The largest sample of individuals prospectively treated for a major depressive episode—TMS used among 5,000+ patients is now published in the peer-review literature.
Information is power. It is essential to know the most possible when clinicians make treatment decisions for our patients’ needs.
Over the past 15 years, there have been many studies about Transcranial Magnetic Stimulation (TMS) Therapy. It is clinically evident that TMS Therapy is effective, safe, and durable as a treatment for depression for individuals who have not responded to previous antidepressant medication trials. The early studies demonstrated a level of safety and effectiveness such that my practice began offering TMS Therapy over a decade ago.
At my practice, we provided this option for patients who had not improved adequately with psychotherapy and/or several medication trials. We have found TMS Therapy to be a very positive addition offering patients an alternative when struggling with depression. Now, there are even more options available as ketamine/esketamine, new medications, and augmentation strategies, including combining a non-antidepressant with an antidepressant. Knowing what any treatment looks like with large groups of real-world use over time helps understand how best to use a particular treatment.
We now have that knowledge with TMS Therapy in the largest dataset of treatment for depression ever reported. Clinical Outcomes in a Large Registry of Patients with Major Depressive Disorder Treated with Transcranial Magnetic Stimulation will be published in the December 2020 issue of the Journal of Affective Disorders. Currently, the article is available online.
While most people want the bottom line, I think it best to give some background and end with the bottom line.
In 2008, NeuroStar® was the first TMS Therapy system to obtain FDA clearance to treat depression. Since then, there have been advances in knowledge of neural targeting, stimulation parameters, and treatment schedule. In 2016, to further understand TMS Therapy use in the routine clinical setting, NeuroStar® began a registry to accumulate HIPPA-compliant, confidential information about the treatments.
- 103 practices, mostly private practices, and some university and psychiatric hospital settings
- 5,010 patients diagnosed with major depression, at least 18 years old, had a depression rating scale before and at some point later in their treatment course
- 3,814 patients met the criteria for analysis
- Examine outcomes in routine clinical practice
- Examine potential demographic factors and treatment-related correlates of TMS Therapy clinical outcomes
The clinician response and remission rates were 83 percent and 62 percent, respectively, for the group that completed a full treatment course using the FDA-cleared protocol. These results are in a group of patients likely not to have benefitted from multiple medications before treatment with TMS Therapy or a group often diagnosed with treatment-resistant depression (TRD). This data is a profound result, especially since it includes several thousand patients treated at over 100 facilities. This is a robust antidepressant effect significantly greater than results in earlier studies in this patient population.
These strong findings suggest using TMS Therapy in a treatment-resistant population is important, but unfortunately, it is likely underutilized. Access to TMS Therapy is often limited by insurance company medical policies that require multiple ineffective treatment attempts with medications before allowing access to TMS Therapy. TMS Therapy was developed and tested in a TRD population. However, with this new evidence that it is effective in a less treatment-resistant population, and with its well-established safety profile that includes the lack of medication side effects, TMS Therapy should be considered an appropriate treatment option despite the severity of depression.
The registry study results are exciting, representing the largest study we have about any treatment for depression. The study data provides treating clinicians with exceptional information about TMS Therapy as an effective treatment for the broad spectrum of depression.