rTMS for the Treatment of Tinnitus: November 10, 2015

 

so tonight we’re fortunate to have two featured speakers from a TA scientific advisory committee dr. Marc minima and dr. JD Carrillo who have joined us from Little Rock Arkansas and st. Louis Missouri to talk about an area of research they have both been working on and that area is repetitive transcranial magnetic stimulation you will hear us all refer to it as our TMS we also have Melissa Dupree an ATA member who will share her story about her journey with Canada and Jody axis and Jennifer borne with us from the HEA staff who will be talking about ata and helping to facilitate the webinar tonight so whether they’re in the video or the behind the scenes we want to thank each of them for donating their time and spending the time and night with us but before we begin I’d like to go over a few housekeeping items as well as direct you to some of the functions you may be asked to use during the course of the webinar on your control panel during the webinar you will be asked to answer a poll to answer the question simply click your answer with your mouse or using your touchscreen if you’re on the telephone of course you will not be able to answer these questions but answer them in your mind if you wish if at any time you lose the audio connection through your speakers please use the dial in information provided in the email you received if you lose both audio and video connections just click the link you use to join the webinar to rejoin at any time if you experience any other technical difficulties related to joining the webinar please contact citrix customer resupport at one eight eight eight six four six zero zero one four again if you’re on the phone and you can’t get in on the webinar call one eight eight eight six four six zero zero one four at the end of the formal program there will be an opportunity for a question period this is oftentimes the most popular partner a big popular part if you would like to submit a question please use the question feature in the control panel due to limited time we will not have an opportunity to answer everyone’s question but please do submit we may be able to use the questions in future webinars or in the Q & A column in our magazine tentative today so please participate I would also like to address you to some of the futures in the control panel you are in control of how you view the webinar you have the ability to make the presentation of full screen or not so just simply look at the little notch at the bottom of the video portion you can place your cursor there and pull it down and you can enlarge the speaker to view them full screen or you can enlarge the full screens by dragging the corners of the entire presentation so that you can enlarge the whole presentation if there are slides showing the video view will automatically reduce the speaker at the top of the slide so that you can see the slides if you please take a moment to familiarize yourself with these features they will come in handy as the program progresses now before we get to dr.

 

Minnow Myers presentation on rTMS I’d like to introduce you to Jennifer Bourne AAA’s program director jennifer has been with a TA since 2006 and just works for the organization in various capacities including as editor of tinnitus today she graduated from Hofstra University in Long Island New York with a degree in communications in 2003 and her professional background includes public relations and public policy she brings a wealth of knowledge about atas history and programs with that I’d like to turn the program over to Jennifer to tell you a little bit more about ata Jennifer Thank You Melanie and thank you all for joining us here this evening before I begin I’d like to take a quick poll of the audience you’ll see the poll appear on your screen in just a moment and the question is how do you say tinnitus can you say tinnitus or do you say tinnitus and while everybody’s walking in their vote I’ll tell you that whichever way you say it you are correct the reason I bring this up is because tonight you will hear it both ways most patients and laypeople like myself will say tinnitus and most clinicians and researchers will refer to it as tinnitus now the reason for this is because the itis implies inflammation and with tinnitus there is no information that we know of however because ata was founded as an organization to serve the patient community you’re mostly referred to in the public as the American tinnitus Association you’ll see it half-half those are the results of the poll so we’re all correct okay anyway that’s APA APA was founded in 1971 by two doctors Jack Cornyn and Charles unit Charles was suffering from tinnitus and Jack’s was one of the few people conducting to know that research at the time like many people with tinnitus Charles was really motivated to find something that could help him get rid of this ringing in his ears when he found out about Jack research he called him up and he asked him if he could help him Jack was just getting started and he unfortunately didn’t have anything tangible to tell him but he told him that he would keep him informed of the progress of his studies and they hung up the phone a week later Charles showed up at Jack’s door Jack didn’t know we could do with him but he figured since he had come all that way from California Oregon that he could at least take him to lunch so a few of his colleagues did just that now if any of you have ever been to the downtown Portland area you will know that there are many water fountain decorative something throughout the city the restaurant that Jack – Charles – just happened to have one of these water fountains just outside the door as they were walking into the restaurant Jack noticed that Charles was no longer with the group he turned around and he saw him standing next to the running water Jack went over to see if he was okay and Charles stood there look of shock and awe on his face he told Jack standing here next to this running water this is the first time that if not heard Mike knighted since it began it was at that moment that Jack had an aha moment a chance encounter between these two individuals and a little know-how on Jackson led to the first clinically-based sound therapy that we all know as masking it also led to the creation of the American tinnitus Association they both knew that there was a great need for all people with tinnitus to get the help that they needed to learn more about their condition and most importantly to continue to conduct research to better understand this condition these core principles education research support and eventually advocacy were part of what a th set out to do from the very beginning and they’ve remained the core of our efforts to this day a little later in the program I’ll tell you a little bit about 88 rich funding of research history but right now I’d like to turn the program back over to Melanie to introduce our first featured yes Melanie back to you Thank You Jennifer for that brief history on a chaise beginnings and for explaining a bit about 80 A’s admission to our audience now I’d like to turn your attention to the main event our speaker is dr.

