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How quickly does SAINT work? What is the success rate for SAINT? Who is eligible for SAINT? What is SAINT therapy? What are the side effects or risks of SAINT?
Joining us to discuss is Nicholas Trapp, MD, assistant professor of psychiatry at the University of Iowa. AMA Chief Experience Officer Todd Unger hosts.
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Speaker
- Nicholas Trapp, MD, assistant professor of psychiatry, University of Iowa
Transcript
Dr. Trapp: Now, we have so many different treatment options that are available to patients now for depression. Most people classically think of antidepressant medications. Psychotherapy is the standard options. And now, we have this whole new realm of neuromodulation therapies.
Unger: Hello, and welcome to the AMA Update video and podcast. Today we're talking about a new and potentially groundbreaking treatment for major depression called SAINT neuromodulation therapy. Here to tell us more about it is Dr. Nicholas Trapp, an assistant professor of psychiatry at the University of Iowa. He's calling us today from Iowa City. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Trapp, welcome.
Dr. Trapp: Hi, Todd. Thanks for having me. It's a great opportunity to be here.
Unger: Well, I'm excited to learn more about this new treatment that we're talking about. It's a form of transcranial magnetic stimulation, or TMS. Before we get into that, that sounds very futuristic, somewhere between Elon Musk and Neuralink and electronic therapy on the other electric. Tell us more about that, in general.
Dr. Trapp: So transcranial magnetic stimulation, or TMS, as we call it for short, is really exactly what it sounds like. So it's the use of an electric coil that gets placed up against a patient's head, kind of looks like a little waffle iron, although there are different sizes and variations of these coils. That coil, when you pass electricity through, it will generate a magnetic field, and the brain can translate that magnetic field back into electrical energy. And this can be used to depolarize neurons and very basically, to activate or inactivate different areas of the brain.
Unger: And has that been in use for a long time or no?
Dr. Trapp: So TMS has been around since the 80s, when the first coil was developed. It's been clinically approved for the treatment of major depressive disorders since 2008. It's also been clinically approved for several other largely psychiatric indications at this time, as well as abortion of migraine headaches. And generally speaking, this is a way that we can alter cortical excitability for conditions that we think are related to brain pathophysiology.
So any condition that we think modulating a region of the brain can treat, we can potentially use this as a therapeutic for.
Unger: All right. Well, thank you for that background. Let's talk a little bit more now about SAINT therapy. How is this different from traditional TMS, and why is it more effective?
Dr. Trapp: So SAINT therapy stands for Stanford Accelerated Intelligent Neuromodulation Therapy. And it's different from TMS and a few very important ways. One way to think about it is a very rapid-acting, high-dose form of transcranial magnetic stimulation that can be delivered over five days. A standard TMS course prior to the development of SAINT would take about four to six weeks, sometimes even more weeks of daily treatment.
Stanford Accelerated Intermittent Neuromodulation Therapy condenses that entire six-week course into a five-day period, and actually, even delivers more treatment than a standard six-week course. And that's been very exciting. Early studies have suggested that the remission rate from that treatment is higher than we typically see, even with the standard clinical TMS, with patients sometimes getting 50% to 60% remission. The pivotal trial that was conducted found that in the one-month period after treatment, 79% of patients went into remission, which is just an astoundingly high number for some of these treatment-resistant patients.
Unger: That's almost breathtaking in terms of the results. And that dramatic reduction in the amount of time required for those results, that's pretty astounding.
Dr. Trapp: Yes, it is. And one other important thing is that it's more than just a condensing of a lot of treatment dose into a short period of time. It also involves the use of a personalized functional MRI-guided treatment target. So this involves a patient getting an MRI, specifically a functional MRI that looks at oxygen-level changes in different regions of the brain and uses that information to guide the treatment.
And it does that by generating a connectivity target in the prefrontal cortex of the brain to try to, essentially, modulate downstream regions that we know are involved in depression.
Unger: Now, this new therapy, clearly, has a lot of potential, and University of Iowa is one of the few places offering it right now. How did you get early access to this technology, and how long have you been working with it?
Dr. Trapp: So we've had SAINT available here actually on the order of, I'd say a few months at this time. It's a very new treatment. It has been commercially available since 2022, although, there's been a lot of logistical challenges with rolling this out at different sites.
So I did a fellowship in neuropsychiatry and behavioral neurology at Stanford and worked in the lab of Nolan Williams, who is the developer, and his lab developed this technology. And so we got involved in some research while I was there, and I was able to see some patients who had pretty impressive treatment responses. And then we got involved offering this at Iowa commercially and also, being involved in some clinical trials around the use of SAINT.
Unger: Are you seeing the of outcomes that you were talking about before in your own patients?
Dr. Trapp: We've seen some really impressive outcomes. I would say it's too early for me to say if we have the same response and remission rates that we're seeing in the original trials. We've also thrown some of the most complex and treatment refractory patients at this treatment.
What we've seen so far is, when patients do well, they seem to do very well, and they respond very quickly. It's not common that we have a treatment that can get patients better within a five-day period of time. And so we've had some promising successes there.
