The Science Behind the Best in Class Outcomes in Mental Health*

*according to Validation Institute and Al Lewis

One of my jobs is building the future of mental healthcare¹. One of the places at which I do that is Acacia Mental Health. This program just got a remarkable stamp of approval.

The gold standard for “not a scam” in health benefits vendors is Validation Institute. Al Lewis, the author of the book on savings in healthcare, will very rarely also put a personal guarantee on a healthcare company. He puts money on the line—if you can disprove his math! They both Validated Acacia’s BRAIN protocol for both best in class outcomes and savings, and put $50,000 and $100,000 bets on their math, respectively.²

The science behind how Acacia was awarded the first “Program Level” validation for a mental health solution is what follows…

Transcranial Magnetic Stimulation, or TMS, is teaching your brain how to suffer less.

The treatment uses a pattern of mild stimulation that passes harmlessly through the scalp, skull, and into the brain. There, it causes neurons to fire in that new pattern.

The mechanism of change is learning. Just like learning anything new. With a flashcard, you look once, and look again in an hour, and then maybe again in another hour. With that spacing, you reinforce what you learned.

Accelerated transcranial magnetic stimulation does the same thing. With TMS—using the right pattern—for about eight and a half minutes, every hour, with 50 minutes in between, you learn how to be…not depressed. This allows more rapid remission.

TMS treatment uses Michael Faraday's law of electromagnetic induction. Yes, from the 1800s:

Point the thumb in the direction of the wire, the fingers curl in the direction of the magnetic field, and the current is induced in the wire.

It’s the same for the wires that are the neurons in your brain.

By changing the pattern of stimulation, we act like a conductor for an orchestra.

The rhythm we create with TMS is our conductor. It allows your brain to “play together” in a synchronized rhythm—it leads to feeling well. The brain's natural language is rhythm. Thus, the rhythm we use is crucially important.

The spacing between those rhythms also creates sustained changes in brain functioning. That is why we use a 50 minute pause between treatments. It’s “diligent practice,” just like a great rock band—not a weekend warrior bar band. I am not hating on bar bands—but practicing rarely isn’t the way to prepare for the big shows in life.

The side effect profile for transcranial magnetic stimulation is mild. During the course of treatment, you can feel fatigue, headache, jaw pain, because we're making the neurons in your scalp fire, and that can make your jaw move.

It can cause headache. There can be some scalp tenderness— the coil actually creates a sensation on the surface of the scalp. That can be uncomfortable— or even a little bit painful at first—depending on your “motor threshold.”

We measure “motor threshold” every single day. It is how we calibrate the energy we're using to stimulate your brain. If this was a medication, It would be the dosage, and it's customized to you.

The first step in TMS treatment is brain mapping. We're moving around the coil—sometimes that's a helmet, sometimes it's a figure of eight coil—and we're finding just the right spot that can make your thumb move, or your foot:

And we use the threshold, which is half of the time your thumb or your foot moves, depending on the placement, to calibrate. The right energy, and that's called the motor threshold (MT), because it's making movement from your motor cortex half the time. We measure the right energy every day. Next, after we've found the right spot with functional brain mapping, and the right measurement for the dosage, then we can give a targeted treatment.

The treatment is repeated pulses of energy, and in theta burst stimulation, that pattern is triplets.

That pattern at 50 Hertz cycling five times every second with pauses in between, it turns out that's the same natural rhythm of the brain. We learned that by measuring neurons firing in the hippocampus, which is the mesery. We learned that from measuring neurons hippocampus of a brain. We give that same pattern back to the brain.

In this video, I made to help train my team on alternate coil placements, I get a touch of “theta burst” treatment to the right side of the brain:

Theta burst, we call it, because it used 5 hertz —the greek letter corresponding is theta—burst (all at once), thus “theta burst.” So we give that to pattern for 8.5 minutes total, each cluster of 50 hz at a 5 hz cycle, with 7 seconds in between, and then we pause for 50 minutes.

This is the a natural rhythm for the brain to resynchronize with itself. It was measured from the hippocampus of the brain itself!

The problem with depression or OCD isn't having the wrong brain or feelings; it's being out of sync with ourself.

