Tag: medical

SAINT The Best Transcranial Magnetic Stimulation (TMS) Therapy Protocol Ever  

We all know how difficult treatment resistant depression (TRD) is for both the patient and the clinician. Wouldn’t it be great if we had a noninvasive method to treat these cases with better efficacy than ECT? What if I told you there is a new type of TMS that leads to remission in 80% of the most difficult to treat cases of depression? Would you be interested? Let’s Find out. 

Introduction:

SAINT stands for Stanford Accelerated Intelligent Neuromodulation Therapy, try saying that one three times fast. 

This is not a new concept as SAINT uses a noninvasive neuromodulation therapy (TMS) in patients with treatment resistant depression and it has shown some real promise in that area.

Treatment resistant depression (TRD) can affect up to 30% of patients with major depressive disorder and as you might expect it’s hard to treat these cases. When a patient reaches this point, things like off-label medication prescribing, ECT and Ketamine are used. However, the FDA just approved a new version of TMS that is reported to have an 80% remission rate in these patients. 

The approval came quick as this device has received breakthrough status by the FDA based on the impressive results from study that included 22 participants with TRD. 19 of the 22 participants achieved remission which in terms of percentage was 86.4% of participants. This is substantially better than other treatments for TRD including ECT which come in around 50%-70% depending on the study you read. 

What Is SAINT?

SAINT was first developed at Stanford University. What sets this TMS procedure apart from other methods of TMS is the intensity of treatment (10 sessions per day) carried out over the course of 5 days. Each session is 10 minutes in length. The intelligent portion of the name has to do with the use of MRI/fMRI-guided theta burst stimulation ensure proper placement of the coil on the dorsal lateral prefrontal cortex. 

This device made it out of the academic arena and is now being distributed by a private start up company called Magnus Medical. You can get on the waiting list now to purchase one of these machines if you feel compelled to do so after this talk. To be clear I have no affiliations with the company.

What Research Lead to FDA Breakthrough Status Approval?

In general devices are not held to the same standard as medications when we are talking about FDA approval. It’s much easier to get a device approved. 

The initial work was carried out with an open label format which is usually considered a lower form of evidence when compared to randomized controlled trials. The research group eventually published a randomized controlled trial in the American Journal of Psychiatry which is largely what allowed SAINT to gain FDA approval. In this study 32 participants with TRD were randomized to active treatment or sham. In this study they used percent reduction from baseline MADRS score 4 weeks after treatment which was found to be 52.5% in the SAINT group and 11.1% in the sham group. The remission rates in this study were 79% for the treatment group compared to 13.3% in the sham group. 

These are significant results in the most difficult patient population to treat. It’s important to point out that these participants had 10 hours of contact with the treatment team per day and the number of participants in the study was small. Both are confounding factors, but using sham treatment helps because most participants were not able to tell if they received the treatment or sham. The one thing that was more common in the treatment group was headaches which may have altered them to which groups they were randomized into.

The authors justified the low number of participants because they achieved a very large effect size with statistical significance without additional participants. What is currently missing from the research is a large randomized controlled trial conducted independently of the research group who designed the protocol (something to look out for in the future). 

Mechanism of Action (MOA)

One question you may have been thinking about is how does TMS work and what is the proposed mechanism of action for SAINT? 

TMS is a noninvasive method of modulating specific areas of the brain by generating a magnetic field which induces neural cell membrane potentials to depolarize in the brain under the coil. Placing the coil in the correct location is critical and there is a 30% chance of missing that location when MRI is not used to map the exact location of the dorsal lateral prefrontal cortex. 

SAINT is thought to alter brain connectivity and increase neuroplasticity in ways that traditional forms of TMS do not. The preliminary evidence suggests connectivity between the amygdala, insula, and medial frontal gyrus is altered in a meaningful way resulting in the improvement in depressive symptoms. Studies are underway to assess the MOA further. 

How Does SAINT Differ From Other Forms of TMS? 

First it differs in the time frame, it takes place only 5 days while most other forms of TMS take a full 6 weeks to complete. The treatments during those 5 days are intense, it requires 10 treatments per day while standard TMS is usually once per day. 

The time for each treatment in the SAINT protocol is much shorter lasting approximately 10 minutes compared to the 20 to 45 minutes usually required. 

There are three established types of TMS that differ in the time it takes to complete the treatment session. 