Unger: May I ask a layperson question? What's the mechanism by which something like this actually has this impact?
Dr. Trapp: It's a really good question. And like most things in psychiatry, we end up having some ideas, but no definitive answer. And some of that comes down to we don't understand the pathophysiology of depression as an illness itself. It's probably a very heterogeneous illness, potentially multiple causes.
As I mentioned at the beginning, we know SAINT and TMS protocols, in general, seem to alter the excitability of the brain. We know there's areas of the brain when we look at functional imaging, so glucose metabolism or oxygen utilization in the brain, those seem to be abnormal in certain regions of the brain.
We also know from some lesion studies that there's certain parts of the brain, when they get damaged, they put somebody at a higher risk for depression. And we think of TMS as a way of counteracting those abnormal or dysfunctional regions. So there's a whole bunch of things we know TMS does. It alters neurotransmitters, it alters functional connectivity. Which of those things is the secret sauce that leads to the antidepressant effect? We don't completely understand.
Unger: Really interesting and I understood that, so that was well explained. You mentioned migraines up front when we were talking about TMS. Do you see that possibly this kind of SAINT therapy might be used for other conditions in addition to depression?
Dr. Trapp: So the SAINT protocol and accelerated TMS protocols, meaning just condensing treatment into shorter durations have been studied for several different conditions now. I would say some of the best early evidence is for obsessive compulsive disorder, looking at a different treatment target, but using an accelerated protocol and a SAINT-like protocol.
There's also been some early studies at a few institutions looking at bipolar depression and seeing promising early findings.
Unger: Dr. Trapp, another basic question for how do you decide whether medication is the appropriate route, or whether something like SAINT therapy would make more sense?
Dr. Trapp: We have so many different treatment options that are available to patients, now, for depression. Most people classically think of antidepressant medications. Psychotherapy is the standard options. And now, we have this whole new realm of neuromodulation therapies as fancy term for neurostimulation.
ECT, or electroconvulsive therapy, is, the classic form of this, which has been around for over 100 years, is still very effective, but requires general anesthesia. It can have cognitive side effects for patients. Now, we have these rapid acting, non-invasive treatments like TMS and SAINT that require no anesthesia. You can drive yourself to and from the treatment.
We spend a lot of time thinking about what's going to be the best for the patient. Most of the time, these TMS treatments are reserved for patients that have failed multiple medications. Some of that is related to logistics. Honestly, when patients have to think about coming to the hospital every single day for a treatment, that can get pretty daunting. There's parking issues. There's all sorts of issues.
Now, with SAINT, some of these patients will come and stay nearby for a week and are able to go home. And so it's making this more accessible. And there's also the opportunity, I think, for bringing this into the inpatient unit to use it for acutely ill, sometimes suicidal patients with depression. So logistics go into that. Sometimes the level of treatment resistance goes into that. Sometimes the comorbid conditions we're trying to treat will factor into which treatment we choose. But all the is actually pointing TMS seems to work well even early on in treatment, maybe works better early on in treatment, or in combination with psychotherapy or with medications.
So it's moving earlier and earlier in the treatment algorithm. And also, it's stimulating the head. So the side effects are usually scalp pain, headaches. There's a very low risk of seizure, which is why they have to do it in the hospital. But it's a very well-tolerated treatment, even compared to some of our serotonergic medications that can cause sexual side effects and other systemic issues.
So my personal opinion is if I had depression, I would do TMS. I'm obviously very biased and I've seen it work for a lot of people.
Unger: Well, that makes a lot of sense. And thank you for that background. Obviously mentioned logistical challenges, one of which would be, of course, the availability of this treatment. How soon do you think it will be before it's more widely available?
Dr. Trapp: It's a good question as well. Like I said, it's commercially available now. The company that has trademarked, essentially, the algorithm that generates the treatment target is a company called Magnus Medical in California. So this is available now. The challenge is with rolling it out, as I understand them, are logistical in some ways. This is 10 sessions a day for 5 days. So it's a very high dose, high intensity protocol. And that means the patient is here for 50 hours during that treatment week.
And so there's a lot of logistics about being able to offer that treatment. Get patients in in a way that is going to be efficient for them, and get them better quickly. And then there's always the challenge with insurance companies and payment for this. So most people's insurances at this point outside of I believe, Medicare and some other kind of one off insurance companies don't cover this.
And so there's just going to be a lot of education both for the insurance companies and also us educating patients. U.S. educating other providers on how to offer this technology.
Unger: Well, that is just really exciting. And those challenges are obviously very important for us to address, because this treatment appears to have an incredible impact on something that could be pretty debilitating for people.
So I'm just really excited to learn more about this new therapy. Dr. Trapp, thank you so much for joining us today. If you found this discussion valuable, you can support more programming like it by becoming an AMA a member at ama-assn.org/joinnow.
That wraps up today's episode. We'll be back soon with another AMA update. Be sure to subscribe for new episodes and find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
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