Advanced Technology Solutions for the Treatment of a Variety of Brain Disorders [Interview][Transcript]

Dr_Aron_Tendler_BrainswayGuest: Dr. Aron Tendler
Presenter: Neal Howard
Guest Bio: Dr. Aron Tendler, MD, is Chief Medical Officer at Brainsway. Dr. Tendler graduated in 2002 from State University of New York Downstate Medical School in Brooklyn with Distinction in Research. From 2002-2004, he trained at Tulane University in Internal Medicine and Psychiatry followed by two years at the University of Chicago in General Psychiatry.

Segment overview: Dr. Aron Tendler discusses Brainsway’s Deep TMS (Transcranial Magnetic Stimulation) therapy that has been cleared by the FDA for treatment of patients suffering from Major Depressive Disorder who have not responded to standard medication treatments.

Transcription
Health Professional Radio – Treatment for Brain Disorders

Neal Howard: Hello and welcome to the program, I’m your host Neal Howard on this Health Supplier Segment here on Health Professional Radio. Depression is one of the most misunderstood and debilitating of mental conditions, the symptoms ranging from mild to severe with potentially very, very dangerous effects on sufferers. Our guest in studio today is Dr. Aron Tendler, Chief Medical Officer at Brainsway and he’s here to discuss Brainsway’s deep TMS. How are you this afternoon and welcome to Health Professional Radio Dr. Tendler?

Dr. Aron Tendler: I’m doing well, thank you.

N: Thank you. What exactly is a Brainsway? Talk a bit about your background and how you fit in with Brainsway?

T: My background is I’m a board certified Psychiatrist and I finished my training in 2006. I was in private practice and doing some clinical research with patients with … depression, doing some interventional approaches in treating people that failed treatments and medications and after doing that for several years I joined the company as their Chief Medical Officer. Brainsway is a manufacturer and patent holder and inventor for a technology called Deep Transcranial Magnetic Stimulation. They make a device, several devices but they make one FDA cleared device that emits magnetic pulses to specific areas in the brain that are affected in people that have depression and by targeting those areas we’re able to hopefully renormalize and effectively treat patients who have not benefited from medications to treat their depression.

N: Now, the symptoms of depression range as I said from mild to severe, are there ever instances when someone is diagnosed as having a mild to moderate form of depression that is still resistant or is this resistant depression always a severe form?

T: So depression is the chronic illness for most people that get it, a chronic recurring illness for most people that get it. In fact about 17% of Americans will get depression in their lifetime and for most of those people it’ll be something that they’ll get and then probably get again and probably get again and get again and for some people it’ll be chronic. The reason why I’m bringing that up is because at various points in time it’ll vary in its severity. So at some point in time a person may have a severe depression in which they may have thoughts or even attempts to end their lives or thoughts of rather be dead and inability to function at work and sometimes it may be mild where they’re just not getting the pleasure out of things but they’re essentially functioning normally and other times maybe moderate. But the bottom line is that when depression is treatment resistant meaning it’s not responding to one or more medications typically, two medications is what we typically call treatment resistant depression, a patient who has it is typically going to have a relapse. In fact the frequency or how soon the relapse is going to come on actually can be predicted by the number of residual symptoms the person has. So if I treat a patient for depression and depression has 9 symptoms and if you have 5 out of the 9 symptoms you’re considered to have what we consider major depressive episode. But once I treat the person and they’re better but they still have difficulty in concentration and they still have some difficulty with sleep but they don’t have, they’re getting pleasure out of activities and their appetite’s normal and they’re not crying and they don’t have thoughts of death and they don’t have guilt, they don’t have feelings of worthlessness but they still have those two symptoms, they’re more likely to have a relapse within six months versus someone who have no symptoms.

N: How does Brainsway educate the patient on the advantages or maybe some of the disadvantages that may be associated with this newly FDA approved non-traditional treatment for major depression?