 

Mark minimize doctor min Amira has been a member of ata scientific advisory committee since 2013 and as a professor of Neurobiology and developmental science at the University of Arkansas for medical services excuse me medical sciences there he has a director of the TMS core research facility in the Center for translational neuroscience where he serves as a mentor to faculty and students whose projects use the core dr. Miniver has been instrumental in developing our TMS interventions for both tentative and addictive disorders in a in addition to a TA scientific advisory committee he served on a variety of other scientific review committees for projects concerning tinnitus including the Department of Defense the DoD and National Institutes of Health the NIH with pleasure I introduce to you dr.

 

Marc minimize to talk about his research on repetitive transcranial magnetic stimulation for tinnitus Thank You Melanie for that introduction it’s great to be here and it’s great to be part of the 80s first webinar as you mentioned tonight’s topic is repetitive transcranial magnetic stimulation and sometimes I’ll say our TMS or TMS for short I’ve had a lot of experience with brain stimulation I started a brain stimulation laboratory in 2004 at the University of Arkansas for Medical Sciences I was working with a colleague named John Dorn Hoffer at the time John’s a neurologist who has had a long-standing interest in tinnitus and he had just returned from a meeting in Austria where he learned about the use of TMS for tinnitus a lot of the original work in this area began in lapped in germany in germany and a lot of the continued work in this area has occurred in european labs so John and I were literally standing in the hospital parking garage when we decided to do our first clinical study and at the time we were funded by several agencies that I want to acknowledge we received our first funding for research from a cobra grant that was awarded to the University of Arkansas for Medical Sciences and Cobra stands for a center of biomedical research excellence we’ve also been funded by the tinnitus Research Consortium and then we’ve been funded by the National Institute of deafness and communication disorders and our laboratory is currently funded by the National Institute of General Medical Sciences finally we received pilot study money from the National Institute of Health clinical science and translation award a CTS a grant to the translational research institute at UAMS so I want to acknowledge these funding agencies because the information I’m giving you tonight would not be possible in large part if it were not for the generosity and support of these agencies ok so what exactly is TMS well TMS is a non-invasive form of brain stimulation and non-invasive means that the simulation is coming from outside of the body during TMS as shown in the slide a coil is had held over the scalp and skull which covers the brain and an electrical charge is discharged through the coil a magnetic field is created beneath a stimulating coil and when this magnetic field enters the medium of the brain it creates an electrical current that has the potential for activating neurons beneath the coil TMS is also delivered in pulses and these pulses are very brief but they can be repeated rather rapidly in most treatments between 1 and 25 times per second and this is the the notion of repetitive transcranial magnetic stimulation in addition the intensity of this magnetic field can be adjusted from very low levels to higher levels so you may be wondering then how do we use TMS for tinnitus well here’s our understanding of how TMS works so beneath the coil each TMS pulse has potential for activating neurons and in most types of chima studies the goal is to repeatedly stimulate an area of the brain for you know anywhere from between fifteen to thirty minutes we stimulate auditory regions of the brain as shown in this slide because we know from previous studies that this type of stimulation has potential for reducing tinnitus perception we also assume that it’s possible by stimulating this region of the brain it’s possible to activate other regions of the brain that share anatomical connections with the stimulated site so TMS is probably affecting more than one brain region even though the stimulation is applied locally in one brain region for example this slide shows our site of stimulation auditory cortex which shares anatomical connections with frontal cortex and it’s chairs anatomical connections with other parts of the brain that mediate emotional reactions to sound the adjacent slide shows mint some of the many anatomical connections between these regions so TMS again is probably affecting more than one brain region and this is an important point because the behavioral affect we see of TMS is also multifaceted for example TMS may not only influence the loudness of tinnitus perception but it may also influence one’s awareness or annoyance or bother of tinnitus as well so it appears that auditory stimulation can have a widespread as specifically used for tinnitus well there really a variety of ways that this is done the best tested approach is applying low frequency TMS over auditory cortex this slide basically shows our set up in the lab where we have a TMS coil that’s centered over auditory cortex during stimulus delivery this approach was originally used because investigators believed that auditory cortex was hyper excited in patients with tinnitus and the logic was that by applying a low frequency of repetitive transcranial magnetic stimulation we could inhibit this excitability and in fact that turned out to be true however the hypothesis may not actually be correct because subsequent studies showed that both high and low frequencies of TMS could have a similar beneficial effect for many patients with tinnitus in addition other studies showed that