This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
61% of Unmedicated Treatment Resistant Depression Patients Who Did Not Respond to Acute TMS Treatment Responded After Four Weeks of Twice Weekly deep TMS in the BrainsWay Pivotal Trial
Journal: Brain Stimulation 10(4): 847-849 (2017)
Authors: A.G Yip, M.S George, A Tendler, Y Roth, A Zangen, L.L Carpenter
Background:
An acute course of dTMS typically involves treatments delivered 5 days a week, for 4 weeks.Should more treatments be given if the patient has not responded? Data are needed to inform decisions about the best next steps for acute non-responders.
Objective:
To characterize response among acute-phase non-responders in a randomized controlled trialof deep repetitive transcranial magnetic stimulation (dTMS) monotherapy for medication-resistant depression.
Methods:
Summary statistics and Kaplan-Meier curves were used to characterize outcomes of 33 medication-free BrainsWay dTMS non-responders to double blind but active treatment at the end of 4 weeks (20 sessions), who then continued double blind but active twice weekly treatment for up to 12 additional weeks.
Results:
24 participants (72.7%) achieved responder status during at least one rating with dTMS continuation -20 (60.6%) within four weeks, with 13 (39.4%) consistently meeting response criteria for the duration of the study. 20 (63.6%) achieved remission status at some point during treatment continuation.
Conclusions:
A significant proportion of acute course non-responders to dTMS treatment eventually respond with continued treatment. Continuing TMS treatment beyond the acute course for non-responders may result in eventual response in over half of these individuals.
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Publication & Date: Journal of Affective Disorders 240:130-136 (2018)Investigators: A Tendler, R Gersner, Y Roth, A Zangen