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Year 2023, Volume: 5 Issue: 1, 53 - 68, 30.06.2023

Lütfü Hanoğlu Beyzanur Kaç Mahmut Tokaç

https://doi.org/10.52675/jhesp.1279591

Abstract

References

  • Aktürk, T., de Graaf, T.A., Güntekin, B., Hanoğlu, L., Sack, A.T. (2022) Enhancing memory capacity by experimentally slowing theta frequency oscillations using combined EEG- tACS . Scientific Reports, 12,14199.
  • Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Hummel, F.C., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W. (2017). Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clinical Neurophysiology, 128,1774-1809.
  • Baeken, C., Arns, M., Brunelin, J., Chanes, L., Filipcic, I., Ganho -Ávila, A., Hirnstein, M., Rachid, F., Sack, A.T., O'shea, J., D'urso, G., Antal, A. (2023). European reclassification of non-invasive brain stimulation as class III medical devices: A call to action. Brain Stimulation, 16,564-566.
  • Berlim, M.T., Van Den Eynde, F., Jeff Daskalakis, Z. (2013). Clinically meaningful efficacy and acceptability of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) for treating primary major depression: A meta-analysis of randomized, double-blind and sham-controlled trials. Neuropsychopharmacology, 38, 543–551.
  • Brunoni, A.R., Amadera, J., Berbel, B., Volz, M.S., Rizzerio, B.G., Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacol, 1133-1145.
  • Brunoni, A.R., Moffa, A.H., Fregni, F., Palm, U., Padberg, F., Blumberger, D.M., Daskalakis, Z.J., Bennabi, D., Haffen, E., Alonzo, A., Loo, C.K. ( 2016). Transcranial direct current stimulation for acute major depressive episodes: Meta-analysis of individual patient data. The British Journal of Psychiatry, 208, 522–531.
  • Budak, M., Kardes, F.G., Hanoglu, L. (2018). Neural plasticity and neuromodulation applications. Turkey Clinics Physiotherapy and Rehabilitation-Special Topics, 4.79–88.
  • Coffman, B.A., Clark, V.P., Parasuraman, R. (2014). Battery powered thought: Enhancement of attention, learning, and memory in healthy adults using transcranial direct current stimulation. NeuroImage , 85,895–908.
  • Chou, Y.H., Ton That, V., Sundman, M. (2020). A systematic review and meta-analysis of rTMS effects on cognitive enhancement in mild cognitive impairment and Alzheimer's disease. Neurobiology of Aging, 86.1-10.
  • DaSilva, A.F., Datta , A., Swami, J., Kim, DJ, Patil, P.G., Bikson, M. (2022). The concept, development, and application of a home-based high-definition tDCS for bilateral motor cortex modulation in migraine and pain. Frontiers Pain Research (Lausanne), 3.798056.
  • Davis, S.E., Smith, G.A. (2019). Transcranial direct current stimulation use in warfighting: Benefits, risks, and future prospects. Frontiers in Human Neuroscience, 13,114.
  • Dedoncker, J., Brunoni, A.R., Baeken, C., Vanderhasselt, M.A. (2016). A systematic review and meta-analysis of the effects of transcranial direct current stimulation ( tDCS ) over the dorsolateral prefrontal cortex in healthy and neuropsychiatric samples: Influence of stimulation parameters. Brain Stimulation, 9, 501–517.
  • Demirci, S., Hanoğlu, L. (2014). The effects of network theory and transcranial brain stimulation methods on brain networks. Haseki Medical Bulletin, 52,238–47.
  • Dougall, N., Maayan, N., Soares-Weiser, K., Mcdermott, L.M. and Mcintosh, A. (2015). Transcranial magnetic stimulation (TMS) for schizophrenia. Cochrane Database of Systematic Reviews, 8.
  • Dundar-Coecke, S. (2021). Neuromodulation: Looking into the future from the intersection of education and neuroscience. Turkish Journal of Educational Sciences (TEBD), 19, 542-567.