stimulating the frontal cortex could be beneficial for tinnitus or stimulating frontal cortex in combination with temporal cortex stimulation so the best explanation might be that our TMS influences interconnected brain systems and that it’s possible to stimulate these systems at multiple sites in the brain perhaps the most important question is how does our TMS influence tinnitus perception and again this may occur in several ways one of the problems in answering this question is that not all studies have used the same outcome measures when they’re investigating the effects of TMS on tinnitus for example some studies use questionnaires like the tinnitus functional index of the tinnitus handicap inventory and these questionnaires give you information about how tinnitus affects a person in their in their life other studies have used targeted measures of tinnitus loudness awareness annoyance or bother in order to assess how TMS affects tinnitus perception at any given moment and our studies have focused more on the latter type of of ratings and we’ve learned some interesting things for example we’ve learned that many patients with tinnitus report a decrease of awareness in their tinnitus before any change in their loudness of tinnitus or their annoyance of tinnitus ratings and this is this intriguing finding suggests to us that TMS may actually help patients ignore their tinnitus by becoming more accustomed to it or by not paying so much attention to it so that’s a kind of exciting finding for us when someone benefits from TMS the beneficial effect can last for weeks or even months after stimulation stops for example a recent important study was conducted at the Portland VA and the Oregon Health Sciences University that used the tinnitus functional index to measure change in patients following low frequency TMS stimulation of auditory cortex and this study found that in patients who responded positively to treatment that effect could last for months after the stimulation ended however not all patients respond to TMS in the same way I think the studies show that about 50% of patients may have a positive response to TMS and another 50% may have no response at all this has actually been a major problem for the clinical trials which have been conducted to investigate efficacy for example if you knew in advance that only half of your subjects we’re going to respond to TMS and you and you tested us only a small sample of subjects you might erroneously conclude that TMS doesn’t have any effect on tinnitus when I think it’s more accurate to say that TMS can work quite well in a subset of patients and the more important question is to learn which subset of patients benefit and how they benefit unfortunately it’s not clear at this point how some people respond to TMS and how some people fail that type of treatment but this outcome isn’t really applicable only to TMS and tinnitus most types of medical treatments have treatment responders and non-responders and most medications have treatment responders and non-responders clearly what’s needed at this point is a much larger scale vestigation with multiple test sites and large numbers of patients to really answer the question the efficacy about the efficacy of TMS so some of you are probably wondering if you’re a good candidate for this type of treatment studies have shown that patients with mild to moderate tinnitus or mild to moderate hearing loss may benefit more than patients with severe tinnitus or severe hearing loss however this could also be true of other types of treatments for tinnitus patients with mild to moderate tinnitus might simply respond better to treatment than patients with more severe tinnitus so again more research is really needed to flush out these these findings and to determine and identify you know who’s likely to respond to TMS and and who may not respond to TMS presently in our own studies we simply have to test people to determine who has a positive response and who has a negative response and we think that by separating patients this way that will be the best approach for understanding how TMS actually affects tinnitus perception another big challenge facing this area is to learn how to extend the beneficial effect of TMS as I mentioned in patients who respond to TMS tinnitus tends to return if the stimulation is nearly stopped and it returns to return over time in one pilot study we found that repeating the treatment over the course of many months could help keep tinnitus at a low chronic level in most of our treatment responders and we’re currently conducting another study to see if we can replicate that finding in a larger group of subjects the challenge for understanding how TMS works as a therapy is not only relevant to tinnitus but it’s really relevant to every disorder for which TMS is used as a treatment and they’re actually or there actually is a wide application of TMS in neurologic and psychiatric disorders currently TMS is only FDA approved for the treatment of depression but it’s been used in a wide range of neurologic and psychiatric just first including Parkinson’s disease migraine headache neurologic pain auditory hallucinations in schizophrenia and anxiety disorders just to name some TMS is also used to understand brain connectivity and it’s also used to understand functional specialization of regions of the brain however our understanding of how TMS works from a mechanistic perspective is still very limited and it’s important to investigate this in order to learn how to MS is actually affecting symptom perception and clearly again more research is needed to kind of understand this phenomenon well that really brings me to the end of my talk and I understand that there’s a question and answer period at the end of the program and I’d be happy to answer any questions I can at that time Melanie I’d like to turn it back to you well thank you dr.

