Breast Cancer Symbols

[...is now being recorded] [wendy nilsen] good afternoon, this is wendynilsen at the, of the office of behavioral and social sciences research here at the nationalinstitute of health. hope you're having a lovely afternoon. today i am very, very excitedto introduce a wonderful researcher, a wonderful colleague and an ex-federal servant like us.ron poropatich is here, and he's the executive director for the center for military medicineresearch, health sciences at the university of pittsburgh. prior to this, he was deputydirector of the telemedicine advanced technology research center in the united states armyand he was actually a colleague and friend to many of us here in d.c. doing really wonderfulwork. and i think, we're very excited to have

you here today and i'm going to let you takeit from there ron. [dr. poropatich] wonderful, well wendy thankyou very much for this opportunity. it's a genuine pleasure to be here among friendsand to be back at nih and to spend a few minutes talking about mobile health and the use ofmobile health in rehabilitation. and i use that word 'rehabilitation' broadly to includeany patient recovering in the home from a variety of illnesses. and so what i wantedto do in terms of starting of is, again, credit my co-investigators at the university of pittsburghon the second slide. do i advance, will i advance or you advance? so, okay. so againthe acknowledgements to my colleagues dr. bambang parmanto, walt schneider, anne germain,anthony kontos, john chmura, dan pultz, norah

pearson, and david okonkwo. we're involvedright now in a dod funded research project on traumatic brain injury and we've got alegacy of doing mobile health at the university of pittsburgh where i've been for the last2 years. and i was doing mobile health in the u.s. army prior to this assignment tothe university of pittsburgh, but because of the preexisting work at university of pittsburgh,we've leveraged a lot of the folks there to be involved now in this traumatic brain injuryproject. so i'm going to talk about over the course of the day. can i have the mouse todrive my own slides? what i'd like to do is just over the course of the brief time i havewith you all, is give you just a general overview on mobile health, talk about the universityof pittsburgh tbi project and how that evolved

from other mhealth tele rehab applications,and then just spend a few minutes summarizing the efforts. it's important to realize thata lot of the causes of traumatic brain injury stem from trauma and trauma is the number1 cause of death for americans 1-44 years of age, it's the number 3 cause of death overallin the country, and trauma accounts for 41 million er visits, a third of all life yearslost, and the economic burden is over 400 billion annually and 180,000 people lose theirlives to trauma each year. the, again, other points i wanted to bringout in addition to trauma, it's a common cause of traumatic brain injury. and traumatic braininjury is one of the key aspects of the tele rehab mobile health project i wanted to talkto you about. there are over 1.7 million a

year sustain a traumatic brain injury withover 50,000 dying in the u.s. causes primarily are falls, motor vehicle accidents, and i'mjoined here at the nih by dr. florence haseltine as well. it's wonderful to have florence asa colleague and friend talking about falls and tbi just before we started this lecture,in fact. but tbi is ubiquitous, every 20 seconds someone in the united states suffers a traumaticbrain injury and males are 1.5 times as likely as females and the 2 age groups are the veryyoung and those 15 to 19 and costs are very high and the cdc estimates that at least 5.3million americans currently have a long-term or lifelong need for help to perform activitiesof daily living in their normal environments. and again what i want to talk to you aboutis how do we personalize and provide self-management

for those with tbi, trauma, ptsd in theirhomes and in addition to tbi and ptsd, we're over 5 million people in the united statesare effected in the united states with post-traumatic stress. and coming from 30 years in the armyas a pulmonary critical care doc and having seen a lot of tbi and ptsd in my militarycareer, it's important to know that a lot of the projects that we've developed in thedod and what we're doing at the university of pittsburgh funded by the dod has greatrelevance to the civilian community as well. but in addition to those key injuries, spinalcord injury is also a very common problem with over 50,000 deaths a year in the unitedstates to spinal cord injury. cerebrovascular accidents especially stroke and rehabbingin the home another key patient population.

and then orthopedic and neurological disorderssuch as amputation in the military population. we've got close to 2,000 amputees. and againhow do we use mobile health in the home with somebody that has an amputated limb that probablyhas tbi and ptsd? and how do we individualize and personalize the management in the homefor individuals like that? so with that background just a very briefword on mobile health since i assume this is a very sophisticated audience. again it'sthe use of mobile devices, both cell phones and tablets, to improve health outcomes, healthcare services, and health research. this was the nih consensus group definition i haveto use since i'm here at nih, i figured i better use that definition. and again whymobile health? people don't adopt mobile devices,

they really marry them and i bet there's nota person listening out there that does not have at least one mobile device. i've gotat least two tablets and two phones and i see wendy's holding two phones and one tabletand dr. haseltine's got her google glass. and so we've got all sorts of mobile devicesand the good outcome is that we never feel alone that's our companion, it's a very usefultool. the bad outcome is we can never escape. we've got this constant nag and we've becomeaddicted. we've got it next to our bed. we use it as an alarm clock and then people textus or call us and we get fragmented sleep. but there is an incredible opportunity, though,to personalize that mobile device. and how do we personalize it in the context of rehabilitationcare? that's what i want to talk to you about.

