BrainsWay study finds sped-up neurostim regimen eases depression quickly, effectively

Shortcuts aren’t common in medicine, but BrainsWay may have found an effective one for treating major depressive disorder.

The company’s Deep Transcranial Magnetic Stimulation (Deep TMS) technology has been cleared by the FDA to target depression symptoms in a series of neurostimulation treatments that occur once a day, five times a week for four weeks, followed by an optional maintenance period comprising two sessions per week for another 12 weeks—but a trial exploring a variety of protocols that majorly condense the standard treatment period now suggests that safe, effective therapy could set in much sooner.

The authors of the accelerated study, which was published this month in the journal Psychiatry Research, cited “growing interest” in a sped-up treatment regimen across all TMS devices, not just BrainsWay’s, as research has increasingly shown that undergoing more than one treatment session a day can work just as well as the more drawn-out protocols—while producing results much more quickly.

“An accelerated protocol could potentially work better with some patients’ schedules,” Colleen Hanlon, Ph.D., BrainsWay’s vice president of medical and clinical affairs, said in a company announcement about the study findings this week. “While additional research is necessary to fully understand the benefits of accelerated protocols, these initial results are certainly promising as they suggest outcomes can be achieved which are comparable to those resulting from longer, traditional protocols.”

The real-world study looked at a variety of accelerated regimens, with 111 Deep TMS patients receiving either two, three, five or 10 treatment sessions per day.

Across all of those options, after one month, an average of about 80% of the patients had responded to the treatment, and just over half had achieved remission. That’s comparable to the standard once-daily Deep TMS regimen: Real-world study results published earlier this year showed an 82% response rate and a 65% remission rate among patients who’d received at least 30 treatments.

Response rates varied among the accelerated protocols, but not significantly so, according to the new study’s authors. Participants treated twice a day had the highest response rate, at just under 90%, while the 10-a-day group scored lowest, though that still amounted to two-thirds of them responding to the extremely accelerated regimen.

Those responses to the sped-up treatments came within just a few days, typically after 10, 20 and 31 sessions for patients receiving three, five and 10 treatments a day, respectively—which averages out to the third or fourth day of treatment. And that efficacy was long-lasting: A small group of the patients stayed on for follow-up check-ins, and the treatment was found to be durable among about 87% of the 30 patients who completed a two-month check and 93% of the 14 participants who stayed on for six months.

Because of that high response rate, strong durability and the fact that no serious adverse events were reported in the study, its authors concluded that “accelerated Deep TMS protocols are found to be safe, effective therapeutic options for MDD. They offer treatment resistant patients a treatment option with a rapid onset of action and with long durability.”

Though the quicker depression treatment schedules haven’t been cleared by the FDA, BrainsWay said in this week’s announcement that the study results “could be leveraged to support efforts to expand current labeling for Deep TMS.”

In the meantime, the company plans to continue investigating the efficacy of the accelerated protocols, according to its chief medical officer, Aron Tendler, M.D.