  • European Commission (EU). (2022). Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose ( Text with EEA relevance). Off J Euro Union. L:311-94.
  • European Commission (EU). (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ). Off j Euro Union. L:117-1.
  • European Society for Brain Stimulation. (2023.). Manifesto: Subject: Opposition to EU reclassification of TMS and tDCS equipment to Class III devices based on flawed evidence. Access: https://www.brain-stimulation.eu/manifesto-eu-reclassification-of-nibs/
  • European Union, European Commission. (2021). Better regulation guidelines. Access Address : https://commission.europa.eu/system/files/2021-11/swd2021_305_en.pdf
  • European Union, Medical Device Coordination Group. (2021). MDCG 2021–24 Guidance on classification of medical devices. EU Medical Device Coordination Group.
  • Farzan, F., Vernet, M., Shafi, M.M.D., Rotenberg, A., Daskalakis , Z.J., Pascual-Leone, A. (2016). Characterizing and modulating brain circuitry through transcranial magnetic stimulation combined with electroencephalography. Frontiers in Neural Circuits, 10(SEP). https://doi.org/10.3389/fncir.2016.00073
  • FDA. (2018). Permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder | https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-transcranial-magnetic-stimulation-treatment-obsessive-compulsive-disorder
  • Fregni, F., El- Hagrassy, M.M., Pacheco-Barrios, K., Carvalho, S., Leite, J., Simis, M., Brunelin, J., Nakamura-Palacios, E.M., Marangolo, P., Venkatasubramanian, G., San-Juan, D., Caumo, W., Bikson, M., Brunoni, A.R., Neuromodulation Center Working Group. (2021). Evidence based guidelines and secondary meta-analysis for the use of direct current stimulation- in psychiatric disorders. International Journal of Neuropsychopharmacology, 24, 256-313.
  • Hanoglu, L., Koleksiyontas, E., Saricaoglu, M., Velioglu, H.A., Yıldız, S., Yulug, B. (2022). Therapeutic role of repetitive transcranial magnetic stimulation in alzheimer's and parkinson's disease: Electroencephalography microstate correlates. Frontiers in Neuroscience, 16,798558.
  • Hanoglu, L., Velioglu, H.A., Hanoglu, T., Yulug, B. (2021). Neuroimaging-guided transcranial magnetic and direct current stimulation in MCI: Toward an individual, effective and disease-modifying treatment. Clinical EEG Neuroscience, 9.
  • Lefaucheur, J.P., Aleman, A., Baeken, C., Benninger, D.H., Brunelin, J., Di Lazzaro, V., Filipović, S.R., Grefkes, C., Hasan, A., Hummel, F.C., Jääskeläinen, S.K. , Langguth, B., Leocani, L., Londero, A., Nardone, R., Nguyen, J.P., Nyffeler, T., Oliveira-Maia, A.J., Oliviero, A., Padberg, F., Palm, U., Paulus, W., Poulet, E., Quartarone, A., Rachid, F., Rektorová, I., Rossi, S., Sahlsten, H., Schecklmann, M., Szekely, D., Ziemann, U. (2020). Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation ( rTMS ): An update (2014-2018). Erratum in: Clinical Neurophysiology, 131,1168-1169.
  • Lefaucheur, J.P., André- 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., Filipović, S.R., Hummel, F.C., Jääskeläinen, S.K., Kimiskidis, V.K., Koch, G., Langguth, B., Nyffeler, T., Garcia- Larrea, L. ( 2014). Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation ( rTMS ). Clinical Neurophysiology, 125, 2150–2206.
  • Li, H., Wang, J., Li, C., and Xiao, Z. (2014). Repetitive transcranial magnetic stimulation ( rTMS ) for panic disorder in adults. Cochrane Database of Systematic Reviews, (9).