 

Menon Meyer for that informative presentation I don’t know about you but I could listen to that over and over again and I’ve had the opportunity to listen to it several times so if you’d like to hear it again we are going to be putting the link in the members section of the APA at 88.2 Largey so check for the website at a later date and go back and listen to it and look at the slides again I know if you’re like me I would learn a lot more so one of the single most important functions of a TA is to directly fund research in fact we just funded a student in this background of grants to look more closely at some of the challenges faced by our TMS for tinnitus to further optimize the therapy so it’s really truly exciting what kind of research is being done and in this particular field we all look forward to the question and answer section and portion of this presentation where dr. Miranda Meyer and dr. picarello will answer some of the questions that you may already have in your mind if you’ve already typed them in we’re going to be looking at that so stay tuned for your opportunity to ask those questions as you may already know all of the research that ata funds is enabled by donations from our members donors and supporters these donations come in almost entirely from individuals by becoming an HEA member you have a stake in the future direction of HEA research by helping ata to directly fund this research to tell you a little bit more about HTA’s rich history of funding research I’d like to turn the program back over to Jennifer Jennifer thank you again Melanie since 1980 when 88 awarded its very first research grant we have awarded over six million dollars in what we refer to as seed grants to researchers throughout the world our grant program consists of funding awarded to both established investigator and to students to help further their their own interests and studies into tinnitus once the grants are received a rigorous peer review process takes place by our esteemed scientific advisory committee which as evidence tonight are comprised of some of the best and the brightest minds working on better understanding tinnitus each grant is evaluated on its merit and ability to push science forward it also must fall into one or more paths on 88 roadmap to assure a document that was created by our scientific advisory committee that outlines four paths of research to basic and to clinical once the grants are scored they’re then ported to our board of directors for funding considerations as Melanie mentioned all of ATS ability to fund research comes directly from individuals our members our donors and supporters and that is something that each and every ATM member can and should be proud of another way that ata has helped push science forward and to increase funding for research is through our advocacy effort over the past decade 88 and successful in increasing federal funding for tinnitus research from around 1.5 million dollars annually in 2005 up to 10 million dollars annually as of 2013 as a result of these efforts the pace of research in Haitian and many new discoveries are now known that we’re not previously known many of you in the audience tonight are ATA members so i just like to say thank you we could not do this important work without your support and contribution i look forward and we all look forward to continuing to work with you over the course of the next few years to work toward a future without tinnitus Melanie I’d like to turn the program back over to youth introduce our next speaker well thank you jennifer for the particulars on AJ’s programs it is true that our members are and have always been the backbone of this organization and that is why ata is presenting these webinars every two months look for the announcement on the January webinar on the website or via email these webinars are a member benefit and you are the ATA so I extend my thanks to each of you now we turn our attention back to our TMS for another enlightening presentation from dr.

 

JP Carrillo dr. picarello a practicing clinical otolaryngologists and Perfector of Otolaryngology medicine biostatistics and occupational therapy at Washington University in st. Louis he has been a member of HEA scientific advisory committee since 2008 he has been an HEA grant recipient as well as conducted a variety of NIH clinical research projects on tinnitus dr. picarello is on the executive and operations committee of the clinical translation science awards program at Washington University which is designed to facilitate discoveries in clinical research and to speed the translation of basic research findings into improved prevention from a clinical trial he has done on our TMS for tendeth doctor pickerel I turned the program over to you great Thank You Melanie it’s good to be here with all of you tonight like my colleague dr. min amar dr. picarello I’m going to suggest you turn the the camera on because we want to see you at the same time we see these slides we can definitely see their lies there you go all right thank you so much we want to make sure we catch everything Thank You Melanie I apologize that technical problem well again it’s good to be here and to share with you some of the research that I’ve been doing like my colleague dr.

