What is the accelerated deep TMS protocol?
The accelerated deep TMS protocol is a newly approved treatment approach for people with major depressive disorder (MDD). Deep transcranial magnetic stimulation (deep TMS) is a non-invasive therapy that uses magnetic fields to stimulate brain regions linked to mood regulation. Traditionally, patients needed to attend daily sessions for several weeks, but the protocol reduces both the number and length of visits while maintaining the same effectiveness.
Why is this important for depression treatment?
Many people with depression struggle with the long commitment required by standard TMS schedules. Daily visits over four to six weeks can be challenging for those balancing work, family, and other responsibilities. The FDA’s clearance of an accelerated deep TMS protocol gives patients a shorter treatment option without sacrificing safety or outcomes. For individuals who have not responded to medications, this represents a more flexible and accessible pathway to recovery.
What did the clinical trial show?
The FDA’s decision was based on results from a large, multicenter randomized study involving 104 patients with depression. This trial compared the accelerated deep TMS protocol to the standard protocol. Both approaches showed nearly identical improvements in depression symptoms.
Patients in the accelerated group had their Hamilton Depression Rating Scale scores drop by about 19 points, nearly the same as the standard group. Response and remission rates were also very similar, with no serious side effects reported. Importantly, patients in the accelerated group reached remission faster, in about 21 days on average, compared to 28 days for the standard schedule.
How does the new protocol work?
The accelerated deep TMS protocol condenses treatment into fewer days while keeping sessions short. Patients receive five sessions per day for six days during the acute phase. After this, they attend two sessions per day once a week for four weeks. Each session lasts less than 10 minutes.
In contrast, the standard deep TMS protocol requires daily sessions for four weeks, followed by additional treatments. Each standard session takes about 20 minutes. The new approach means patients spend less total time in the clinic while still benefiting from the therapy.
What does this mean for patients and providers?
This clearance is more than just a regulatory update—it represents a meaningful shift in how deep TMS can be delivered. Faster protocols may help patients stick with treatment and reduce barriers like travel, scheduling, and cost. Providers will need training to adopt the new protocol, and updates to insurance reimbursement will be essential to make it widely available.
According to BrainsWay, the company behind this deep TMS system, the accelerated option also expands treatment for patients with both depression and anxiety symptoms. This is especially significant because many individuals with depression also experience comorbid anxiety, which can make treatment more complex.
Looking ahead
The accelerated deep TMS protocol highlights how innovation in neuromodulation therapies is reshaping psychiatric care. By offering a safe, effective, and faster alternative, the FDA has opened the door for more patients to access life-changing treatments. As clinics begin to adopt this protocol, it may become a key tool in addressing depression for those who have not responded to traditional medications.
References
- BrainsWay. FDA clearance for accelerated deep TMS protocol for major depressive disorder. Benzinga. September 16, 2025. https://www.benzinga.com/pressreleases/25/09/g47688560/brainsway-receives-fda-clearance-for-accelerated-deep-tms-protocol-for-non-invasive-treatment-of-m
- BrainsWay. Multicenter randomized study of accelerated deep TMS for depression shows positive results. June 11, 2025. https://investors.brainsway.com/news-releases/news-release-details/brainsway-reports-positive-results-multicenter-randomized-study