BrainsWay says the FDA cleared an accelerated Deep TMS protocol for major depressive disorder, with a six-day acute treatment phase in the United States.
FDA clearance for an accelerated protocol
BrainsWay Ltd. said the U.S. Food and Drug Administration cleared an expanded set of treatment protocols for its Deep TMS system. According to the company’s September 16 press release, the cleared expansion includes an accelerated protocol for people with major depressive disorder, including people with comorbid anxiety symptoms.
BrainsWay said the accelerated protocol is commercially available in the United States. The company described the clearance as an expansion in how its Deep TMS system can be used for depression treatment.
Shorter acute treatment phase
According to BrainsWay, its prior standard protocol required four weeks of daily treatment sessions before follow-up visits. The newly cleared accelerated protocol has an acute treatment phase lasting six treatment days, the company said.
BrainsWay reported that each accelerated-treatment session lasts less than 10 minutes. The company said it plans to train healthcare providers over coming months as it introduces the protocol and seeks to expand access nationally.
Study results reported by the company
BrainsWay said the FDA clearance was supported by a multicenter, randomized, blinded and controlled clinical study using intermittent theta burst stimulation. The company reported that outcomes for the accelerated protocol were comparable to those for its standard protocol.
According to BrainsWay, HDRS-21 depression scores fell by 19.02 points in the accelerated group and 19.79 points in the standard-protocol group. The company reported response rates of 87.8% for the accelerated group and 87.5% for the standard group.
BrainsWay reported remission rates of 78.0% with the accelerated protocol and 87.5% with the standard protocol. The company also reported a median time to remission of 21 days for the accelerated protocol, compared with 28 days for the standard protocol. No severe adverse events were reported in the study, according to BrainsWay.
What this means for Maryland patients
The clearance may create another scheduling option as Maryland patients look for local TMS treatment. The directory lists 100 published clinics in Maryland, and availability may vary by provider and training status.
This is general information, not medical advice.
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