 

Minard Meyer I’ve been involved with tinnitus research for a number of years approximately 15 I got involved because I realized that a large number of my patients suffer with this condition and there was just seemed to be so little that I could really offer them and so in addition to some of the new developments and neuroimaging and pharmacology it really seemed like a great time to get started in tinnitus research so I really also want to take this opportunity like dr. min amar to thank the funding agency like the National Institutes of Health and the APA for all their support for research that is done in this area and some we start with them my slides here great so on Terrebonne in discussing neuroimaging research and I’d like to describe some of the exciting research that’s been done in Durham Jenks especially here at Washington University as well as elsewhere magnetic resonance imaging or MRI is based on the concept that the blood contains oxygen and that oxygen gets replenished every time we bleed breathe in so there’s oxygenated blood and then we also be oxygenated blood and that this oxygenated and deoxygenated blood produces a different MRI signal and this difference in the spontaneous MRI signal due to the differences in the blood oxygen while the brain is at rest allows us to study the brain activity so spontaneous folds or blood oxygen level dependent activity looks at the brain at rest and looks for temporal correlations that means correlations over as a marker for areas of the brain that are connected and this animation created below by one of my colleagues illustrates this what we call seed method for identifying regions that are related by the way that they fluctuate simultaneously so here we see the first animation there is areas of the brain sending out a signal related to how much oxygen they’re using we then define a seed region that means a particular area of the brain that we’re interested in shown here in the yellow donut and we ask the question what other areas of the brain are using oxygen at the same level as this seed region and that then becomes the correlated area shown here in purple so this is how we use blood oxygenation at rest to identify areas of the brain that are related so here we show the correlation between the bold signal the blood oxygen level signal and two areas of the brain referred to as the inter pariah ttle sulcus here and the frontal eye field here and shown on the brain and all these red dots represent the actual blood oxygenation level or brain activity between these two areas and that is then transferred into a statistic called a Pearson’s correlation with this black line to show that these two areas intraparietal sulcus in the frontal eye field are strongly correlated and strongly related in their activity in this slide I show another region of the brain the posterior cingulate and that’s shown in this seed area right here this green dot we show the correlation of blood oxygen level in the cingulate with other areas of the brain shown by these different colors and cool colors show relationships in an inverse relationship and cool colors the red yellows are positive correlations so neuroimaging studies conducted at Washington University by my colleagues have identified significant abnormalities in the cortical neural networks responsible for attention cognition and memory in patients with bothersome Tim tinnitus and similar abnormalities have not been observed in non bothered tinnitus patients in this slide I show the brain the cut brains of patients who do not have tinnitus we call them controls and we show the area of the auditory region is right down in here on each of these images and we see that there is strong correlation as shown by this bright yellow in rod oxygen level with the auditory center and there’s actual inverse correlation shown by the cold blue with the auditory Center in blood oxygenation levels up among controls I now show you what the brains look like and blood oxygenation looks like for the tinnitus patients shown and leaves four cuts down here and again we’re looking at blood oxygen level as activity as it relates to the activity in the auditory center and you can see with Kenda’s patients there’s cool colors up in here but what is strikingly different if you look down here this is in the back of the brain or the occipital the visual part of the brain where this inverse correlation is shown by the blue which is not seen up here in the control patients and in addition you see much broader area of positive correlation in the tinnitus patients which is absent in the control patient so we conducted the same type of functional connectivity MRI studies on 18 non bothered tinnitus patients and compared them with the 90s controls and we found we announced the flinch I was done at 89 bothering controls and what we found was disassociations between any of the 58 regions or seeds of the brain that we analyzed that is the non bothered kidneys brains used oxygen and really the same activity level of same relationship as the control brains so since that publication approximately twelve years I’m sorry since since the first publication of the use of our TMS for tens approximately twelve years ago there have been a large number of studies that examine the impact of low when high-frequency our kms and that again this whole idea of dysfunctional networks has been very very important we know about the differential involvement and severity dysfunction across different networks may help explain this well-known diversity in candidate symptoms across different subsets of patients different patients describe different problems and we think that’s related to the various areas of the brain that may be involved so as a result of the findings from the neural imaging and various brain an electrical signal research we believe the focus of today’s research has clearly shifted from focusing on the periphery that is the ear to more the central nervous system and that there’s a now top there on a tension system composed of different subunits including the frontal parietal system the dorsal lateral that are involved in tinnitus the attention network and is defined as I mentioned by this frontal parietal system and it’s viewed as supporting executive control or decision-making the ability of the brain to exert control over which of the many available sensory inputs should be processed the second part is the dorsal lateral prefrontal cortex which is a promising area for treatment in bothersome tinnitus because it seems to be involved in tasked with attention and control and it has extensive interconnections with other areas of the brain including the medial thalamus the amygdala if you will the emotional parts of the brain so involvement of the prefrontal the right prefrontal cortex alone appears to be of particular importance in mediating the affective components of tinnitus what I’d like to do is change my attention if you will to the discussion of the clinical efficacy of our TMS a focus of tonight’s discussion so the first publication of the use of our team that’s our candidates occurred approximately twelve years ago and there have now been a large number of studies examining the impact of low and high frequency our TMS for candidates and although firm studies have shown improvement in tinnitus severity and lasting duration other studies have not found improvement and when an overall average is calculated from the results of individual patients based on the small sample size of these studies authors conclude that our TMS does not work and the key point is emphasized that it is important that more studies of our TMS be completed so the helped us understand why some patients respond and others do not and I’m not going what doctor minimizer said earlier at Washington University I’ve performed two trials of the use of our km/s or Kennedy’s one of them was two weeks in duration and the other four weeks both enrolled 14 patients and Ferren overall no differences in improvement in Canada’s severity between the act of our TMS group and the placebo stimulation group however we did have some positive responders in the trial which I’ll discuss shortly but first I’d like to share with you a video clip demonstrating the actual our TMS on patients so this is a patient in the our TMS trial with the our TMS or device the magnet shown here placed against his scalp and what I’d like you to do is watch the video and listen for the click click click that’s the sound of the magnet as its delivering the rTMS energy okay here we go there comes it is and so that’s a train of the magnetic stimulation it’s like a tap tap tap tap tap on the on the head and underneath is the electrical current and you’re going to hear another train and that gives you an idea of what it’s like and the patient sits there for about 35 minutes for each session as you can see the patient really doesn’t feel much pain or pain or looks bothered in fact several of our patients would actually take that opportunity the 45 minutes to catch up on the map let me share with you two of my patient stories for one subject a correctional officer his initial complaint of his tetanus was that it interfered with his ability to concentrate and in his job at the correctional officer he frequently was required to write down the seven digit inmate number located on their shirt as they move the inmates around the correctional facility before rTMS he had to look at the number several times to correctly write the number but after two weeks of rTMS he described the ability to view the number on the inmates shirt and be able to transcribe the entire seven numbers without having look up again so his improvement was short improvement in short-term memory the second story is a woman who has been unable to sleep through the night for years as a result of her intrusive tinnitus after two weeks of rTMS she was able to sleep through the night her husband unaccustomed to finding her in bed with him in the morning began to shake her violently that first morning for fear that she had died and that explained why she still was in bed with him that morning so our conclusion on from the two studies is and based on a brain is that our TMS really don’t seem to have an effect and some of our patients let me talk about a study that dr.

