Publication & Date: Brain Stimulation(2018) Investigators: R.E Ross, C.J VanDerwerker, J.H Newton, M.S George, E.B Short, G.L Sahlem, A.J Manett, J.B Fox, C.M GregoryRead More
This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
Chronic treatment resistant depression takes a substantial toll on patients’ quality of life and alternative treatment options are limited.
This prospective multicenter study evaluated the safety, tolerability and efficacy of four weeks of thrice-a-week deep transcranial magnetic stimulation (dTMS) in combination with selective serotonin reuptake inhibitors (SSRIs).
Forty patients who failed to respond during a 16-week double-blind placebo controlled (DBPC) trial of dTMS or sham dTMS as monotherapy were screened and started a treatment of previously tolerable but ineffective SSRI. After ten days of medication, high frequency dTMS was added three times a week for four weeks.
dTMS combined with SSRIs was well tolerated, with only headaches as a related adverse event (n = 4), which did not cause drop outs. Six patients were excluded from analysis: 1 was missing screening data and 5 received less than 10 sessions. Out of 34 patients included in this study, 12 (35.3%) patients remitted (HDRS-21 < 10). No significant differences were found between patients who had received sham or active dTMS in the earlier DBPC multicenter trial.
Thrice weekly dTMS at 120% motor threshold(MT), 10 HZ, 3 s trains, 20 s intervals, 2400 daily pulses, can augment formerly ineffective SSRI treatment.