Since he first began to offer TMS in 2013, Dr. Lane Cook has helped a large number of patients beat their severe depression. By the time of their referral, they have already failed many antidepressants and/or psychotherapy.
At the Knoxville-based clinic, however, the majority of these patients find new hope: 50% achieve full remission whereas 66-70% achieve response (at least a 50% reduction in depression rating scales). “By the time our patients need TMS they are fairly discouraged and they meet us with a mixture of hopefulness and hopelessness,” says Dr. Cook. He gets half of his referrals from fellow local psychiatrists who have exhausted their medication and psychotherapy trials for treatment resistant depressed patients. The patients usually do not have any reservations about trying the treatment, except one big fear: that it won’t work. An important part of the job for Dr. Cook and his staff is therefore to provide encouragement to the patients: “We tell them how easy the treatment is, that TMS will feel like a woodpecker on the head [from the tapping of the magnetic pulses on the head, ed.] but typically without any pain,” he says.
A 50% full remission and 66-70% response rate among these, until now, treatment-resistant severely depressed patients, would by many healthcare providers be seen as astounding results. To Dr. Cook, however, the numbers are not all that
surprising, having been told “years ago” from a friend that her results with TMS were much better than what had previously been published.
“The early studies of TMS were done in patients taken off antidepressants and the protocols were not fully maximized to their potential,” reports Dr. Cook. Consumable costs top priority Dr. Cook was among the first to offer MagVita TMS Therapy in the US shortly after it received FDA clearance in 2015. According to Dr. Cook, there are several issues to consider when choosing TMS equipment, with consumable costs ranking the top of his priority list. “High consumable costs are not cost-effective and in some states in the US, insurance reimbursement is actually less than the cost of consumables,” he explains.
“We were paying as much to operate our first device to the manufacturer in one year as it cost to purchase the MagVita,” Dr. Cook explained. “In addition, the chair, the neck rest, and the cooled coil are more comfortable, quieter and the experience for patients who have tried earlier TMS devices is much more acceptable.”
Easier to get reimbursement
Most insurance companies have specific criteria that the patient must meet before being eligible for TMS.
Typically the patient must have failed 4 antidepressants with or without psychotherapy. However, problems of getting reimbursement from health insurance companies are now – more and more – a thing of the past, according to Dr. Cook, who finds it increasingly easy to obtain reimbursement, especially from companies he is already in network with.
As far as the others, “you can always do single case agreements,” he says. This change of tides among the insurance companies also makes it easier for the patients who no longer have to pay up front for the treatment. Most insurance companies require reasonable copay.
Spreading awareness of TMS
The advantage of having a TMS practice as opposed to a typical psychiatric practice also pertains to the logistics: In a TMS practice, the psychiatrist only has to be present in the initial motor threshold or repeat MT, Dr. Cook explains. From there
on, the technician/coordinator usually does the rest. His office manager handles the paper work, and has, for instance, solid expertise within insurance issues. This enables Dr. Cook to take time out of his busy work schedule to further spread awareness of TMS to help ensure that more people can get the help they need. It is, for instance, necessary that “more primary care physicians become aware of this excellent treatment resource,” he stresses. Dr. Cook has given CME (Continuing Medical Education) talks on TMS, as well as several discussions for the public. He finds that both are good ways “to get the word out and help people grasp the concept of how this is different from psychotropic meds.”
Helpful peer and mentor network
Training as well as a peer and mentor network are also important factors. Dr. Lane Cook has participated in advanced TMS courses, something which is even a requirement by some insurance companies – and finds it extremely valuable to be able to get advice from renowned researchers at Duke or Harvard University. He completed advanced training at Medical
University of South Carolina with Dr. Mark George who is widely considered as one of the founding fathers of TMS for depression. He enjoys being able to occasionally consult with Dr. George on TMS matters.
