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FDA clears deep transcranial magnetic stimulation device to treat obsessive-compulsive disorder

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BrainsWay’s Brain Stim­u­la­tion Device Receives FDA Approval to Treat Obses­sive-Com­pul­sive Dis­or­der (IEEE Spec­trum):

In 2013, Jerusalem-based Brain­sWay began mar­ket­ing a new type of brain stim­u­la­tion device that uses mag­net­ic puls­es to treat major depres­sive dis­or­der.

Now, thanks to pos­i­tive results in a study of 100 patients, the com­pa­ny has received approval from the U.S. Food and Drug Admin­is­tra­tion (FDA) to mar­ket the device for a sec­ond psy­chi­atric condition—obsessive-compulsive dis­or­der (OCD)

Typ­i­cal­ly, non­in­va­sive elec­tri­cal and mag­net­ic fields applied to the scalp, such as in tran­scra­nial direct cur­rent stim­u­la­tion (tDCS), affect wide swaths on the brain, acti­vat­ing every­thing in their path. The most pre­cise meth­ods, deep brain stim­u­la­tion tech­niques, require implant­i­ng an elec­trode deep into the brain.

The new device, how­ev­er, relies on deep tran­scra­nial mag­net­ic stim­u­la­tion (Deep-TMS) to stim­u­late deep brain struc­tures via pow­er­ful, care­ful­ly posi­tioned elec­tro­mag­nets. The Brain­sWay device stim­u­lates the brain at greater depth and breadth than oth­er TMS devices, claims com­pa­ny CEO Yaa­cov Mich­lin. “This allows us to non­in­va­sive­ly tar­get pre­vi­ous­ly unreach­able areas of the brain,” he says.

The Study:

BrainsWay’s FDA clear­ance for its OCD treat­ment was based on a piv­otal, mul­ti­cen­ter study demon­strat­ing that after six weeks of treat­ment, there was a sta­tis­ti­cal­ly sig­nif­i­cant improve­ment in the pri­ma­ry end­point results for the active treat­ment group when com­pared to sham (p=0.0127) … The study was con­duct­ed in a total of 11 med­ical cen­ters, with nine locat­ed in the Unit­ed States, one in Cana­da and one in Israel. Patients who did not suf­fi­cient­ly respond to phar­ma­co­log­i­cal or psy­cho­log­i­cal treat­ment were enrolled in the tri­al and con­tin­ued their phar­ma­co­log­i­cal or psy­cho­log­i­cal treat­ment dur­ing the study. The Brain­sWay OCD treat­ment pro­to­col con­sist­ed of twen­ty-minute ses­sions con­duct­ed five times per week, over the course of six weeks. Impor­tant­ly, a tai­lored provo­ca­tion was applied in each ses­sion to per­son­al­ize the treat­ment for the patients’ spe­cif­ic dis­or­der. Deep TMS treat­ment is non-inva­sive, requires no anes­the­sia and has been demon­strat­ed to be safe and well-tol­er­at­ed.”

More info in the press release

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