This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Transcranial Magnetic Stimulation (TMS) is a noninvasive treatment that uses magnetic fields to regulate the activity of brain structures found to be related to different mental health conditions. As the treatment itself relies on repeated pulses of magnetic fields, it is sometimes referred to as repetitive TMS, or rTMS.
At present, there are two major kinds of TMS therapy publicly available to treat mental health conditions: the above-mentioned standard rTMS; and the more advanced Deep TMS (dTMS). The two share certain similarities while differing in other regards, with standard rTMS being the first type of TMS on the market, and Deep TMS being the only medical device to be FDA-cleared to treat obsessive-compulsive disorder (OCD).
Both standard rTMS and Deep TMS are a noninvasive form of therapy that activates a series of electromagnetic pulses that reach different areas of the brain, either directly or through its internal neural pathways. Repeated over time, these pulses eventually create a regulatory effect within brain structures found to be associated with a number of mental health conditions, helping normalize their neural activity. This in turn helps reduce the frequency and severity of the condition’s symptoms. While standard rTMS has a narrower range of activation, Deep TMS manages to safely reach deeper brain structures directly, which contributes to its higher level of efficacy.
Various studies have shown that both Deep TMS and standard rTMS are safe and effective courses of treatment. A randomized, controlled study published in Clinical Neurophysiology determined that the safety of Deep TMS was comparable to that of a sham group and to standard rTMS. Both forms of TMS were also shown to be well-tolerated and not cause any significant physical or neurological side effects.
Standard and Deep TMS have been found to grant symptom relief to those facing the adverse symptoms of mental health conditions. A 2019 study published in the Journal of Psychiatric Research confirms this: the study, which focused on patients battling major depressive disorder (MDD), concluded that both Deep TMS and standard rTMS caused significantly higher rates of remission when combined with medication, as opposed to medication alone. Studies like this underscore TMS’s efficacy in treating symptoms of mental health conditions, in addition to its ability to be integrated with other forms of therapy.
There are several key differences between standard rTMS and Deep TMS. These include the scope of their magnetic field activation, their level of treatment efficacy, and their FDA clearance status.
Scope of Magnetic Activation
Due to their differing equipment and technology, the magnetic fields created by standard and Deep TMS differ in their size and scope of activity. Standard rTMS relies on a figure-8 coil design, which only reaches a depth of 0.27” (0.7cm). Deep TMS, however, uses a more three-dimensional H-coil helmet design, which manages to encompass a broader surface area and stimulate deeper brain structures directly, reaching a significant sub-threshold of 1.25” (3.2cm). These results were shown in a 2014 Brain Stimulation study. Deep TMS’s advantage lies in its combined ability to not only directly regulate deeper structures linked to mental health conditions, but also to safely target more of these crucial structures during each session. This is because Deep TMS’s magnetic fields spread over wider areas of the brain, while standard rTMS’s fields are activated through a narrower prism, increasing the risk of missing relevant brain structures. For the coils designed to treat depression, the H-coil stimulates approximately 17cm3 of brain matter, while the figure-8 coil stimulates approximately 3cm3.
Putting it simply, Deep TMS’s wider scope of activation allows the treatment to avoid targeting issues, thereby increasing its efficiency.
Since brain structures are not located in the exact same spot for everyone, it is imperative to make each session count. Indeed, recent studies have pointed to the fact that managing to regulate more of the relevant structures can lead to a decrease in symptoms, resulting in a greater quality of life.
Level of Treatment Efficacy
As standard rTMS and Deep TMS’s use different equipment whose magnetic fields reach different depths and ranges within the brain, the two treatments end up affecting patient symptoms with different levels of efficacy. An independent 2019 study published in the Journal of Psychiatric Research found the difference between both treatments to significantly favor Deep TMS, noting that patients with moderate-to-severe baseline depression reached higher rates of response under a treatment course that combined Deep TMS and medication, when compared to either standard rTMS and medication, or medication alone.
FDA Clearance Status
Standard rTMS first received its FDA clearance status to treat MDD in 2008, and was then FDA-cleared to treat certain migraine headaches in 2013. Deep TMS received its FDA clearance status for treating MDD in 2013, and was FDA-cleared to treat OCD in 2018. BrainsWay is working to expand Deep TMS’s clearance status, to treating additional mental health conditions with its proven effective technology.
Deep TMS has also received the European CE certification mark for its treatment of a number of mental health conditions. Receiving the CE mark of approval confirms that Deep TMS meets the health, safety, and environmental benchmarks of products, services and devices sold within the European Economic Area (EEA).
As a result, Deep TMS has been CE-marked to treat the following conditions: MDD, OCD, Alzheimer’s disease (AD), autism, bipolar disorder, chronic pain, multiple sclerosis (MS), Parkinson’s disease, post-stroke rehabilitation, post-traumatic stress disorder (PTSD), the negative symptoms of schizophrenia, and smoking cessation.
With an advanced product that uses cutting edge technology to offer greater results to patients and professionals, it is clear why BrainsWay is leading the charge when it comes to safe, effective and study-backed treatment options for those who need it.