Hope for more indications
As for the future, Dr. Cook is confident that the future of TMS for the treatment of depression is “very bright” and furthermore hopes for an FDA clearance of Theta Burst TMS for rapid treatment of Major Depressive Disorder. Further down the line, Dr. Cook also hopes “that with research we can help more people, suffering for instance from Panic Disorder, Bipolar Depression, Generalized Anxiety Disorder, and PTSD.”
Dr. Lane M. Cook
Lane Cook, M.D., received his board-certification to practice psychiatry in 1981 and has been practicing in Knoxville, Tennessee, ever since. He is the owner as well as Chief Medical Officer of TMS of Knoxville, LCC. The clinic first began to offer TMS for the treatment of depression in 2013 and has since then treated more than 85 patients.
Lane Cook was appointed Assistant Professor of Psychiatry at both the Baylor College of Medicine as well as the University of Tennessee in 1981 and 1983, respectively.
Dr. Cook is a well-known clinician and a frequent lecturer around the Southeastern part of the US. He has given CME lectures as well as talks on TMS to the local National Association for Mental Illness and a mental health coalition group.
35 years ago, Robert McMullen, MD opened his private practice in general psychiatry on the West Side of New York City. In 2010, he added
TMS depression treatment to his long list of treatments. Being a psychiatrist, Dr. Robert McMullen found himself looking for a way to treat his many patients suffering from major depressive disorder who did not respond to the medication he prescribed to them. To Dr. McMullen, TMS was the solution. “I was first interested in TMS because I had been reading about its benefits for years, and I needed an alternative for the many patients who failed to achieve full remission from antidepressants,” says Robert Mc-Mullen of his decision to finally invest in TMS equipment to make the – at the time – novel treatment available to his many patients.
No per-use fee
“The purchase price of the TMS equipment that I first bought was very expensive, and it has actually cost me a lot of money that I had to pay a fee to the company for every treatment I did. I am therefore very pleased that it is now possible to get FDA cleared TMS equipment from other manufacturers such as MagVenture who do not operate with a ‘per-use fee’. That makes a big difference to me and my practice,” says Robert McMullen.
TMS is worth travelling for
So far, around 300 patients with major depressive disorder have undergone TMS treatment at TMS BrainCare. “What has sustained us has been the enormous benefits, as well as long acting benefits, for so many of my patients,” says Robert McMullen, who in the past five years since he first began to offer TMS has been treating men and women of all ages from all over New York City and even further away.
MD Robert McMullen graduated from Georgetown University
Medical School in Washington DC in 1976.
He is founder and owner of TMS BrainCare in New York.
For 35 years he has had a private practice in general
psychiatry. He treats patients with a wide range of mental
illnesses. He specializes in the treatment of mood disorders
and anxiety disorders and is particularly experienced
with the treatment of resistant depression.
In 2010, he began offering TMS treatment.
More information at: www.tmsbraincare.com
Dr. John O’Reardon, Professor of Psychiatry at Rowan University and noted researcher of neuromodulation techniques, welcomes the FDA clearance of MagVenture’s MagVita TMS Therapy system for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
In July 2015, MagVenture was the fourth and thus the latest TMS manufacturer to receive an FDA clearance. Dr. John O’Reardon, who has extensive research experience within the field of TMS, sees this as a positive development, both from the perspective of a researcher and a clinician. He believes that the clearance will not only provide a healthy competition to the market, but will also further encourage insurance companies to provide meaningful reimbursement for the procedure.
On a global scale, John O´Reardon believes that the FDA clearance could also impact the dissemination of the TMS technology, both within clinical practice as well as in research. “More psychiatrists will start doing TMS and when good clinical results are observed this will create a strong word of mouth effect which will also encourage research specific to this particular device,” he says.