 

Miller my alluded to it’s a recent study that was published and it’s a problem study about the results of our TMS it demonstrated excuse me enroll at 64 patients who received either active low frequency or placebo our TMS on 10 consecutive workdays 18 of the 32 participants or approximately 50 56 percent in the act of our TMS crew and 7 out of 32 or about 22% in the placebo our TMS group were responders and interestingly improvements in Canada severity experienced by the responders were sustained during the 26 week follow-up period that was quite impressive so what are the current challenges and opportunities related to the use of our TMS for tinnitus I would argue don’t think dr.

 

 

Miller and I feel very strongly about this and talk about it our national meetings but there’s a variety of methodological issues with these studies of our TMS and changes such as small sample size inadequate use of the placebo variability and patient inclusion and exclusion criteria different stimulation sites and parameters and differences in outcome measures all undermined the validity of the results from individual studies and the ability to combine the results across studies the situation today remains as it was in 2006 and one of the key tenets researchers wrote our TMS appears to be a very promising tool for the diagnosis and treatment of tinnitus patients available knowledge is still very limited at the moment for their basic research and clinical studies are needed in order to optimize the parameters of stimulation that is frequency cortical targeted definition and D validate the application of this technique in the management of disabled patients with disabling tinnitus so what needs to be done well we believe larger number of patients need to be enrolled in prospective randomized people control double-blind studies with large sample sizes in addition attempts need to be made to enroll a more homogeneous group of tinnitus patients with regards to their duration of tinnitus and hearing loss and use of uniform and validated tinnitus specific questionnaires and measurement scales as I have my presentation I’d like to acknowledge the grand support from the American tinnitus Association the National Institutes of deafness and other communication disorders the Federal Emergency Management Management Association and the department of defense all of whom have contributed funds to help support my research particularly those with our GMS no way I’d like to turn the program back to you and thank you very much well thank you dr.

