.

5. Chung C.L., Mak M.K. Effect of Repetitive Transcranial Magnetic Stimulation on Physical Function and Motor Signs in Parkinson's Disease: A Systematic Review and Meta-Analysis. Brain Stimul. 2016; 9 (4): 475–487.

6. Wang J., Zhou Y., Gan H., Pang J., Li H., Wang J., Li C. Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. Shanghai Arch. Psychiatry. 2017; 29 (2): 61–76.

7. Li Y., Qu Y., Yuan M., Du T. Low-frequency repetitive transcranial magnetic stimulation for patients with aphasia after stoke: A meta-analysis. J. Rehabil. Med. 2015; 47 (8): 675–681.

8. Soleimani R., Jalali M.M., Hasandokht T. Therapeutic impact of repetitive transcranial magnetic stimulation (rTMS) on tinnitus: a systematic review and meta-analysis. Eur. Arch. Otorhinolaryngol. 2016; 273 (7): 1663–1675.

9. Knijnik L.M., Dussan-Sarria J.A., Rozisky J.R., Torres I.L., Brunoni A.R., Fregni F., Caumo W. Repetitive Transcranial Magnetic Stimulation for Fibromyalgia: Systematic Review and Meta-Analysis. Pain Pract. 2016; 16 (3): 294–304.

10. Червяков А.В., Пойдашева А.Г., Назарова М.А., Гнездицкий В.В., Супонева Н.А., Черникова Л.А., Пирадов М.А. Навигационная ритмическая транскраниальная магнитная стимуляция в постинсультной реабилитации: рандомизированное слепое плацебо-контролируемое исследование. Анналы клинической и экспериментальной неврологии. 2015; 9 (4): 49–56.

11. Добрушина О.Р., Сидякина И.В., Лядов К.В., Шаповаленко Т.В., Синицын В.Е., Мершина Е.А., Печенкова Е.В., Казымаев С.А., Румшиская А.Д. Навигационная транскраниальная магнитная стимуляция в реабилитации травматического повреждения лобных долей головного мозга. Анналы клинической и экспериментальной неврологии. 2014; 8 (3): 30–36.

12. Rossi S., Hallett M., Rossini P.M., Pascual-Leone A. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin. Neurophysiol. 2009; 120 (12): 2008–2039.

13. Perera T., George M.S., Grammer G., Janicak P.G., Pascual-Leone A., Wirecki T.S. The Clinical TMS Society Consensus Review and Treatment Recommendations for TMS Therapy for Major Depressive Disorder. Brain Stimul. 2016; 9 (3): 336–346.

14. Супонева Н.А., Бакулин И.С., Пойдашева А.Г., Пирадов М.А. Безопасность транскраниальной магнитной стимуляции: обзор международных рекомендаций и новые данные. Нервно-мышечные болезни. 2017; 7 (2): 21–36.

15. Wassermann E.M. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5–7, 1996. Electroencephalogr. Clin. Neurophysiol. 1998; 108 (1): 1–16.

16. Gillick B.T., Rich T., Chen M., Meekins G.D. Case report of vasovagal syncope associated with single pulse transcranial magnetic stimulation in a healthy adult participant. BMC Neurol. 2015; 15: 248.

17. Hadar A.A., Makris S., Yarrow K. Single-pulse TMS related syncopal spell in a healthy subject. Brain Stimul. 2012; 5 (4): 652–653.

18. Machii K., Cohen D., Ramos-Estebanez C., Pascual-Leone A. Safety of rTMS to non-motor cortical areas in healthy participants and patients. Clin. Neurophysiol. 2006; 117 (2): 455–471.

19. Kesar T.M., McDonald H.S., Eicholtz S.P., Borich M.R. Case Report of Syncope During a Single Pulse Transcranial Magnetic Stimulation Experiment in a Healthy Adult Participant. Brain Stimul. 2016; 9 (3): 471–472.

20. Makovac E., Thayer J.F., Ottaviani C. A meta-analysis of non-invasive brain stimulation and autonomic functioning: Implications for brain-heart pathways to cardiovascular disease. Neurosci. Biobehav. Rev. 2017; 74 (Pt B): 330–341.

21. Yozbatiran N., Alonso-Alonso M., See J., Demirtas-Tatlidede A., Luu D., Motiwala R.R., Pascual-Leone A., Cramer S.C. Safety and behavioral effects of high-frequency repetitive transcranial magnetic stimulation in stroke. Stroke. 2009; 40 (1): 309–312.

22. Vernieri F., Maggio P., Tibuzzi F., Filippi M.M., Pasqualetti P., Melgari J.M., Altamura C., Palazzo P., Di Giorgio M., Rossini P.M. High frequency repetitive transcranial magnetic stimulation decreases cerebral vasomotor reactivity. Clin. Neurophysiol. 2009; 120 (6): 1188–1194.

23. Vernieri F., Altamura C., Palazzo P., Altavilla R., Fabrizio E., Fini R., Melgari J.M., Paolucci M., Pasqualetti P., Maggio P. 1-Hz repetitive transcranial magnetic stimulation increases cerebral vasomotor reactivity: a possible autonomic nervous system modulation. Brain Stimul. 2014; 7 (2): 281–286.

24. Maizey L., Allen C.P., Dervinis M., Verbruggen F., Varnava A., Kozlov M., Adams R.C., Stokes M., Klemen J., Bungert A., Hounsell C.A., Chambers C.D. Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. Clin. Neurophysiol. 2013; 124 (3): 536–544.

25. Anderson B.S., Kavanagh K., Borckardt J.J., Nahas Z.H., Kose S., Lisanby S.H., McDonald W.M., Avery D., Sackeim H.A., George M.S. Decreasing procedural pain over time of left prefrontal rTMS for depression: initial results from the open-label phase of a multi-site trial (OPT-TMS). Brain Stimul. 2009; 2 (2): 88–92.

26. Loo C.K., McFarquhar T.F., Mitchell P.B. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int. J. Neuropsychopharmacol. 2008; 11 (1): 131–147.

27. Galletly C., Gill S., Rigby A., Carnell B.L., Clarke P. Assessing the Effects of Repetitive Transcranial Magnetic Stimulation on Cognition in Major Depressive Disorder Using Computerized Cognitive Testing. J. ECT. 2016; 32 (3): 169–173.

28. Lage C., Wiles K., Shergill S.S., Tracy D.K. A systematic review of the effects of low-frequency repetitive transcranial magnetic stimulation on cognition. J. Neural. Transm. (Vienna). 2016; 123 (12): 1479–1490.

29. Remue J., Baeken C., De Raedt R. Does a single neurostimulation session really affect mood in healthy individuals? A systematic review. Neuropsychologia. 2016; 85: 184–198.