  • Liu, Y., Gu, N., Cao, X., Zhu, Y., Wang, J., Smith, RC, Li, C. (2021). Effects of transcranial electrical stimulation on working memory in patients with schizophrenia: A systematic review and meta-analysis. Psychiatry Research, 296, 113656.
  • Moffa, A.H., Martin, D., Alonzo, A., Bennabi, D., Blumberger, D.M., Benseñor, I.M., Daskalakis, Z., Fregni, F., Haffen, E., Lisanby, SH, Padberg, F., Palm, U., Razza , L.B., Sampaio-Jr, B., Loo, C., Brunoni, A.R. (2020). Efficacy and acceptability of transcranial direct current stimulation ( tDCS ) for major depressive disorder: An individual patient data meta-analysis. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 99, 109836.
  • Mutz, J., Vipulananthan, V., Carter, B., Hurlemann, R., Fu, C.H.Y., Young, A.H. (2019). Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ (Online), 364.
  • Onarheim, Balder. (2023). EU regulators grossly misrepresent non-invasive brain stimulation. Access Address : https://neuromodec.org/2023/01/eu-regulators-grossly-misrepresent-non-invasive-brain-stimulation/
  • Paulus, W. (2011). Transcranial electrical stimulation ( tES - tDCS ; tRNS , tACS ) methods. Neuropsychological Rehabilitation, 21, 602–617.
  • Pereira, L.S., Müller, V.T., Mota Gomes, M., Rotenberg, A., Fregni, F. (2016). Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review. Epilepsy and Behavior, 57, 167–176.
  • Polat, B., Hanoglu, L. (2021). Neuromodulation methods tried in dementia. GG Yener, O. Yılmaz Kübeci (ed.). Alzheimer's Disease (158-168. pp.). Ankara; Türkiye Clinics.
  • Rossi, S., Antal, A., Bestmann, S., Bikson, M., Brewer, C., Brockmöller, J., Carpenter, LL, Cincotta, M., Chen, R., Daskalakis, J.D., Di Lazzaro, V., Fox, MD, George, MS, Gilbert, D., Kimiskidis, VK, Koch, G., Ilmoniemi, RJ, Lefaucheur, J.P., Leocani, L., Lisanby, S.H., Miniussi, C., Padberg, F., Pascual-Leone, A., Paulus, W., Peterchev, A.V., Quartarone, A., Rotenberg, A., Rothwell, J., Rossini, P.M., Santarnecchi, E., Shafi, M.M., Siebner, H.R., Ugawa, Y., Wassermann, E.M., Zangen, A., Ziemann, U., Hallett, M. 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. (2021). Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert guidelines. Clinical Neurophysiology, 132,269-306.
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  • Saricaoglu, M., Hanoglu, L., Toprak, G., Yilmaz, N.H., Yulug, B. (2022). The multifactorial role of pre-supplementary motor area stimulation in the freezing of gait: An alternative strategy to the classical drug-target approach. Endocrine, Metabolic and Immune Disorders-Drug Targets, 22,518-524.
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  • Carvalho, JB De, Van De Bilt, M., Lacerda, A.L.T., Elkis, H., Gattaz, W.F., Brunoni, A.R. (2020). Efficacy and safety of transcranial direct current stimulation for treating negative symptoms in schizophrenia: A randomized clinical trial. JAMA Psychiatry, 77, 121–129.
  • Velioglu, H.A., Hanoglu , L., Bayraktaroglu , Z., Toprak , G., Guler, EM, Bektay, M.Y., Mutlu-Burnaz , O., Yulug, B. (2021). Left lateral parietal rTMS improves cognition and modulates resting brain connectivity in patients with Alzheimer's disease: Possible role of BDNF and oxidative stress. Neurobiology of Learning and Memory, 180,107410.
  • Young, L., Camprodon, J.A., Hauser, M., Pascual-Leone, A., Saxe, R. (2010). Disruption of the right temporoparietal junction with transcranial magnetic stimulation reduces the role of beliefs in moral judgments. Proceedings of the National Academy of Sciences of the United States of America, 107(, 6753–6758.

