Depression treatment with MagVita TMS Therapy

Dr. Stubbeman, TMS Psychiatry

Dr William Stubbeman

“All of our patients who have reached remission with TMS were previously severely refractory,” says Dr. Bill Stubbeman.

With a remission rate of 80%, Dr. Bill Stubbeman’s clinic attracts patients from across the USA, Japan and Canada who have struggled with depression for years. Stubbeman hopes that Theta Burst treatment in combination with neuronavigation will one day become the standard of care instead of the currently used protocols.

At his psychiatric clinic in West Los Angeles, Dr. Bill Stubbeman is treating patients suffering from refractory major depression. Five years ago he began offering TMS treatment at his practice after having extensively researched TMS and felt that it was the future of psychiatry practice. His patients have typically had a lifetime struggle with depression and have failed to receive benefits from medication or even Electroconvulsive Therapy.

“We have an 80% remission rate using a high frequency protocol combined with neuronavigation. All of our patients who have reached remission with TMS were previously severely refractory,” explains Dr. Stubbeman. Usually the patients find his clinic after having well-researched TMS and neuronavigation, but he also gets referrals from colleagues who have been unable to bring their patients to remission. “Many of my patients are skeptical when they first come to my clinic because nothing else has worked for them. Luckily, TMS has a low placebo effect, yet high remission rate. Education about TMS and attentive care allow patients to better evaluate TMS results. When nearing the end of treatment, all patients are generally amazed that the results are unbelievable yet real, and they hope that it lasts,” says Dr. Stubbeman who is afforded a lot of gratitude by patients finally in remission who are very appreciative of their treatment results.

A great day at the office

“When current patients are in remission or moving toward remission, that is a good day. When TMS is a known option for those who are not getting medication benefits, and they are in my office getting well, that’s a great day,” says Bill Stubbeman who is motivated by the fact that he is able to help people who have failed all other treatments get their lives back. Unfortunately TMS is not that well-known among psychiatrists. “It is my impression that most psychiatrists in the USA are not very familiar with TMS and its high potential for treating patients who have failed everything else. Gradually, TMS is becoming more known to the general public through word of mouth and it is being covered on more and more insurance policies,” says Dr. Stubbeman.

An expensive treatment, but…

The price for a TMS treatment remains the Achilles’ heel for many patients, but according to Dr. Stubbeman it is also necessary to take into account the long term cost of psychiatric care, including therapy, medications, hospitalization, and loss of work days when the price is evaluated. “When all this is taken into account, the total cost of TMS treatment becomes relatively low. We also emphasize the cost of depression on relationships and the joy of living. All of our patients are private patients at the moment, but given the high rate of remission we have had, we wish to offer this treatment to as many depressed patients as possible, including those who are unable to afford the treatment themselves. In the near future, we are planning to work directly with insurance carriers who support TMS,” says Dr. Stubbeman.

More suppliers, more competition, lower prices

MagVenture’s recent FDA clearance of the MagVita TMS Therapy brings the number of FDA cleared TMS devices for depression treatment up to four. According to Dr. Stubbeman this is likely to make TMS available to a greater number of people. “Every new FDA clearance creates some level of noise in the ears of the public, medical and health insurance entities. Competition for the same technology drives down costs and thus makes it more available to physicians with TMS becoming available to a greater number of people – but unique and clinically effective treatments provide the value to warrant higher reimbursements,” stresses Stubbeman.

The future of TMS

According to Dr. Stubbeman the future of TMS depression treatment lies not in the rTMS protocol currently in use, but rather in Theta Burst stimulation. “I think that the future of TMS is in patterned treatment protocols like Theta Burst, and MagVenture’s TMS devices have much greater flexibility than other devices on the market. This should allow for higher remission  in the US. I hope that someday 20Hz Theta Burst treatment will become the standard of care because in my experience, this works much better than the protocols currently used. Theta burst is arguably both safer as it uses lower intensity, and more tolerable with less total time per treatment than conventional TMS. This would allow even more patients to benefit from TMS treatment,” says Dr. Stubbeman who encourages doctors to use TMS in combination with neuronavigation.

“In the future, I hope to convince more doctors to use MRi-guided neuronavigation for precision targeting as well as take weekly motor threshold measurements on the patient using EMG electrode to accurately account for fluctuations,” ends Dr. Stubbeman, of his hopes for the future of TMS depression treatment.

William Stubbeman, MD

Dr. Stubbeman graduated with high honors from Princeton with a degree
in Mechanical and Aerospace Engineering and received his MD
from Columbia University. He began his training at UCLA as an Ear,
Nose and Throat Surgeon specializing in auditory pathology, but his
growing interest in the brain caused him to switch focus to psychiatry.
He subsequently built a private psychiatry practice in West Los Angeles
specializing in treatment-refractory psychopharmacology.
After realizing the potential of TMS to help patients that were
beyond the reach of medication, he changed the focus of his
practice to TMS treatment.
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Medical University of South Carolina: 10 questions for Dr. Mark George at the Brain Stimulation Laboratory

1) How did you first become involved in TMS?
Dr. Mark George

Mark George, who is here seen during a well-attended TMS workshop at the 12th World Congress Of Biological Psychiatry in June 2015 in Greece, has worked with TMS for almost three decades. He finds that there is “still a lot to work on” but remains confident that TMS for treating depression can and will continuously be refined and improved.