T: So for people that have depression, whatever the cause of the depression, so the depression as I mentioned people would have at least 5 out of the 9 symptoms so sadness, cheerfulness or lack of pleasure and changes in their energy and motivation, whether that came after some sort of problems with the relationship or a job or some sort of a trauma but if someone has those symptoms and they last for more than 2 weeks and again whether there was some event that initiated it or… if they have a major depression the changes that occur in the brain are all the same. The brain doesn’t really distinguish between those two and the treatments that we have for depression they fall into several categories. They fall into category of medications, they fall into category of psychotherapy and they fall into category of brain stimulation treatments, non-pharmacologic brain stimulation treatments and treatment resistant depression means that the patient has failed one or more, typically we consider two but one or more medications. And I mentioned earlier that about one in six about 17% or so of Americans will have depression in their lifetime and 52% of them will fail one medication and 32% of those people will fail four medications. So medications are considered to be the normal course of treatment for depression but out of those 16% of Americans, we’re talking about 32% of them are not getting better from the medications that we give them and those are anti-depressants. So as far as treatment resistant depression which should be anywhere from 52 failing one medication to 32 failing any medications, you can give them medications that are not typically considered anti-depressants such as anti-psychotics. If you add an anti-psychotic to an anti-depressant that’s one technique. Other things people do work – psychotherapy, psychotherapy … help more than medications do but sometimes combining psychotherapy with medication can help some people. And the other approach is brain stimulation and what’s available out there is part of brain stimulation, the gold standard for treatment with resistant depression is something called electroconvulsive therapy. Electroconvulsive therapy also known as shock therapy or ECT that has the best treatment efficacy for people who have treatment resistant depression. Now there are some disadvantages to various treatments so for example adding an anti-psychotic to the anti-depressants but the disadvantage is that there’s easily significant side effects with those medications usually weight gain is what I’m thinking about sometimes diabetes but primarily that’s a disadvantage going on to that medication – it doesn’t mean it’s not a good approach to try. Psychotherapy it doesn’t have tremendously high rates of people getting better. It’s not been considered a gold standard kind of treatment for people who have treatment resistant depression but it’s something you typically try in people who failed medication or even people who haven’t tried medication yet. As far as electroconvulsive therapy which is the gold standard treatment most people don’t want to try that, unless it’s really the last line of treatment because it has a lot of cognitive side effects. People have a lot of memory loss and they can’t drive for 6 weeks around the treatment, they had to be driven to treatment and back and every time you go you have to undergo anesthesia and then you’re given a seizure and then someone takes you back so it’s not the normal course of treatment. That’s where a transcranial magnetic stimulation comes in, you go to the treatment and you go specifically into the doctor’s office, the doctor has a machine and specifically with deep transcranial magnetic stimulation which is what Brainsway provides, you’re basically sitting on a chair and a helmet is placed on your head and you feel a tapping sensation for 20 minutes and the side effect that’s most common is the temporary headache during the treatment and the rare side effect that’s risky if people get a rare case, there’s a rare incidence of getting a seizure during the treatment. Similar to the risk of getting a seizure for example if you’re taking an anti-psychotic or if you’re taking some medication combinations, so it’s pretty rare but they don’t cause any cognitive side effects, no memory loss and you drive yourself to the doctor and you drive home and you do it 5 days a week. Typically for somewhere between 4 and 6 weeks, you may need some more treatments after that and you actually have no weight gain or sexual side effects, no diabetes, no cholesterol, you could do it being with any medications and the only contraindication and only thing that you can’t, that prevents you from getting this treatment is that if you have any magnetic material in the skull. So someone for some reason had surgery that puts some magnetic material in the head and you can’ get for example an MRI of the brain you also can’t get this transcranial magnetic stimulation treatment for depression.

N: So some of the side effects are similar to what you call shock treatments but they’re very rare. Is there any, is this low level electricity, is there any electricity involved at all?