POSSIBLE CONSEQUENCES OF RECLASSIFICATION OF NON-INVASIVE BRAIN STIMULATING AS A CLASS III MEDICAL DEVICES IN EUROPE AND ITS REFLECTIONS TO OUR COUNTRY

Year 2023, Volume: 5 Issue: 1, 53 - 68, 30.06.2023

Lütfü Hanoğlu Beyzanur Kaç Mahmut Tokaç

https://doi.org/10.52675/jhesp.1279591

Abstract

ABSTRACT
Neuromodulation techniques (NIBS) and devices that have emerged in the last thirty years are continued to develop rapidly. NIBS, which initially appeared to be effective only for the treatment of some neurological diseases, has been found to be effective in increase the capacities of normal people for education, sports, business life and military fields over time. This has led to the production of home/individual use versions of NIBS devices. On the one hand, the individual use of these devices is increasing rapidly in many countries, on the other hand, many researches on the effectiveness, safety and new usage areas of the techniques continue. The production, placing on the market and use of all this NIBS devices to be used for scientific research, treatment or individual uses are directly or indirectly dependent on the rules and conditions in the Medical Devices Regulation (MDR) of the European Union (EU). Our country also complies with these rules. A new regulation numbered 2022/2347 has been published by the EU for the specification of non-medical product groups included in the Annex XVI of regulation No. 2017/745. NIBS devices, one of the product groups in question, have been subjected to a new classification due to this regulation and this change has caused various objections from all stakeholders related to this field. Objections to the new classification stem from the fact that ethics committees will drastically change their approach to research in these areas, and that these changes involve much more challenging conditions for researchers and device manufacturers than before. As a result of this situation, the main concern has emerged that the limitation of research will lead to the interruption of production and development activities in this field and even to prevent the the patients, from benefiting from these treatments.
In this study, the old and new regulations are analysed together and it is aimed to evaluate the appropriateness of the procedure and content of the regulation, its reflections on the field and the criticisms brought to the regulation in the light of scientific data in the field. Based on this assessment, an attempt has been made to provide a perspective to the relevant stakeholders in Turkey, researchers, ethics committees that authorise/supervise research with these devices in line with the EU, and the competent authority that oversees the production, distribution and conformity of medical devices, both on the current situation and what should be.
Keywords: Non-invasive neuromodulation, European Union Medical Device Regulation, MDR, Turkish Medicines and Medical Devices Agency (TİTCK)

Keywords

Non-invasive neuromodulation European Union Medical Device Regulation MDR Turkish Medicines and Medical Devices Agency (TİTCK)