I first encountered TMS when I was doing a research fellowship in 1989 at University College London. I was doing brain imaging with PET and SPECT, and was interested in the  brain regions involved in regulating emotion. When I saw John Rothwell [professor of neurophysiology at the Institute of Neurology at Queen Square, ed.] using TMS in his motor  lab to study the motor system, I immediately wondered if we could use it to investigate brain circuits involved in emotion regulation, and perhaps even treat diseases like depression.

2) For you personally, what was your main reason for choosing to work with TMS?

Imaging alone was insufficient. Brain activity during a task or state could be due to the task or state, or could be the brain’s reaction to the core activity, or could be merely incidental.  TMS seemed to offer a way to push and pull circuits and test out causality. And maybe if we were lucky, and we are, actually treat brain diseases that involve dysfunction in these circuits.

3) How was TMS perceived in the ‘early days’?

Back then all of these ideas were heretical – regional neuroanatomy of depression, brain basis of emotion egulation, non-invasively and without causing a seizure stimulating someone out of depression. I later did the first clinical work at the National Institutes of Health (NIH) in Washington, with Dr. Robert Post. The going was still rough as there was much skepticism – getting asked to leave an ECT meeting, and having my senior boss at the NIMH tell me I could not talk to the press about TMS as they did not want to ‘sully the NIH name.’

4) Seen in the infamous hindsight, what would have been especially nice to know back then?

The FDA was concerned about TMS causing a seizure and the potential effects of lots of pulses. They thus limited our early studies in terms of the intensity of stimulation. We underestimated the number of pulses needed, and the number of weeks we needed to stimulate. I wish we had been more aggressive in pushing the parameters of stimulation. I think we underdosed for well over a decade, and may be still underdosing.

5) What do you consider to be among the most profound discoveries made?

That it worked is truly amazing. We did double blind studies from the beginning, but I was always worried that the effects were not going to replicate for whatever reason. I was very pleased when Dr. Saxby Pridmore, whom I had never met and who was working in Tasmania, Australia, started replicating our results, and showing changes in a biomarker called the dexamethosone suppression test (DST) [DST is used to assess adrenal gland function by measuring how cortisol levels change in response to an injection of dexamethasone. In conditions such as depression, dexamethasone can prevent cortisol levels from going down, ed.].

6) Even though we are seeing very promising results, there are still some patients with MDD whose condition does not improve with TMS. Will it be possible for more patients to respond positively to the treatment?

I am an optimist. I am confident that we can and will continue to refine and improve TMS for treating depression, at least approaching the efficacy of ECT (60% remission). There are lots of candidate clues for improvement. It is important to remember that many of the methods we use now for treating depression were educated guesses that have not been fully explored. These involve total dose (number of stimuli), different dosing regimens (multiple daily rather than once daily), frequency matching to the individual, or frequencies like theta burst that may be more powerful at changing the brain, better targeting, or combining TMS with talking therapy or special medications. There is still a lot to work on. It would be unbelievable if our educated
guesses turned out to be the best solutions.

7) What, within the field of TMS research for the treatment of MDD, do you consider to be among the biggest challenges you are facing today?

TMS for treating depression, as we do it now, is terribly inefficient, requiring many hours in the TMS chair. We need to figure out how to reduce this inefficiency and thus make it less  costly, both to patients, doctors, and insurers. Wouldn’t it be great if we could get 70% remission with only a few hours work?

8) With MagVenture’s recent FDA clearance for depression treatment, four FDA cleared systems are now available. What impact will this have in the US?

I think this is all good news. A rising tide floats all boats and we have lots of boats now. This means that not only one manufacturer has to do battle with insurance companies, but we now have a larger industry to fight these battles. I think this competition will drive down costs and spur competition and innovation.

9) Do you expect to see many new TMS treatments emerging in the next 10 years or so? Where do you see the most potential in terms of treatment?

There are lots of studies with TMS in almost every major brain disease. Some of the more promising areas currently are acute or chronic migraine, pain (either post-surgical or chronic), OCD, PTSD and addictions.

10) Can you tell a little about your current study with the U.S. Department of Veterans Affairs (VA)?

Cooperative Study Protocol #556 is chaired by Dr. Jerry Yesavage at the Stanford VA and designed to test whether prefrontal TMS works to treat depression in veterans. It is thus more ‘realistic’ than the pivotal NIH, Neuronetics and Brainsway trials, which were antidepressant medication free studies in patients without substantial comorbidities. The VA trial allows patients to stay on their medications, and many of them have PTSD and prior substance abuse. MagVenture won the competitive bid for the TMS device. We hope to complete enrollment in the late spring of 2016.

Dr. Mark George

Dr. Mark George received his medical degree from the Medical University
of South Carolina in Charleston.  He was a Visiting Research Fellow
at the Institute of Neurology, University  College London, England.
At the National Institute of Mental  Health (NIMH) he was among the
first to work with functional imaging  which led to his pioneering use of
TMS. Since then, he has worked continuously to grow the science of
TMS.  In 1995 he moved back to Charleston and built the functional neuroimaging
division and brain stimulation laboratories, now known as the MUSC
Center for Advanced Imaging Research. In 2008, with the academic publishing
company Elsevier, Dr. George launched the journal Brain Stimulation:
Basic, Translational and Clinical Research in Neuromodulation, of
which he is also the editor-in-chief.
Dr. Mark George has received numerous awards, and published over 400
scientific articles or book chapters.