FDA Clears 3-Minute TMS Protocol for Depression

The FDA has cleared a three-minute treatment protocol for a repetitive transcranial magnetic stimulation (rTMS) system by Magventure, the company announced last week. The FDA first cleared the rTMS therapy system in 2015 for adults with treatment-resistant depression. Previously, each treatment session using this rTMS system took between 20 minutes and 40 minutes.

The new treatment protocol, which is known as theta burst stimulation (TBS), was cleared on the strength of a randomized clinical study comparing outcomes in adults with treatment-resistant depression who received two to four weeks of TBS with those who received conventional rTMS.

At the end of the study, reductions in depressive symptoms (using the 17-item Hamilton Rating Scale for Depression) were similar between the groups: a 7.8-point drop for TMS and 7.9-point drop for TBS. While self-rated intensity of pain associated with treatment was greater in the TBS group than in the 10 Hz TMS group, dropout rates were similar in both groups. ■