TMS FDA Approval Timeline and Key Studies
2008: FDA Approval for Treatment-Resistant Depression
The first FDA approval for TMS came in 2008. This landmark decision followed rigorous studies that demonstrated TMS’s effectiveness and safety for adults with major depressive disorder who had not responded to at least one antidepressant medication.
Key Study: O’Reardon et al., 2007
In a randomized, controlled trial published in Biological Psychiatry, researchers found that patients treated with TMS experienced significantly greater improvement in depression symptoms compared to those receiving a placebo. This study was foundational in the FDA’s decision to approve TMS for depression, as it demonstrated both safety and efficacy with a high response rate in patients who had previously found no relief with medication.
FDA Decision Date: October 2008
The FDA authorized the use of TMS for adult patients with TRD based on evidence showing TMS was safe and well-tolerated, with benefits that extended beyond the treatment period.
2013: FDA Expands TMS Indications to Include Additional Devices
Following TMS’s initial approval, the FDA evaluated additional devices and approved new TMS systems, including Brainsway’s Deep TMS device, which allows for a broader and deeper magnetic field penetration into the brain, targeting additional areas linked to depression.
Key Study: Levkovitz et al., 2015
This study, published in The World Journal of Biological Psychiatry, tested Deep TMS’s impact on patients with depression and confirmed that the new system was safe and effective. Deep TMS showed promising results, with many patients experiencing a rapid reduction in symptoms, which contributed to its FDA approval.
FDA Decision Date: January 2013
The FDA approved Brainsway’s Deep TMS system for MDD, expanding treatment options
for patients and introducing a new device that could target brain regions more effectively.
2018: FDA Approval for TMS in Treating Obsessive-Compulsive Disorder (OCD)
As research continued to support TMS’s benefits beyond depression, the FDA approved TMS for obsessive-compulsive disorder (OCD) in 2018, marking it as the first non-invasive neuromodulation treatment for OCD.
Key Study: Carmi et al., 2019
Published in The American Journal of Psychiatry, this study evaluated the effects of Deep TMS on patients with OCD, showing a significant reduction in symptom severity after treatment. Patients treated with TMS experienced improvements that were maintained over time, supporting TMS’s efficacy for OCD.
FDA Decision Date: August 2018
This approval expanded TMS’s use, providing a new treatment option for individuals with OCD who had not found relief from traditional therapies.
2021: TMS Approval for Smoking Cessation
In a surprising development, TMS gained FDA approval for smoking cessation in 2021, broadening its therapeutic applications beyond mental health to include addiction.
Key Study: Dinur-Klein et al., 2014
This early study, published in Biological Psychiatry, demonstrated TMS’s effectiveness in reducing cigarette cravings and consumption in smokers. Patients undergoing TMS therapy were able to maintain reduced smoking rates, and the findings contributed to TMS’s approval as a tool for smoking cessation.
FDA Decision Date: August 2021
The FDA approved TMS as a smoking cessation aid, allowing it to be offered as a treatment for individuals seeking help in quitting smoking, marking another significant milestone in TMS’s medical applications.
Why Choose FDA-Approved TMS Therapy?
With each FDA approval, TMS has proven itself to be not only a safe and effective treatment for
various conditions but also a therapy backed by rigorous research and real-world results. Here
are some reasons why FDA-approved TMS may be right for you:
Safety and Reliability
Every FDA approval requires strict testing and evidence of safety and efficacy. TMS has consistently met these standards, providing patients with peace of mind.
Non-Invasive and Minimal Side Effects
Unlike medications, TMS does not cause systemic side effects, making it a great option for those who are sensitive to or unable to take antidepressants. Side effects of TMS are generally mild and temporary, including possible headaches or scalp discomfort.
Effective for Treatment-Resistant Conditions
TMS is especially beneficial for people with treatment-resistant depression and OCD. Studies show that TMS can achieve significant symptom relief, even when other treatments have failed.
Ongoing Research and Expanding Approvals
The FDA continues to review and approve new applications for TMS, showing that its benefits may extend even further. Patients can expect TMS technology to advance as research uncovers new ways it can support mental health and wellness.
Frequently Asked Questions
Is TMS covered by insurance?
Yes, most insurance companies cover TMS for depression, particularly for individuals who have tried multiple antidepressants without success. Coverage varies by provider and condition, so check with your insurance for specific details.
How long does a typical TMS session take?
A typical TMS session lasts around 20-40 minutes. Treatment usually involves daily sessions for several weeks, depending on the individual’s treatment plan.
Are there any serious side effects with TMS?
TMS is generally well-tolerated, with few side effects. Some patients may experience mild headaches or scalp discomfort, but these usually subside after the first few sessions. Serious side effects are extremely rare.
Who qualifies for TMS therapy?
Candidates for TMS therapy include those with major depressive disorder who have not responded to at least one antidepressant. Individuals with OCD or who are looking to quit
smoking may also qualify.
Start Your Journey with FDA-Approved TMS Therapy Today
If you or someone you know is seeking an alternative to traditional treatments for depression, OCD, or smoking cessation, TMS may be the solution. With FDA approvals spanning over a decade and supported by rigorous studies, TMS offers a promising future in mental health treatment.
