Accelerated TMS protocol gains FDA clearance
The treatment landscape for major depressive disorder (MDD) just got a major update. The FDA has cleared an accelerated TMS protocol for depression, making the therapy available in a faster and more convenient schedule for patients struggling with depressive episodes and related anxiety symptoms. This clearance applies specifically to Deep Transcranial Magnetic Stimulation (Deep TMS) developed by BrainsWay, which has already been approved for conditions like obsessive-compulsive disorder and smoking addiction.
Traditionally, TMS treatment required four weeks of daily sessions, each lasting about 20 minutes, followed by follow-up visits. This schedule could be demanding for patients juggling work, school, or family responsibilities. The newly approved accelerated approach significantly reduces that burden without sacrificing effectiveness.
How the accelerated protocol works
Instead of weeks of daily sessions, the accelerated TMS protocol involves an acute phase of just six treatment days. During this period, patients receive five Deep TMS sessions per day, each lasting under 10 minutes. Afterward, they transition to a maintenance phase with two sessions per day once a week for four weeks.
This is a striking contrast to the standard protocol, which required five sessions per day for four weeks, with each session lasting longer. The change means fewer total days of treatment, less time in the clinic, and potentially faster relief for patients.
Results from clinical trials
The FDA’s decision was based on results from a recent randomized study with 104 patients diagnosed with major depressive disorder. Participants were divided into two groups: one received the accelerated TMS protocol while the other followed the standard schedule.
Key findings included:
- Depression scores dropped by 19.1 points in the accelerated group and 19.8 points in the standard group, showing nearly identical improvements.
- Response rates were also similar, with 87.8% for accelerated TMS versus 87.5% for the standard protocol.
- Remission rates were 78% in the accelerated group compared to 87.5% in the standard group.
- Median time to remission was 21 days with accelerated treatment, compared to 28 days with standard treatment.
These outcomes suggest that the accelerated TMS protocol delivers comparable results to the traditional method while significantly shortening the treatment timeline.
What this means for patients and providers
For patients, the biggest advantage is time. A shorter treatment course can mean less disruption to daily life and quicker relief from symptoms of depression and anxiety. For providers, the change may improve clinic efficiency and allow more patients to access care.
However, there are some practical hurdles. Current insurance reimbursement policies typically cover only up to two TMS sessions per day, while the accelerated protocol involves five daily sessions during the acute phase. BrainsWay has announced that it will provide training for healthcare professionals and will work with insurers to update reimbursement guidelines to reflect the new protocol.
The future of TMS treatment
The FDA clearance of the accelerated TMS protocol marks an important step forward in depression care. By maintaining clinical effectiveness while reducing treatment time, this option may increase access and adherence for patients who found the standard schedule difficult to maintain.
As clinics adopt this protocol and reimbursement policies evolve, accelerated TMS could become a new standard for treating major depressive disorder. This development highlights how innovations in neuromodulation continue to reshape the future of mental health treatments.
References
- BrainsWay press release: “BrainsWay Receives FDA Clearance for Accelerated Deep TMS Protocol for Non-Invasive Treatment of Major Depressive Disorder (MDD).” https://investors.brainsway.com/news-releases/news-release-details/brainsway-receives-fda-clearance-accelerated-deep-tms-protocol?utm_source=chatgpt.com
- MassDevice coverage: “FDA clears accelerated protocol for BrainsWay Deep TMS in depression.”https://www.massdevice.com/fda-clears-accelerated-protocol-for-brainsway-deep-tms-in-depression/?utm_source=chatgpt.com