T: So it’s an excellent question, so with shock therapy you provide actual direct electricity to the skin and the scalp and thus to the actual brain and you induce a seizure. So the way shock therapy works is you cause the patient to have at least a 30 second seizure every time they come in and you do shock therapy 3 times a week. They’re typically for 12 -16 treatments that’s how shock therapy works, you’re giving the patient a seizure 3 times a week and in shock therapy because you don’t want the person to shake and bang their hands and injure themselves, you give them anesthesia and you paralyze them so it’s actually kind of, it looks pretty pleasant and it doesn’t look like the person’s having a seizure because… they’re asleep and they’re getting some sort of minor twitch. You don’t see into that but because you’re giving them a seizure it causes cognitive side effects, it causes some memory loss and people don’t remember anything around that period of time and then they’re not supposed to sign any contracts and they can’t drive for about 6 weeks because you’re giving them frequent seizures. With transcranial magnetic stimulation, we’re not applying direct electricity to the skull or the skin so there’s no discomfort there, what we’re doing is we’re inducing an electric activity in the neurons by applying magnetic pulses and magnetic pulses using… can induce a current in a conductor which are neurons so we’re inducing a focal current in a small area of the brain, a small area of the brain without inducing a generalized seizure but what can happen in rare cases is it can generalize and the person can get a seizure which is what I mentioned, there is a rare risk of the seizure, not common. And the side effects are not the same that’s why there’s no cognitive side effects with transcranial magnetic stimulation, you don’t have memory loss with transcranial magnetic stimulation, you drive yourself there and back etc.

N: So an answer to my question, there is electricity involved but it’s the brain’s own electrical currents that are stimulated into firing not anything outside this being introduced into the brain via the skin?

T: So we’re not applying, yes we are applying, we are inducing a current, we’re inducing electricity in the brain in a focal area in the brain as opposed by applying magnetic pulses. We are not applying direct electricity, I guess the best way to think about it is you’re applying focal electricity to a small area of the brain as opposed to causing generalized electrical activity in the whole brain which is what ECT does.

N: Now that’s quite a bit of information especially to someone who maybe suffering from the very depression that you’re treating. How does Brainsway reconcile the lack of knowledge of the patient as to all of these options and side effects or lack thereof in order to better help the patient? Do you have a staff that is dedicated to educating the patient or is the practitioner solely responsible for each patient?

T: So in reality what we do is we have the answers to some of these questions but we really train the people who get our devices which are the practitioners and we try to provide for them with very specific literature to educate their patients because it’s very important that when a patient comes that they’re fully provided with all their options. That’s part of getting an informed consent and it’s whenever a patient undergoes any procedure or any treatment they have to be aware of what else is out there and that’s part of the practitioner who offers the treatment, part of their job as the physician to present the information in a clear way that make sense in a not confusing way and in a way that convinces the patient of what the practitioner thinks is logical, not confusing.

N: Now is this has been recently approved by the FDA am I correct in that assumption, maybe in the last two years or so?

T: So it’s approved of January 2013, just over like two and a half years ago and it’s been very well accepted. There are about 140, I’m not a hundred percent sure exactly but on our website you can see on brainsway.com you can see, you can find a provider, so there about a hundred and forty locations in United States that provide it and basically patients can also go to the website and they can see more information and videos showing interviews of the patients or showing the device and what it’s like and there’s some information on there as well and publications etc.

N: Thank you so much for joining us here on the program today. You’ve been listening to Health Professional Radio, I’m your host Neal Howard for this Health Supplier Segment. Our guest has been Dr. Aron Tendler, Chief Medical Officer at Brainsway, talking about Brainsway’s Deep TMS or Transcranial Magnetic Stimulation therapy. We’ve been talking about what TMS is, when it’s considered as a treatment option and also direct our listeners to a website where you can get more information about TMS and Brainsway. It’s been a pleasure speaking with you this afternoon Dr. Tendler.

T: Thank you Neal.

N: Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm and you can subscribe to this podcast on iTunes.

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