References

  • Aktürk, T., de Graaf, T.A., Güntekin, B., Hanoğlu, L., Sack, A.T. (2022) Enhancing memory capacity by experimentally slowing theta frequency oscillations using combined EEG- tACS . Scientific Reports, 12,14199.
  • Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Hummel, F.C., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W. (2017). Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clinical Neurophysiology, 128,1774-1809.
  • Baeken, C., Arns, M., Brunelin, J., Chanes, L., Filipcic, I., Ganho -Ávila, A., Hirnstein, M., Rachid, F., Sack, A.T., O'shea, J., D'urso, G., Antal, A. (2023). European reclassification of non-invasive brain stimulation as class III medical devices: A call to action. Brain Stimulation, 16,564-566.
  • Berlim, M.T., Van Den Eynde, F., Jeff Daskalakis, Z. (2013). Clinically meaningful efficacy and acceptability of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) for treating primary major depression: A meta-analysis of randomized, double-blind and sham-controlled trials. Neuropsychopharmacology, 38, 543–551.
  • Brunoni, A.R., Amadera, J., Berbel, B., Volz, M.S., Rizzerio, B.G., Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacol, 1133-1145.
  • Brunoni, A.R., Moffa, A.H., Fregni, F., Palm, U., Padberg, F., Blumberger, D.M., Daskalakis, Z.J., Bennabi, D., Haffen, E., Alonzo, A., Loo, C.K. ( 2016). Transcranial direct current stimulation for acute major depressive episodes: Meta-analysis of individual patient data. The British Journal of Psychiatry, 208, 522–531.
  • Budak, M., Kardes, F.G., Hanoglu, L. (2018). Neural plasticity and neuromodulation applications. Turkey Clinics Physiotherapy and Rehabilitation-Special Topics, 4.79–88.
  • Coffman, B.A., Clark, V.P., Parasuraman, R. (2014). Battery powered thought: Enhancement of attention, learning, and memory in healthy adults using transcranial direct current stimulation. NeuroImage , 85,895–908.
  • Chou, Y.H., Ton That, V., Sundman, M. (2020). A systematic review and meta-analysis of rTMS effects on cognitive enhancement in mild cognitive impairment and Alzheimer's disease. Neurobiology of Aging, 86.1-10.
  • DaSilva, A.F., Datta , A., Swami, J., Kim, DJ, Patil, P.G., Bikson, M. (2022). The concept, development, and application of a home-based high-definition tDCS for bilateral motor cortex modulation in migraine and pain. Frontiers Pain Research (Lausanne), 3.798056.
  • Davis, S.E., Smith, G.A. (2019). Transcranial direct current stimulation use in warfighting: Benefits, risks, and future prospects. Frontiers in Human Neuroscience, 13,114.
  • Dedoncker, J., Brunoni, A.R., Baeken, C., Vanderhasselt, M.A. (2016). A systematic review and meta-analysis of the effects of transcranial direct current stimulation ( tDCS ) over the dorsolateral prefrontal cortex in healthy and neuropsychiatric samples: Influence of stimulation parameters. Brain Stimulation, 9, 501–517.
  • Demirci, S., Hanoğlu, L. (2014). The effects of network theory and transcranial brain stimulation methods on brain networks. Haseki Medical Bulletin, 52,238–47.
  • Dougall, N., Maayan, N., Soares-Weiser, K., Mcdermott, L.M. and Mcintosh, A. (2015). Transcranial magnetic stimulation (TMS) for schizophrenia. Cochrane Database of Systematic Reviews, 8.
  • Dundar-Coecke, S. (2021). Neuromodulation: Looking into the future from the intersection of education and neuroscience. Turkish Journal of Educational Sciences (TEBD), 19, 542-567.
  • European Commission (EU). (2022). Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose ( Text with EEA relevance). Off J Euro Union. L:311-94.
  • European Commission (EU). (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ). Off j Euro Union. L:117-1.
  • European Society for Brain Stimulation. (2023.). Manifesto: Subject: Opposition to EU reclassification of TMS and tDCS equipment to Class III devices based on flawed evidence. Access: https://www.brain-stimulation.eu/manifesto-eu-reclassification-of-nibs/
  • European Union, European Commission. (2021). Better regulation guidelines. Access Address : https://commission.europa.eu/system/files/2021-11/swd2021_305_en.pdf
  • European Union, Medical Device Coordination Group. (2021). MDCG 2021–24 Guidance on classification of medical devices. EU Medical Device Coordination Group.
  • Farzan, F., Vernet, M., Shafi, M.M.D., Rotenberg, A., Daskalakis , Z.J., Pascual-Leone, A. (2016). Characterizing and modulating brain circuitry through transcranial magnetic stimulation combined with electroencephalography. Frontiers in Neural Circuits, 10(SEP). https://doi.org/10.3389/fncir.2016.00073
