This chapter examines the regulatory perspectives on transcranial magnetic stimulation (TMS) technology, emphasizing its expanding therapeutic potential and the critical need for comprehensive regulation. Since its initial FDA approval in 2008, TMS has gained recognition for treating psychiatric conditions such as nicotine addiction, anxiety, and depression, yet it has not garnered the same level of public scrutiny as other neurological technologies such as brain–computer interfaces and electro-convulsive therapy. While one of the advantages of TMS includes its non-invasiveness, it is unknown whether the absence of such scrutiny constitutes a blind spot or an informed ambivalence. This document reviews the regulatory history of TMS, highlighting the incremental approvals for different therapeutic uses and the challenges posed by off-label and do-it-yourself (DIY) applications. The analysis also highlights unregulated DIY TMS devices’ safety, efficacy, and ethical concerns. It advocates establishing an independent working group to evaluate and disseminate information on direct-to-consumer and DIY neurotechnology. By comparing regulatory approaches in the USA and Europe, this chapter underscores the disparity in regulatory rigor and the necessity for a unified framework. Recommendations include developing clear guidelines, public outreach campaigns, and interdisciplinary collaboration to enhance regulatory compliance and public safety. The Economic Disincentives Model (EDM) is proposed as a potential regulatory approach to managing enhancement uses of TMS. As advancements in brain modulation continue, this chapter calls for proactive legal and policy reforms to ensure ethical practices and maximize the benefits of TMS technology.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Regulatory Perspectives on Transcranial Magnetic Stimulation

  • Michael Pflanzer,
  • Veljko Dubljević

摘要

This chapter examines the regulatory perspectives on transcranial magnetic stimulation (TMS) technology, emphasizing its expanding therapeutic potential and the critical need for comprehensive regulation. Since its initial FDA approval in 2008, TMS has gained recognition for treating psychiatric conditions such as nicotine addiction, anxiety, and depression, yet it has not garnered the same level of public scrutiny as other neurological technologies such as brain–computer interfaces and electro-convulsive therapy. While one of the advantages of TMS includes its non-invasiveness, it is unknown whether the absence of such scrutiny constitutes a blind spot or an informed ambivalence. This document reviews the regulatory history of TMS, highlighting the incremental approvals for different therapeutic uses and the challenges posed by off-label and do-it-yourself (DIY) applications. The analysis also highlights unregulated DIY TMS devices’ safety, efficacy, and ethical concerns. It advocates establishing an independent working group to evaluate and disseminate information on direct-to-consumer and DIY neurotechnology. By comparing regulatory approaches in the USA and Europe, this chapter underscores the disparity in regulatory rigor and the necessity for a unified framework. Recommendations include developing clear guidelines, public outreach campaigns, and interdisciplinary collaboration to enhance regulatory compliance and public safety. The Economic Disincentives Model (EDM) is proposed as a potential regulatory approach to managing enhancement uses of TMS. As advancements in brain modulation continue, this chapter calls for proactive legal and policy reforms to ensure ethical practices and maximize the benefits of TMS technology.