TMS FDA Approved Indications

Release time :2022-10-21

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1.Definition

Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulation technology. The time-varying pulsed magnetic field can penetrate the skull non-invasively, act on the central nervous system, generate induced currents, and cause a series of physiological and biochemical reactions, thus affecting brain metabolism and neuronal excitability, so as to improve and treat mental and neurological diseases.

TMS mainly achieves the function of excitation or inhibition of the local cerebral cortex by changing the stimulation frequency, and treats diseases by bidirectionally regulating the balance between the excitation and inhibition functions of the brain.

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2.Features

①Non-invasive;②Painless;③Safe, with little side effects;④Reliable efficacy;⑤It can be used for clinical detection and clinical treatment.

3.TMS FDA Approved Indications

  • In 2008, FDA approved TMS for the treatment of major depression;
  • In 2013, FDA approved TMS for the treatment of migraine;
  • In 2020, FDA approved TMS for the treatment of obsessive-compulsive disorder (OCD);
  • In 2021, FDA approved TMS for the treatment of depression with anxiety symptoms.

4.Other Approvals of TMS Technology

4.1Clinical guidelines

  • In 2014, the International Federation of Clinical Neurophysiology (IFCN) published the Evidence-Based Medicine Guidelines for the Treatment of rTMS, which was updated in 2019;
  • In 2015, “Guidelines for Rehabilitation of Cerebral Palsy in China” pointed out that repetitive transcranial magnetic stimulation technology is an effective adjuvant therapy for children with cerebral palsy (recommended strength: level A); 
  • In 2016, the Canadian Psychiatric Association (CANMAT) recommended rTMS as the first-line treatment in the Guidelines for Clinical Treatment of Adult Depression;
  • In 2020, the International Federation of Clinical Neurophysiology (IFCN) updated the TMS Safety Guidelines issued in 2009, taking into account the safety of new technologies and equipment, and providing operational guidelines for future use of TMS;
  • In December 2020, the National Health Commission issued the “Guidelines for the Diagnosis and Treatment of Mental Disorders (2020 Edition)”, which explicitly mentioned that physical therapy technologies such as repetitive transcranial magnetic stimulation technology should be used as one of the comprehensive treatment methods for depressive disorders.

4.2Expert consensus

  • In 2016, the “Expert Consensus on TMS Treatment of Depression” issued by the American Clinical TMS Society put forward five suggestions on the process of TMS treatment of major depression;
  • In 2016, the American Psychiatric Association (APA) released the “Recommendations of clinical application of TMS in the treatment of depression”;
  • In 2018, the expert team of the electroshock and neurostimulation group of the Neuromodulation Professional Committee of the Chinese Medical Doctor Association released the “Expert Consensus on Repetitive Transcranial Magnetic Stimulation Therapy”, which introduced the safety and efficacy of rTMS treatment in clinical practice, and standardized the treatment process and operation technology.
  • In 2022, the Rehabilitation Group of the Pediatric Branch of the Chinese Medical Association and the Physical Therapy Committee of the Chinese Association of Rehabilitation Medicine set up an expert group to discuss and propose the expert consensus on transcranial magnetic stimulation for children with cerebral palsy based on China's national conditions, recent research results and clinical experience.

4.3Policies of the China's National Health Commission

  • In November 2019, the National Health Commission issued the “Standards for the Establishment of National Psychiatric Centers and National Psychiatric Regional Medical Centers”, and transcranial magnetic stimulation technology was included in the list of key technologies of the two centers; 
  • In November 2019, the National Health Commission issued the “Standards for the Establishment of National Neurological Disease Centers and National Neurological Disease Regional Centers”, taking neurological disease regulation technology as the core technology for the diagnosis and treatment of these two centers.
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