The FDA cleared the way to use this deep transcranial magnetic stimulation system, which may be able to help treat depression in less than 5 minutes.
BrainsWay’s theta burst 3-minute protocol for the treatment of major depressive disorder (MDD) received 501(k) clearance from the US Food and Drug Administration (FDA). The theta burst protocol utilizes BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) system, previously FDA-approved for 20-minute treatments of patients with MDD who did not respond to medical therapy.
“Adding our 3-minute treatment protocol to the list of growing solutions available to our provider partners expands the platform nature of this lifechanging technology,” Hadar Levy, Senior Vice President and General Manager of BrainsWay, said to the press. “Many patients and providers can benefit from significantly shorter treatment sessions, and our theta burst protocol can provide these patients with another option to manage their treatment resistant depression.”1
In their application to the FDA, BrainsWay submitted safety and efficacy data from a study that enrolled 146 participants with MDD who received either standard deep TMS protocol or 3-minute theta burst protocol. Of the 146 patients, 80 received the 20-minute protocol and 66 received the theta burst 3-minute protocol. Both groups demonstrated statistically significant reductions in depression scores. The results met the equivalence criteria needed for the shorter treatment’s clearance.
The therapy uses BrainsWay’s H-1 coil helmet to excite or inhibit neurons in the prefront cortex using direct magnetic pulses. It is typically delivered 5 days a week for 4 weeks, and then adjusted based on patient response. Both treatments call for the same frequency and number of treatments, but the frequency of the pulses and inter-pulse breaks differ.2
“The addition of theta burst to the available protocols further demonstrates BrainsWay’s commitment to expanding the utility of the BrainsWay Deep TMS system,” said Moria Ankri, Vice President of Research & Development. “This protocol shows that innovation need not be revolutionary or radical to have a positive effect on peoples’ lives. Having a 3-minute option for patients has the potential to expand access to care by providing patients with added flexibility in selecting courses of treatment that may fit better with their lifestyle.”1
The BrainsWay theta burst protocol will be available on all BrainsWay systems already installed.
1. BrainsWay. BrainsWay receives FDA clearance for three-minute theta burst treatment protocol for major depressive disorder. News release. April 26, 2021. https://www.brainsway.com/news_events/brainsway-receives-fda-clearance-for-three-minute-theta-burst-treatment-protocol-for-major-depressive-disorder/
2. Boyle A. FDA clears three-minute depression treatment with Brainsway’s theta burst. BioWorld. April 26, 2021. https://www.bioworld.com/articles/506363-fda-clears-three-minute-depression-treatment-with-brainsways-theta-burst