In late 2020, Roth et al published findings on the real-world use of deep transcranial magnetic stimulation (Deep TMS) to relieve symptoms of obsessive-compulsive disorder (OCD). Deep TMS was FDA cleared for OCD in 2018, as well as major depressive disorder (MDD) and smoking cessation. In general, their results demonstrated a continuous reduction in Yale Brown Obsessive Compulsive Scale (Y-BOCS) scores as Deep TMS sessions increased.

Dr. Ryan Vidrine

Dr. Ryan Vidrine

Dr. Owen Muir

Dr. Owen Muir

Psycom Pro spoke to two of the researchers – Ryan Vidrine, MD, Director of OCD Services at Mindful Health Solutions in San Francisco, and Owen Muir, MD, Chief Innovation Officer at Brooklyn Minds in New York – about their findings and its potential impact on OCD treatment, including for those patients who are refractory to other approaches.

Psycom Pro: Your analysis provides a first look at real-world clinical use of Deep TMS for obsessive-compulsive symptoms. Why was this setting so important?

Dr. Muir: Looking at real-world patients who are suffering from symptoms of OCD is particularly important. Most clinical trials include expert clinicians, expert raters, and carefully selected patients to make sure that all of the convoluted, co-occurring conditions and details of people’s lives that can cause one to skip treatment or engage in a way that we might consider suboptimal for clinical trial purposes, all impact the effectiveness of the treatment. In this context, seeing that patients who are dealing with everything from commuting in the midst of a COVID pandemic, to “not perfect” adherence, as well as real-world, comorbid conditions, can have remarkable outcomes for treatment-resistant OCD. This was extremely heartening.

Clinical trials are a way of studying the potential of different treatments – but when we look at effectiveness in the real world, we find out if it works for our actual patients. This study addressed the question: Does Deep TMS for OCD deserve to be part of the standard outpatient clinical armamentarium?

The answer, we believe, was a resounding “yes.”

Time, Cost, and Protocols for Using Deep TMS

Psycom Pro: Your analysis demonstrated improvement within 20 Deep TMS sessions and further improvement beyond 29 sessions. In practice, what length and frequency of sessions would you recommend? And what challenges – whether clinical or administrative – should clinicians keep in mind?

Dr. Vidrine: Typical Deep TMS is normally spread out over 4 to 6 weeks. During this time, patients come in for sessions 5 times per week and each of these sessions last about 20 minutes.

Most patients with some advanced scheduling are able to make the time commitment without much problem. Many people choose to undergo treatment before or after work, over lunch breaks, between classes, etc. It is quite rare that patients discontinue treatment due to the time commitment.

Financial commitment, however, can vary greatly from patient to patient. While it is possible to get insurance coverage based on an OCD diagnosis alone, coverage is not applied routinely or at the scale we see with major depression, for example, despite FDA clearance. Some patients elect to pay out-of-pocket, but this can be quite expensive and prohibitive to a number of people.

Dr. Muir: What we understand about Deep TMS for OCD is that although 20 sessions are good, and 29 sessions are better, some patients, particularly those with a significant drop in their Y-BOCS scores during the course of treatment, may benefit from a longer course of treatment. The protocol used [in our study] included one daily treatment, 5 days a week for 4 to 6 weeks, and for most patients this is enough. However, these sessions may need to continue to achieve full remission of OCD symptoms, which was not explored in our particular outpatient sample.

Our study did not address patient adherence to the time commitment because the sample was made up of outpatients who had to make a personal time commitment, getting us to the significant improvements of about a 30% reduction in symptoms that we saw. The time commitment is not insignificant, however, if you think about the amount of time people with OCD spend acting on their compulsions and obsessions, one may consider the benefits of effective treatment as quite significant over the course of a patient’s lifetime.

The financial commitment at this time is significant, in part due to the machines, technicians, and infrastructure necessary. In many practices, these additions are not covered by insurance. However, these around payment speak to the need for a more robust effort on the part of patients and the industry to work with third-party payers to ensure and understand the value provided by treatment at this level of effectiveness.

