THIS ARTICLE FOCUSES MAINLY ON THE REGULATORY STATUS OF TDCS AND HOW TDCS COMPARES TO TMS BASED ON UPDATES IN 2019.
– HOW DOES TMS COMPARE TO TDCS AS FAR AS EFFECTIVENESS AND REGULATORY STATUS?
When comparing technologies like Transcranial Magnetic Stimulation (TMS) and transcranial Direct Current Stimulation (tDCS), the best neuromodulation treatment option for any patient will depend on the patients symptoms and goals. The availability of local treatments may also vary depending on where a patient lives. You should always speak to a doctor about potential medical treatments.
– WHAT ARE SOME PROMISING RESULTS FOR TDCS AS TREATMENT FOR BIPOLAR DEPRESSION?
International regulatory approvals of tDCS are based on dozens of controlled clinical trials for tDCS, including for treatment of depression. Research on tDCS for psychiatric applications is ongoing.
– IS TDCS COMBINED WITH DRUGS?
tDCS trials generally consider tDCS as a stand-alone therapy; or a combination therapy with other forms of treatment such as drugs. Sometimes tDCS is combined with other non-drug treatments such as cognitive training or stroke rehabilitation.
– ARE THERE ANY ADVANTAGES THAT TDCS CAN OFFERS PATIENTS THAT TMS CAN’T OFFER?
It is always important for patients to consider not only the efficacy of a treatment but also any associated side-effects. TMS has been known to produce epileptic seizure albeit under rare circumstances. In contrast, the main side-effects of tDCS are itching and tingling during stimulation that stop right after treatment. tDCS is considered safe when applied using certified equipment and under medical supervision. Users generally experience more discomfort during TMS treatment than tDCS.
Another difference between TMS and tDCS is that TMS requires wall-powered equipment that can only be operated from a doctor’s office and so treatment is always in-clinic. In contrast, tDCS is also offered in-clinic, but because tDCS devices are small and battery powered, ongoing clinical trials are being established as home-based tDCS treatments; including trials for chronic pain, depression, Parkinson’s disease, stroke, and Multiple Sclerosis.
– WHAT IT IS THE REGULATORY STATUS OF TDCS?
Soterix Medical tDCS has among the largest ranges of therapeutic approvals, and is approved for the treatment of different types of depression and/or pain across Europe, Canada, Australia, Brazil, and many additional regions; but is not marketed as an on-label treatment in the United States.
Sooma tDCS is approved in the EU (Class IIa), Canada, Mexico, Singapore, Australia, Indonesia, and Turkey. Neuroconn is approved in the Europe and Korea. Y-Brain tDCS, a Korean based company, is also approved in Korea and the EU. Neurolectrics is a Spanish company with approval in the EU. Ying-Chi is a new tDCS company based in China with a focus on home based tDCS.
– WHAT ABOUT THE FDA APPROVAL PROCESS FOR TDCS?
tDCS remains an off-label treatment in the US but has received support for clinical trials from the US National Institute of Health (NIH), and the National Institute of Drug Abuse (NIDA)—with NIDA interested in supporting tDCS trials for addiction occluding opioids, smoking and cocaine .
Iontophoresis is cleared in the US for a distinct medical indication different from tDCS though both devices apply low DC Current. Iontophoresis devices include the ActivaDose and the IontoDC. Iontophoresis devices such as the Activadose have been adopted worldwide as high quality tDCS alternatives to the available consumer devices.