Potential pricing advantages, reliable cooling and low noise
John O´Reardon has been using MagVenture’s TMS equipment for the past 7 years. “From a psychiatrist’s point of view, MagVenture has some advantages,” he explains. “There are no extra costs for disposables. This will encourage other psychiatrists sitting on the sidelines to get into the marketplace. Furthermore, the cooling system has been very effective and reliable. It never overheats. The operator places the magnet directly on the scalp thus having a lot of freedom of movement in placing it accurately. Since everybody’s skull is shaped differently this is helpful. The noise level is reasonable. Also there has been little in the way of technical glitches, in my experience. It is important not to have these problems as you have a patient standing there waiting for treatment. The last thing you want is not to be able to do the session,” John O´Reardon stresses.
ECT research led to TMS interest
John O´Reardon’s interest in TMS emerged in the mid 90’s while doing a fellowship in Psychopharmacology and administering ECT. He read a report in Neuro Report which described the treatment of 6 patients using a new technology called TMS written by Mark George MD [see interview here]. It piqued his interest as for the first time it appeared possible to do brain stimulation in the office. “I saw the potential advantages over ECT which included time efficiency, convenience for the patient and lower side effects, including the absence of cognitive impairment,” he says.
In O´Reardon’s view, TMS will remain complementary to ECT but will not replace it. “ECT has the advantages of being more rapidly acting, more efficacious overall, and better if there Dr. John is marked suicidality. TMS, however, will be earlier in the treatment algorithm than ECT with fewer side effects and may in fact work if ECT has failed. We found [Connolly et al, 2012 J Clin Psy, ed.] that there was 40% chance of success with TMS if ECT had already failed,” he says.
New TMS modalities
Theta Burst, a patterned form of rTMS, is another treatment modality which John O´Reardon believes may ultimately have more promise than the standard 10Hz TMS protocol and further mentions sTMS (synchronized TMS) which is currently in trials and offers the potential of EEG-based TMS. According to Dr. O´Reardon, the possibility of at-home treatment may become a new frontier in treatment delivery as it would, obviously, be enormously convenient for the patient.
Combination and augmentation approaches
Another important issue will be the development of combined medication and psychotherapy strategies. There are two basic approaches here, combination and augmentation approaches. With a combination approach, an antidepressant and TMS are started together at the same time in the hope of a more complete result. In the augmentation approach, in the case of non-response or non-remission, TMS is added at 6 weeks to augment or enhance the antidepressant effect. Cognitive therapy can also be used to activate the prefrontal cortex immediately prior to TMS delivery to enhance its efficacy. This is a type of augmentation strategy for TMS but these approaches have yet to be studied, according to Dr. O´Reardon.
TMS ‘dream machine’
When asked to define his ‘TMS dream device’, John O´Reardon describes it this way: “It would be more compact, cheaper, provide an all-in package including theta burst, with a coil curved better to fit the shape of the head, with guidance from research as to how to optimize the TMS effect with medications and psychotherapy, and ability to deliver a treatment protocol in 1/5th of the time
Dr. John O’Reardon received his medical degree from University
College Cork in Ireland in 1984. He is board-certified in primary care
in Ireland and the UK.
He completed his residency in Psychiatry at the University of Pennsylvania.
Post-residency he did Fellowships in Psychopharmacology
and Cognitive Therapy.
His areas of interest clinically are treatment-resistant mood disorders
and neuromodulation therapy (ECT, TMS, DBS, VNS, dTMS,
sTMS and tDCS). Research wise his main interest has been the
development of new neuromodulation treatments.
He has been involved in large scale trials in TMS, VNS, DBS, sTMS
and tDCS. He has over 100 scientific publications, including 29 in
the TMS field.
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Link to FDA clearance
Caution: US Federal law restricts this device to sale by or on the order of a physician. The treatment may not be effective or appropriate for all patients, and additional side effects may occur. Please see the complete instructions for use, including warnings, precautions, and side effects, prior to use. Licensed physicians considering the application of rTMS must consult MagVenture Inc. and the relevant scientific literature to learn more about the treatment and potential risks.