Psycom Pro: Could you talk briefly about the frequency protocols used with Deep TMS application and any relevant guidelines?

 Dr. Vidrine: Both high and low-frequency Deep TMS protocols exist, regardless of the condition being treated. Frequency describes the timing of magnetic pulses. High versus low frequency is thought to have different effects in different areas of the brain and is an area still being heavily explored and researched. BrainsWay* (developer of the FDA cleared Deep TMS device) tested early on both high and low-frequency protocols and found the high frequency to be more effective – high frequency was used in their trial.

Dr. Muir: The compelling data we have for effective treatment was done with an H-7 coil using a high-frequency stimulation – that is to say, 20 cycles per second for 2 seconds and a 20-second pause, repeat. We have not conducted studies that demonstrate compelling efficacy with other versions of transcranial magnetic stimulation, including figure 8 coils or intermittent theta-burst.

FDA has cleared 20-hertz high-frequency treatment with the H-7 coil for OCD, along with the provocation designs. See Figures 1 and 2.

Deep TMS Figure 1

Deep TMS Figure 1

Brainsway Deep TMS Figure 2

Deep TMS Figure 2

Psycom Pro: Do you anticipate OCD symptom improvements after Deep TMS as being long-term or is it expected that patients may need follow-up treatment sessions?

Dr. Vidrine: We don’t know yet to be honest. We certainly see this in depression – that patients who do well in one depression course, tend to benefit in future depression relapses. We have also seen that for some patients, it gets them “over the hump” or “out of the hole” and they sort of keep building from there and do not need future treatment.

I have only retreated three or four patients with OCD who responded well the first time. The bulk of those that I have treated who responded initially tend to build and continue to progress even after treatment ends. Again, this is just anecdotal from my practice, but we will need more large data sets to make any conclusions about the durability of treatment.

How Deep TMS Works for OCD

 Psycom Pro: Your discussion notes: “In this analysis, perhaps the treatment was effective without the use of exposure therapy experts because all that is necessary from the brief provocation is activation of the underlying OCD circuitry, which is accomplished by creating a few minutes of doubt and not allowing the patient to alleviate it through a compulsion.” Could you explain the latter point? 

Dr. Vidrine: There is some thought, based on other work with addiction and PTSD, that simply activating the circuitry involved in OCD fears prior to or during stimulation could enhance treatment outcomes. This is what we are attempting to do when we talk about “provocations.”  We are literally “provoking” or triggering a bit of the fear (in a controlled, thoughtful manner) for the patient.

This tactic often does not require very much effort as patients typically know exactly how to do this. Sometimes, even just talking or thinking about something is enough to trigger it. When we do this, and then help patients resist giving into compulsions – we are applying basic Exposure-Response Prevention therapy, just done in a simple and time-limited way.

Would results be even better if we paired Deep TMS with an expert exposure therapist? Probably. Would Deep TMS still work or work as well if we eliminated provocations altogether?  We don’t know. There have not been head-to-head studies like this yet, but I know people are thinking about these questions.

You could imagine studying Deep TMS by itself, Deep TMS plus brief provocations, and Deep TMS plus expert exposure therapy. Because so many of our patients who respond to Deep TMS have already tried Exposure Response Prevention therapy in the past and not received the results they are looking for, we believe Deep TMS is doing something important on its own.

Dr. Muir: It is unclear whether the exposure or provocation necessary for the effectiveness of the treatment to be at its maximum has to do with it being administered at the very beginning of a Deep TMS treatment or continuing throughout the entire treatment period. This is an empirical question yet to be answered. However, in our practice, we encourage technicians to keep the level of doubt and uncertainty between 4 and 7 on a visual analog scale (VAS) to maximize the potential effect of the stimulation, while the OCD circuitry in the brain is more or less “on.”

One way we think Deep TMS for people with OCD is by enhancing the effects of the breaks in the brain on the OCD loop that is kind of spinning and spinning. The more we spin the wheel, the more exercise the brakes get at slowing it down. This is a simplified explanation, but it gives you some sense of the rationale behind continuing provocation throughout the treatment period.

