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.
Journal: American Journal of Psychiatry (2019)
Authors: L Carmi, A Tendler, A Bystritsky, E Hollander, D.M Blumberger, J Daskalakis, H Ward, K Lapidus, W Goodman, L Casuto, D Feifel, N Barnea-Ygael, Y Roth, A Zangen, J Zohar
Obsessive-compulsive disorder (OCD) is a chronicand disabling condition that often responds unsatisfactorilyto pharmacological and psychological treatments. Converging evidence suggests a dysfunction of the cortical-striatal-thalamic-cortical circuit in OCD, and a previous feasibilitystudy indicated beneficial effects of deep transcranial magnetic stimulation(dTMS) targeting the medial prefrontal cortexand the anterior cingulate cortex.
To Examine the therapeutic effect of dTMS in a multicenter double-blind sham-controlled study.
At 11 centers, 99 OCD patients were randomlyallocated to treatment with either high-frequency (20 Hz) or shamdTMS and received daily treatments following individualized symptom provocation, for 6 weeks. Clinicalresponse totreatment was determined using the Yale-Brown ObsessiveCompulsive Scale (YBOCS), and the primary efficacy endpoint was the change in score from baseline to posttreatmentassessment. Additional measures were response rates (defined as a reduction of>30% in YBOCS score) at the post-treatmentassessment and after another month of follow-up.
89% percentoftheactivetreatmentgroupand 96% of the sham treatment group completed the study.The reduction in YBOCS score among patients who received active dTMStreatment was significantly greater thanamong patients who received sham treatment (reductionsof 6.0 points and 3.3 points, respectively), with responserates of 38.1% and 11.1%, respectively. At the 1-monthfollow-up, the response rates were 45.2% in the activetreatment group and 17.8% inthe sham treatment group.Significant differences between the groups were maintained at follow-up.
High-frequency dTMS over the medial pre-frontal cortex and anterior cingulate cortex significantlyimproved OCD symptoms and may be considered as apotential intervention for patients who do not respondadequately to pharmacological and psychological interventions.