-The first one on the market was the figure 8 coil which took 45 minutes to complete each session 

-The H coils were invented by Brainsway and these sessions take 20 minutes 

-Theta-burst stimulation: only take 3 minutes, and this is the one that the SAINT protocol uses 

The next question is where to place the coil and how to place it. Traditionally the coil is moved around until the thumb twitches, this is the so-called thumb center, and we can look at the homunculus drawing and see how large the thumb center is. Traditionally we would measure 7 centimeters away from the thumb center and that should be the left dorsolateral prefrontal cortex. This method is not very accurate missing the mark approximately 30% of the time. To fix this problem the SAINT protocol uses MRI guided imaging to be sure the coil placement is accurate. You can also use EEG or PET scans to guide placement. 

Conclusion

-While I’m glad there is innovation in TMS treatment, and the results thus far have been impressive we have to keep in mind this machine is now being marketed by a startup company and has left the world of academia. 

-It’s unclear if you need their machine to produce similar results as theta burst TMS already exists and MRI guided placement of the coil on the dorsal lateral prefrontal cortex exists as well. The company claims they have developed an algorithm for placing the coil that is unique and this claim will need to be investigated further once the machines are available. 

-Another concern is most of the research has been published by the same group that designed the protocol and has not been reproduced in large RCTs independently. 

-My final concern is regarding the application of this treatment for the average patient. It requires a full 5 days and 10 hours of treatment over the course of the 5 days. This may or may not be feasible for the average patient with treatment resistant depression. We haven’t even talked about what this intensive treatment will cost and if insurers will pay for it, another potential barrier. 

-I would also like to see this go head-to-head in a study with Ketamine infusions and ECT. 

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Guide To Viewing My Content

If you are new to the blog and my social media content, we should start with a brief introduction. 

My name is Dr. Garrett Rossi, I’m a medical doctor who specializes in adult psychiatry. I’m board certified by the American Board of Psychiatry and Neurology. I’ve practiced in multiple settings including inpatient, outpatient, partial care, assertive community treatment teams, and I provide ECT services.

I make mental health content on multiple social media platforms and each one has a specific style and type of content. 

Shrinks In Sneakers YouTube Click Here

This is where you can find the deep dives on mental health topics including medication reviews, psychiatric diagnosis, and various other topics. Videos can range anywhere from 5-20 minutes and time stamps are available in the descriptions for longer content. 

Shrinks In Sneakers Instagram Click Here:

This is where you can find shorter videos and posts on mental health topics. The focus on Instagram is more on mental health advocacy, and myths about psychiatry and mental illness. The content here is shorter but still has a lot of educational value. 

Shrinks In Sneakers LinkedIn:

This is where you can find more information about my professional activities. I have information about my advocacy work, professional memberships, publications, and is another good place to follow my work. I make frequent posts here as well. 

Shrinks In Sneakers Twitter: 

Here I’m not very active and haven’t spent much time but I do update blog posts and other relevant information here as well. 

If you have a question or want to get in touch with me, I am most active on YouTube, LinkedIn, and Instagram. 

We are building a community where empathy is a central part of the content. The goal is to make psychiatry more accessible, provide education, and reduce stigma associated with mental health treatment. 

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Shrinks In Sneakers Reunite: Bound by Love for Psychiatry

I think everyone needs a person in their medical training that they bond with and lean on during this difficult period. 

Medical training has its ups and downs, the process is filled with highest highs and the lowest lows. There were moments that I loved training and there were moments where I hated training. 

I was lucky enough to find a great person to share these experiences with.  

We spent many hours discussing psychiatry, what excited us about the field and what worried us about the future. We discussed difficult cases and the drama of residency training. If I ever needed help or someone to cover a call shift last minute, I knew who I could count on.

I could trust this person to have my back and I would do the same no matter what. 

 I would encourage anyone who is going through this process to find someone who can help them grow as both a physician and a person. 

It’s always comforting knowing we can all get by with a little help from our friends. 

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How to Manage Aggression with Psychopharmacology in an Inpatient Setting

I’m very careful about the content I consume and the resources I use to grow as a psychiatrist.

When I endorse something like The Psychiatry & Psychotherapy Podcast, you know it’s something I personally use and trust. 


I had the opportunity to work with Dr. Puder on a recent episode How to manage aggression with psychopharmacology in an inpatient setting. Unfortunately, I got caught up taking care of patients on my inpatient service on the day of the recording and did not get to talk with Dr. Puder and Dr. Cummings.