 

The Potential of Deep TMS for Refractory OCD and Severe OCD Symptoms

Psycom Pro: Your team’s data show that subjects had a mean of 5.8 lifetime failed medications for their OCD. Could you offer any insight into why individuals with OCD are commonly refractory to traditional approaches? Also, do you see Deep TMS as a complementary or standalone treatment for OCD?

Dr. Vidrine: Trying five or more medications is not unusual in mental healthcare, regardless of diagnosis. We see this commonly with depression as well. “Failed medications” can sometimes mean that even though the medication helped reduce symptoms, there were side effects that made it intolerable for ongoing use. We also know that OCD patients are often misdiagnosed and often not prescribed evidence-based treatments for many years after their symptoms start, leading to their OCD becoming worse and more difficult to treat over time.

The trial that led to FDA clearance studied people using Deep TMS as an adjunctive treatment to medications. We will need more substantial research to definitively discuss its role as a standalone treatment. In my clinical practice, I am particularly fond of using Deep TMS to augment Exposure-Response Prevention therapy for OCD, but we have certainly used it in a variety of settings including augmenting medications and therapy, and occasionally standalone with varied results from patient to patient.

Dr. Muir: I agree with Dr. Vidrine’s response and to add, this does beg the question: if Deep TMS is so effective in patients in whom nothing else has been helpful, might it be a better first-line treatment? The answer there is probably yes, but the point of research is to determine whether a “probably” turns out to be “true” in a gold standard approach.

It might be that there’s something biologically different about treating refractory OCD compared to non-refractory OCD. What we do know is that OCD is a disorder of deep structures in the brain, which is an area difficult to get to respond to traditional treatments robustly. I see the massive effect size of Deep TMS for OCD as something that hints at its broad applicability across OCD diagnosis and treatment, but further studies will be necessary to elucidate this possibility.

Psycom Pro: In your view, would Deep TMS be best indicated for a specific subset of OCD patients, such as those with more severe symptoms?

Dr. Muir: Deep TMS for OCD was studied in a population of OCD patients who had failed other treatments. The patients in our care were treated because they came for treatment with something that would work when other things had not. This indicates that, given the impairment in their life, they were willing to subject themselves to several weeks of treatment at a time, and possibly pursue a financially intensive treatment option.

We have not been able to study Deep TMS in OCD for those with less severe symptoms that are not treatment refractory, and it may be that it’s effective for those patients as well. However, at this time, the answer to that question is not clear.

What to Explain to Patients Considering Deep TMS

Psycom Pro: Let’s talk about patient counseling. You mentioned time commitment and insurance – what else do providers need to share with patients in advance about undergoing Deep TMS?

 Dr. Vidrine: We talk about the schedule, common side effects, medication plan (usually trying to keep it consistent during treatment), contraindications (epilepsy, cochlear implants, ferrous metal or devices in the head). We talk about the risk of seizures, which is quite small, but possible. I usually encourage patients to practice resistance of compulsions as much as possible, and not set them up to believe that Deep TMS will magically make all of their OCD disappear. Aside from that, we usually discuss their fear hierarchy and what their day-to-day provocations look like.

Dr. Muir: We also make sure to indicate that the treatment can be uncomfortable, particularly in the beginning, but that it gets more tolerable with time.

Headaches can be common, but given the side effects, most patients have endured with other treatments for OCD, the list of side effects is honestly relatively modest and is well tolerated across most patients.

Case Examples: What to Expect after Deep TMS Treatment

Psycom Pro: Could you give an example of a patient with OCD whose behavior may change – and how it may change – after Deep TMS treatment? In other words, what can clinicians expect to see?

 Dr. Vidrine: What I see most often is patients reporting that they have an easier time resisting compulsions and can more easily ignore intrusive thoughts. We call this an improvement or increase in “cognitive control.” It is much less often that patients report that obsessions or intrusive thoughts have completely gone away. After all, everyone can ruminate or have what some may call “weird” or uncomfortable intrusive thoughts. These thoughts become OCD, so to speak, when the person stays on the thoughts, gives the thoughts more stage time, and/or changes their behaviors in irrational ways because of the thoughts.