You don't make a concert better by replacing all the instruments— instead of tuning and practice. Similarly, you don't make your feelings better without practice and proper intonation of your brain. The practice your brain needs is this pattern, and the right location is our tuner. But trying to do endless therapies that are unlikely to work is a little bit like trying to have a great concert without allowing anybody to tune the instruments appropriately. Practice all you want, it'll still sound like crap without a tuner!

The effects of TMS from accelerated treatment can be noticed by some sooner than others. At the end of five days of treatment, many people will have a full remission of their symptoms. The less guarded term for this is “not depressed.” No one likes the word cure since it was jacked by snake oil sales people.

Some people's brains are less “Acceleratable”— you can't hurry them up. For those individuals, after five days of accelerated tms treatment: seven days later, a group of people³ will be in remission. Thee weeks after that⁴, there's another group of people⁵ who are in remission of their symptoms of depression.

That means depression is over— not 50% better.⁶

And by the end of a course of accelerated TMS for depression (as productized by magnus medical):

79% of people have remission of their depression symptoms in the one study.

A fair question is how long is this going to last?⁷ “A while” is a glib answer. Active research is afoot!⁸

Some people benefit from treatment more frequently; some people can wait and get a re-treatment in a year or so. It's safe, causes no permanent changes in brain functioning, and is effective. It doesn't require any medications⁹.

One of the things that we don't know yet is how much TMS is the right amount for anybody. And historically, I believe the research suggests we've underdosed the treatment.

More is (more or less) better. “More” can mean more treatments, or over more time. And so for some people, after that accelerated course, sometimes we continue twice a week for up to 12 weeks to get to full remission.

“Targeting” for TMS is an important concern. Based on what you tell your doctor and the information we have in the medical history, we use our judgment—doctors call this clinical decision making—to work out:

Where is the most likely treatment for your depression or your worry? And then target it using either:

1. A figure if 8 coil

2. An H coil systems, which looks like a giant helmet.¹⁰

3. 10%

4. “figure 8” coil, in our group at Acacia, we target using an fMRI, or Functional Magnetic Resonance Imaging. That that coil is more focal, it only targets a tiny area of the brain, about a cubic centimeter; we need to ensure we're hitting the right spot.

We use an MRI scanner to find the right spot based on your brain talking to itself.

Looking at those relationships—based on blood flow changes over time—between the “depression target” and the rest, we find exactly the right spot for your depression, or your obsession, or your trauma.

And that's the strategy with transcranial magnetic stimulation. We have all the tools— H coil systems, which use a larger array in a helmet, neuro-navigation, figure eight precision stimulation, and the ability to select the right target functional magnetic resonance imaging when we need.¹¹

Thanks for reading, welcome to the future of mental health.

If you are looking for the best mental health services for your company—according to Al Lewis!—email owen@acaciaclinics.com.

1. Ok, that is all of what I do.

2. Yes, of course I am an author on much of that published research. You thought I just wrote newsletters?!

3. about 10% more

4. four weeks after concluding treatment,

5. about 10%

6. the standard we used for clinical trials of medications.

7. We understand the durability is personal and variable, but on average, it's between 12 and 18 months.

8. I will note we don't expect dialysis to last forever either, we except that saving your life in a way that we have to repeat is something that's worth doing if it works well enough to prevent you from death.

9. Obsessive-compulsive disorder can also be treated with TMS— we use a different target in the brain.

10. We have the H1 in depression and anxious depression, and the H7 coil, originally FDA-cleared in OCD. It has been subsequently approved for depression. The first brain stimulation treatment for addiction is the H4 coil, which we use for smoking cessation and may work for other indications.

11. I wouldn’t be a doctor if I didn’t talk about side effects…

The only permanent side effect we know of from TMS is tinnitus. That's ringing in the ears. That can happen because the noise can be very loud. And so for some people... or treated at a higher power, we use earplugs. So you protect your hearing and don't have a problem.

Another rare side effect, at worst one out of about 30,000 treatments, is a seizure. The seizure is induced if it occurs.

It doesn't mean you have epilepsy, but it's an extremely rare side effect. It's about two orders of magnitude less than the risk of seizure with something like Welbutrin or Prozac.

The difference is, with those treatments, you might have that seizure anywhere, and here it would be happening right in front of... The team is in the doctor's office and only lasts as long as it takes to hit the stop button, and maybe a few moments after.

We've seen this adverse effect happen previously and there has been no permanent long-lasting harm from that rare adverse effect in out experience.