 

Picarello for the informative and thought-provoking presentation on the the clinical trials you have conducted and the positive aspect that if we have research we can go further so you what you have learned as a result is extremely important so clearly there is more work to be done on our TMS but it remains a promising area of therapy for tinnitus we’ve learned so much this evening about important research that is helping push science forward towards new treatments for tinnitus but now I’d like us to switch gears a little bit and I want you to hear from an hea member someone who has been through the trials of tinnitus and who has come through on the other side for some people with tinnitus they still haven’t found a treatment or therapy that works for them and that’s why ata continues to fund research toward new treatments and cures but there are some who have and with that I’d like to introduce Melissa Dupree an 88 member volunteer and a dear friend who is here to share her personal tentative took story with all of you Melissa Melanie thank you very much and good evening audience I’ve been very sick with a cold for about a week and this was about five years ago and I kept hearing a buzzing sound in my left ear on and off I thought for sure it would subside but it continued and didn’t stop when this hissing sound started I knew immediately what it was my sister-in-law had a terrible battle with tinnitus and hyperacusis and told me how she suffered over the years so as soon as I realized I had the same battle in front of me I was filled with fear many questions raced through my mind how could this have happened how could this sound have invaded my body and perhaps most importantly how do i rid myself of it after several days of crying and no sleep I decided that no matter what it took I was going to find a solution to this nightmare I first went to an ENT and as many of you know and have probably experienced that was useless he told me there was nothing I could do for my tinnitus and that I would have to learn to live with it after that a point that happened that ENT appointment I was beyond discouraged I turned to the internet for information I read about other tinnitus experiences which empowered me to take charge of my own situation the internet also proved to be useful in finding the doctor who could help me in managing my tinnitus I then found dr.

 

Michael rob an auto neurologist who treated tinnitus was located in Phoenix where I live I made an appointment to see dr. Rob who proved to not only be one of the kindest individuals I’ve ever met but one of the most knowledgeable about tinnitus he made me feel so safe and took the fear out of my tinnitus for me at that time when I really needed it we had a thorough consultation and he suggested that I try sound therapy to treat white tinnitus I were earbuds for eight months and disgust and despite my initial reaction to luring them they did not interfere in my life at all the treatment worked but let me be clear in telling you that I still hear my tinnitus every day however I’m free from anxiousness fear and desperation that it made me feel the sound therapy helped desensitize me to it I have learned to live with my tinnitus but in a strategic and a clinical based way not just by someone telling me learn to live with it today those dark days when I first got tinnitus are all behind me I’m stronger than I’ve ever been and I couldn’t be happier and even though I still have my tinnitus I’m not bothered by it and continue to enjoy doing all the things that I have always loved if there’s one thing that you take away from my story is to never give up and hope that something can and will help you manage your tinnitus my mission statement is someday your pain will become your source of strength face it wave it and you will make it thank you so much Thank You Melissa for that hopeful account of your journey with tinnitus I know that there are many people in attendance tonight who truly appreciate your optimism and for sharing your personal experience many of us have been down that road and understand far too much and now it’s time for the question and answer portion of the evening I know this is probably a time you’ve waited for so we’ll try to get in as many answers as we can I’m going to ask all of the participants to come up on video will only turn our microphones on when you speak and and are answering a question but we’d like to also acknowledge all of the various ones Jennifer and others Jodie asked most she also works at a TA and she’s been working all of the functions behind-the-scenes forests and of course you met Melissa and dr.