So regardless of the OCD presentation, I most often see patients who have had a good response, describing more ability to stay in the present, ignore obsessions, and resist giving into compulsions. This change is something patients have often tried practicing before but report finding it easier to achieve with Deep TMS.

Dr. Muir: A good example may be a patient with the contamination subtype of OCD. They may spend many minutes to hours of everyday checking, rechecking, and washing their hands, seeking reassurance from others about whether they have contaminated them or not, and all the other behaviors that go along with worrying about dirt, germs, or contamination.

This obsession can lead to hours upon hours of the day spent in the shower on specific rituals, cleaning behaviors, etc.

One of the things we would expect after Deep TMS treatment in this type of patient is that much less of their day is taken up with these tasks. This does not mean people stop worrying about dirt or germs. It does mean that they are given more choice or free will about how to spend their time. When they do have worrying thoughts, they may be able to wash their hands for 20 seconds and not for a half-hour or more.

Beyond contamination OCD, there are many patients who suffer with what we call, “pure O” or predominantly obsessive symptoms around OCD. For example, they may think about suicide or attempting suicide in an intrusive and repetitive way, even though they do not actually want to kill themselves. This type of thinking and behavior can be extremely distressing.

Effective treatment for OCD, in this case, would lead to much less of these intrusive thoughts and much less distress, were they to have them going forward. This could, in fact, represent a major change in quality of life for many patients and, in some cases, save lives.

The Future of Deep TMS for Mental Health Disorders, Addiction, and Pain

Psycom Pro: As noted, Deep TMS is FDA cleared for smoking cessation and depression as well as OCD. Are there additional conditions where you see its future application?

Dr. Vidrine: Deep TMS is being actively investigated and looks promising for a variety of conditions including PTSD, addiction, and neurological applications such as cognitive impairment, chronic pain, and post-stroke rehabilitation.

Dr. Muir: I am most excited about applications for bipolar disorder, substance use disorders (SUDs), and chronic pain.

 Psycom Pro: Is there potential for this type of treatment/device to move into home-based or self-care?

Dr. Vidrine: People are certainly researching the potential for magnetic or electrical stimulation devices to be used at home without direct medical supervision. There are versions of this for migraine abortion and people are looking into transcranial direct current stimulation (tDCS) which emits electrical stimulation through the scalp.

The kind of Deep TMS that we are talking about here is still not safe to be managed by patients alone or by anyone without sufficient training, and the devices themselves are quite expensive. Think about this like an MRI or other kinds of medical devices. “Wearables” are definitely something for the future, but not readily or clinically applicable just yet. When they do happen, you could imagine something similar to the model of DBS (deep brain stimulation), where a provider recommends or sets a device to a specific range of settings that a patient can take home and adjust themselves, but only within a safe range determined by their physician.

Dr. Muir: Significant scientific advancement will be necessary before that is the case, but never say never. I think it’s important to recognize this treatment has significant risks including seizures. And that’s not the kind of thing you want to be dealing with at home or by one’s self. Furthermore, provocations are an important part of this treatment. Given the current expense and training necessary to administer the treatment, getting it into the home will be more difficult than one might think, but again, advances in the field are ongoing.

I think it is important to understand that Deep TMS is a little bit like “medication” and that different treatment protocols, different coil designs, and different targeting are going to be beneficial to the field of psychiatry in the coming years. We have been thrilled with the results we have received for depression, smoking cessation, and OCD. Frankly, with the H-coil technology, the hits just keep coming. We are excited to have more effective options for treatment across a broad range of neuropsychiatric conditions and for the investment, as well as research, to continue in this domain.

 

*Neither Dr. Vidrine nor Dr. Muir have any financial ties to Brainsway.
Images courtesy of interviewees.

Last Updated: Feb 19, 2021