I would encourage you to listen to all the episodes, but my personal favorites are the ones with Dr. Cummings. He has a wealth of knowledge and I’ve learned some amazing clinical pearls that I apply in my daily practice. 

Check out the episode, you will not be disappointed

https://www.psychiatrypodcast.com/psychiatry-psychotherapy-podcast/episode-145-how-to-manage-aggression-with-psychopharmacology-in-an-inpatient-setting

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What is Aphasia?

Aphasia is an inability to comprehend or formulate language usually due to damage to specific brain regions responsible for these processes. 

There are two important points here to note: 

1. Aphasia is the consequence of another brain disorder such as stroke, brain tumor, traumatic brain injury, viral infections like HSV or neurovegetative process (think dementia here). 

2. There are different types of aphasias, most notably they can be broken down into expressive and receptive aphasia

To be diagnosed the person must have significant impairment in one or more of the following

1. Auditory comprehension

2. Verbal expression

3. Reading and writing

4. Functional communication

About 2 million people are affected by this disorder in the U.S. and strokes account for most of the documented cases. 

One of the most common presentations is anomic aphasias where individuals have word retrieval failures and cannot express the words they want to say (usually nouns and verbs). Some level of this is seen in all types of aphasia.

There can be many other presentations including: 

-inability to comprehend language 

-inability to pronounce words

-inability to speak spontaneously

-inability to read 

-inability to write 

The two most common examples: 

Receptive aphasia (Wernicke’s):

This is a fluent aphasia where the person can speak in sentences but there is no meaning, unnecessary words, and possibly the creation of new words called neologisms. 

-They have poor auditory and reading comprehension.

-There is fluent but nonsensical written or oral expression.

-Since thy do not comprehend language well they are often unaware of their mistakes. 

-The area of the brain affected is well known and established it’s the left temporal lobe as indicated in the picture. 

Expressive aphasia: Broca’s 

-These individuals will speak in short, meaningful phrases with great effort. It will be noticeable how much effort they are putting into speaking. 

-They are usually able to understand the speech of others and are aware of the difficulties they are having leading to frustration. 

-The location of the brain injury is well established, damage to the frontal lobe causes this presentation 

Primary progressive aphasia 

-This is a form of dementia 

-Characterized by gradual loss of language functioning while other cognitive domains such as personality and memory are mostly preserved 

-It usually starts with sudden word finding difficulties and progresses to reduced ability to form grammatically correct sentences, and impaired comprehension 

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Medication Side Effects: Doctor my mouth is a little dry

Regular Dental Care and Oral Hygiene

Dry mouth is another common side effect from psychiatric medication. Patients on psychiatric medication often have poor dental care and poor dental outcomes. There is increased incidence of dental caries and oral ulcers in this population. This patient population is also three times more likely to lose all their teeth. Let that sink in for a moment. Now some of this is related to not following the recommended dental hygiene guidelines such as regular cleanings at least every 6-months. Thus, this is the first step in the process. Ensure the patient first has a dentist, and second be sure they are making regular 6-month appointments, and if they have issues with dental health, they should be going for cleanings as often as every 3 months. Oral hygiene is the foundation for the remainder of the interventions.

Gum, Candy, and Pilocarpine

Most patients are told to carry a bottle of water around and take frequent sips throughout the day. This does not work. It provides temporary relief, and does not address the underlying issue. You can educate the patient about drinking more water while eating which can help facilitate the swallowing process especially when dry mouth is an issue. Carrying a cup of ice can be helpful but is not convenient. What I prefer is the use of sugarless gum or candy which can be easily carried and chewed as needed. Studies have demonstrated that xylitol containing gum can reduce the levels of Mutans streptococci and lactobacilli in saliva and plaque. This has the potential to reduce the incidence of dental caries, and is an inexpensive option for most patients. I will also recommend as a second line using a mouth wash for dry mouth such as Biotene. If these interventions are not effective a medication to stimulate saliva production such as pilocarpine. In many cases pilocarpine eye drops which act locally is a better option than a medication that acts systemically. 

Final Words

Dry mouth is a common side effect patent’s experience but may not always bring to the clinician’s attention. There are interventions to treat this side effect that range from simple interventions like xylitol containing gum to pharmacological interventions such as pilocarpine eye drops. Most patients will experience relief with the above treatments. This highlights the importance of asking about specific side effects so they can be treated early and prevent long term Complications such as tooth loss. 

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