 

Minima and dr. picarello so we are going to bring up a few of the speakers and then we’re gonna have a brief question we’re gonna ask each one to answer it as quickly as you can and then if we need more extensive answers we’ll answer these in tentative today or in another format another webinar here’s the first question and we’re just gonna go with what’s been asked by by you the member I have had tinnitus for 10 years I’ve tried film therapy but it did not work for me are there any current clinical trials going on for our TMS that I could participate if not do you have any suggestions about what other exciting or experimental therapies that are out there that I could try dr. picarello could we start with you I’m not aware of any right now open to the general public the one that conducted the study I talked about the positive study maybe but that would be veterans only not open to the general public so at this point no I wouldn’t say there’s any clinical trials of our team that there are some practitioners who may be doing it as a clinical service so other exciting treatments we’ve been doing a lot with stress reduction using mindfulness based stress reduction for our patients with tinnitus as well as we’ve had some really positive experience with computer-based brain training programs a ton of things that you see advertised on the TV to help improve memory perception cognition great thank you dr.

 

Picarello dr. meadow Mayer would you like to respond to that question um I get asked this question all the time in emails and you know we actually have a clinical trial with our TMS that’s kind of completing right now so we’re not really enrolling a lot of subjects in that that clinical trial and that’s unfortunately the news I have to give all these people who email me and what you know once try to get into the study if you’re trying to look for a clinical trial that uses some form of brain stimulation or TMS if you go to the clinical trials.gov website and search under tinnitus you may have some luck finding something in your area almost any device study would be registered in clinical trials.gov and any funded clinical trial for tinnitus should probably be registered in clinical trials gov as well so that might be a resource for people who are looking but I really do get asked this question all the time and you know it’s you know we have we do our studies when when we can be funded on those studies and when we can support the research so that in and of itself is a full-time job and it just you know keep these studies going so trials.gov as a resource okay well thank you that’s what we need our new resources and here’s another question that was asked is our TMS covered by insurance dr.

 

Pickerel well our TMS for depression okay dr. meadow Meyer yes that’s my understanding – I think Jays correct that they’re actually all right you know codes for our TMS treatment for tinnitus that are billable codes but that does not exist for tinnitus and mostly because we don’t have FDA approval for the treatment of tinnitus or for that indication well and that brings us to another question that was asked I mean how long do you think it would take to get FDA approval for attentative um so it would take him he would have to occur in stages and I think that there are phase 2 and phase 3 stages of these research projects that have to be completed so the larger scale research projects would be required multiple sight trials with large numbers of subjects basically to demonstrate efficacy for the technique I think that’s the evidence the FDA with one and those trials would cost in the millions of dollars to fund and it would probably be more than study that would be necessary to provide the evidence that’s required so um it would take years you know to try to complete this task but if you don’t start I mean it will never be completed so it would take years to do and it would take millions of dollars to fund but that’s how FDA approval occurs in lots of other instances so it’s really not unusual that way and J I think you had some thoughts on that as well never get there and that can be one con currently so it’s absolutely doable in four or five years okay thank you well we’re getting close to the end of our scheduled hours so we only have time for one more question and that’s going to throw this over just a minute or two but I’m gonna go ahead and ask this question because it was one that was asked by a number and it was mentioned that a TA has funded a student grant to further optimize this therapy what exactly will the grant that a TA funded aim to do and Jennifer would you answer that quickly sure so the student grants that we funded is hoping to determine the part of the brain that is most responsive to PMS is also looking to determine the appropriate length of time for the treatment and duration and to look for the best placement of the the magnet or the coil which delivers the magnetic pulses and so hopefully we’ll we’ll get some further answers on on those areas of the therapy and optimize it a bit further for treatment well folks our time tonight is just about up I want to thank you all again for attending 88 first webinar and making it a success I truly hope you got as much out of these presentations as I have and it is my hope that you will join us all for the next webinar which will take place on Tuesday January 2 well 2016 same time in same place it’ll be on a Tuesday night this webinar will be featuring dr.

 

Norman razz she’s an audiologist in Childre who will discuss current clinical practices on Canada and hyperacusis management strategies how she sees them work for patients and dr. grant search field PhD from the University of Auckland in New Zealand who is also one of 88 scientific advisory committee members who will talk about some new sound therapies that are being researched currently and the research supporting why sound therapy works so registration will be soon and it will be available on a chaise website at a Gao RG and I also want to thank our presenters again dr. Markman Amaya and dr. Jeffrey Carrillo for volunteering their time and expertise on our TMS and for sharing with us some of the important new frontiers they’ve explored and what they’ve discovered with their research as well as noting what future work needs to be done yet for our TMS it’s a viable therapy for tinnitus community we are truly fortunate also to have Melissa Dupree come share with us her journey so we want to thank her for that and for each one of you attending Jodi and Jennifer it’s been a great night thank you again for joining us and we hope we will see you in 2016 at our next AGA webinar good night

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