  • FDA. (2018). Permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder | https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-transcranial-magnetic-stimulation-treatment-obsessive-compulsive-disorder
  • Fregni, F., El- Hagrassy, M.M., Pacheco-Barrios, K., Carvalho, S., Leite, J., Simis, M., Brunelin, J., Nakamura-Palacios, E.M., Marangolo, P., Venkatasubramanian, G., San-Juan, D., Caumo, W., Bikson, M., Brunoni, A.R., Neuromodulation Center Working Group. (2021). Evidence based guidelines and secondary meta-analysis for the use of direct current stimulation- in psychiatric disorders. International Journal of Neuropsychopharmacology, 24, 256-313.
  • Hanoglu, L., Koleksiyontas, E., Saricaoglu, M., Velioglu, H.A., Yıldız, S., Yulug, B. (2022). Therapeutic role of repetitive transcranial magnetic stimulation in alzheimer's and parkinson's disease: Electroencephalography microstate correlates. Frontiers in Neuroscience, 16,798558.
  • Hanoglu, L., Velioglu, H.A., Hanoglu, T., Yulug, B. (2021). Neuroimaging-guided transcranial magnetic and direct current stimulation in MCI: Toward an individual, effective and disease-modifying treatment. Clinical EEG Neuroscience, 9.
  • Lefaucheur, J.P., Aleman, A., Baeken, C., Benninger, D.H., Brunelin, J., Di Lazzaro, V., Filipović, S.R., Grefkes, C., Hasan, A., Hummel, F.C., Jääskeläinen, S.K. , Langguth, B., Leocani, L., Londero, A., Nardone, R., Nguyen, J.P., Nyffeler, T., Oliveira-Maia, A.J., Oliviero, A., Padberg, F., Palm, U., Paulus, W., Poulet, E., Quartarone, A., Rachid, F., Rektorová, I., Rossi, S., Sahlsten, H., Schecklmann, M., Szekely, D., Ziemann, U. (2020). Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation ( rTMS ): An update (2014-2018). Erratum in: Clinical Neurophysiology, 131,1168-1169.
  • Lefaucheur, J.P., André- 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., Filipović, S.R., Hummel, F.C., Jääskeläinen, S.K., Kimiskidis, V.K., Koch, G., Langguth, B., Nyffeler, T., Garcia- Larrea, L. ( 2014). Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation ( rTMS ). Clinical Neurophysiology, 125, 2150–2206.
  • Li, H., Wang, J., Li, C., and Xiao, Z. (2014). Repetitive transcranial magnetic stimulation ( rTMS ) for panic disorder in adults. Cochrane Database of Systematic Reviews, (9).
  • Liu, Y., Gu, N., Cao, X., Zhu, Y., Wang, J., Smith, RC, Li, C. (2021). Effects of transcranial electrical stimulation on working memory in patients with schizophrenia: A systematic review and meta-analysis. Psychiatry Research, 296, 113656.
  • Moffa, A.H., Martin, D., Alonzo, A., Bennabi, D., Blumberger, D.M., Benseñor, I.M., Daskalakis, Z., Fregni, F., Haffen, E., Lisanby, SH, Padberg, F., Palm, U., Razza , L.B., Sampaio-Jr, B., Loo, C., Brunoni, A.R. (2020). Efficacy and acceptability of transcranial direct current stimulation ( tDCS ) for major depressive disorder: An individual patient data meta-analysis. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 99, 109836.
  • Mutz, J., Vipulananthan, V., Carter, B., Hurlemann, R., Fu, C.H.Y., Young, A.H. (2019). Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ (Online), 364.
  • Onarheim, Balder. (2023). EU regulators grossly misrepresent non-invasive brain stimulation. Access Address : https://neuromodec.org/2023/01/eu-regulators-grossly-misrepresent-non-invasive-brain-stimulation/
  • Paulus, W. (2011). Transcranial electrical stimulation ( tES - tDCS ; tRNS , tACS ) methods. Neuropsychological Rehabilitation, 21, 602–617.
  • Pereira, L.S., Müller, V.T., Mota Gomes, M., Rotenberg, A., Fregni, F. (2016). Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review. Epilepsy and Behavior, 57, 167–176.
  • Polat, B., Hanoglu, L. (2021). Neuromodulation methods tried in dementia. GG Yener, O. Yılmaz Kübeci (ed.). Alzheimer's Disease (158-168. pp.). Ankara; Türkiye Clinics.
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Details

Primary Language English
Subjects Health Care Administration
Journal Section Review Articles
Authors

Lütfü Hanoğlu 0000-0003-4292-5717

Beyzanur Kaç 0000-0002-7461-1942

Mahmut Tokaç 0000-0002-3051-0074

Publication Date June 30, 2023
Published in Issue Year 2023 Volume: 5 Issue: 1

Cite

APA Hanoğlu, L., Kaç, B., & Tokaç, M. (2023). POSSIBLE CONSEQUENCES OF RECLASSIFICATION OF NON-INVASIVE BRAIN STIMULATING AS A CLASS III MEDICAL DEVICES IN EUROPE AND ITS REFLECTIONS TO OUR COUNTRY. Journal of Health Systems and Policies, 5(1), 53-68. https://doi.org/10.52675/jhesp.1279591
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