this is a slide that the surgeon general ofthe army, general patty horoho, put together a couple years back and it talks about a circlewhere, that circle comprises all the minutes of the year. so there's over 555,600 minutesin a year and a typical patient has roughly 4 patient encounters during a year, each onelasting roughly 30 minutes. so there you take 120 minutes out of that total 500,000 plusand we really are providing patients with a very limited opportunity. and the wholepoint is how can a mobile device connect a patient more fully to the health care teamand to family members who are all working towards them getting better or staying healthy.so filling in the white space is what we talk about. and again the other key technologyand capabilities that we talk about, it has

to integrate with the electronic health record,i talked about social networking, the whole issue of smart bandages and sensors continuesto evolve. secure messaging is the best mechanism which allows us to exchange information ina hipaa compliant way. with good outcome-based metrics, which is what we need and which iplea for in this talk, in order to come up with better understanding of the science ofthe use of mobile devices in healthcare. the mobile learning, or as we say in the militaryhip pocket training wehere i take up a phone and i look at relevant 3, 4, 5, 10 minutelectures, podcasts we're all used to, medical imaging on the phone now i can make diagnosesat a distance. different web services, telemedicine etcetera. there's a lot of things we can doon a phone and so the approach that we take

and that others take as well, but it's animportant approach, it's all about self-management. how do i empower the patient to take chargeof their situation? and scale it to various geographic locations and a variety of healthconditions, many of which, you know, patients for example with diabetes or heart failure,often times those two illnesses go hand in hand. however, there are other things suchas amputated limbs and polytrauma and tbi and pts and a wheelchair and the difficultiesof adjusting to a prosthesis. putting a patient in a wheelchair. so there's a lot of unusualsituations that we're trying to get our arms around in a cohesive plan that i want to sharewith you. the whole point is that we want to intervene, we want to monitor, and we wantto stay engaged with the patient. and that

engagement is hopefully going to increasethe patient's self-care skills and improve outcomes by changing their behavior. makingthem realize that we care about that. it's important that we talk about mobile health.we talk about the ecological momentary assessment and the ecological momentary intervention.by that i mean, when i am going to see a doctor and they say come back in 6 months, and overthat 6-month period until i come back to the doctor maybe i've had insomnia, maybe i'vehad nightmares, maybe i've had new pain. how do i get my problems that are bothering meright now to my health care team? and that ecological momentary assessment is the wholepoint of now that you're having the problem, your health care team is aware of it today,we're going to do something about it as opposed

to 6 months later when you come back to seeme where that problem may or may not exist. it may be worse. so the whole goal of mhealthis personalization and interactive health services anywhere any time using a mobileplatform. i've used this picture a lot in mobile health talks. i just love it from thenew yorker or babies in a bassinet and "oh my god i just got born" but it's just as funnyfor me now as it is 4 years ago when it appeared in the new yorker. and again what we are doingnow on this dod funded project for traumatic brain injury is targeted evaluation actionand monitoring team for traumatic brain injury (tbi). so, it's funded by the dod, monitoredmultiple interventional research trial designed to parse out the heterogeneity of tbi andidentify evidence-based treatment protocols

that are individualized to the patient. eachparticipant departs pittsburgh with a customized toolkit on an ipad that they take with them,on their phone that will allow us to stay engaged with them. and i'm going to sharewith you what we're developing. when we look at tbi and team tbi it's a 6-month,they come and get evaluated, 6 months later they come back. during that 6 months whenthey're away, we customize their problems for tbi into a variety of trajectories sowhen they come to pitt, we identify whether their traumatic brain injury has a vestibularcomponent, an ocular component, some of them have difficulties with accommodation, cognitiveproblems where they have memory issues, short-term/long-term memory, processing speed, effective disorders,anxiety disorders, sleep problems as well

as cervical/spine problems. and so what we'vedone is identified treatment pathways that go along those trajectories and those pathwaysare programmed training that we ask them to do. we titrate the programs and the trainingfor specific intervention and encourage and ask them to continue to use it and then wemonitor it real-time to make sure that those responses are being stored in the databaseand then seeing whether we're actually making a difference in their life. so this littleschematic sort of shows you those trajectories, again sleep, anxiety, mood, vestibular, ocular,cognitive, migraine, general well-being if you will. in the middle of the imaging pieceand this traumatic brain injury project is really focused on imaging it while lookingat magnetic resonance spectral imaging, high

definition fiber tracking which is a spinoffof diffusion tensor imaging. so the imaging piece is a key that goes onto the mobile platformso they can actually see where there's fiber breaks in their traumatic brain injured brains.they can show family and friends and other providers, along with a variety of tools,these trajectory tools if you will that are on the outside of the imaging. part of thediagram that i'm going to share in a little more detail with you on. so this is our littlelogo for team tbi. it includes the department of neurological surgery, the department oforthopedic surgery, the department of psychiatry at pitt, as well as the department of psychology,radiology, as well as the center for military medicine research where i work. and so itleaves the question "so what do you have in

the box, ron?" so what we have in the boxis a variety of items. hardware, software, fitbit, a variety of things that they're allgoing to get. and again the software on this ipad mini is, some of it is under developmentand some of it has already been developed and i'm going to share some time with youon that. and again the approach is, the patient comes into our clinic for a week. they stayin pittsburgh, they get consented, fall under irb, they undergo a variety of imaging, neuropsychtesting, sleep study, cognitive testing in the concussion clinic, blood work, etcetera.and after all that testing is done, we have a multidisciplinary panel gather in a largeroom and we come up with a specific, tailored treatment regimen for the patient. and thatis all done during the adjudication phase

of the evaluation and then we individualizeand adapt a self-management tool on the mobile device. and that's what we give them. thoseinterventions are including sleep, vestibular exercises, cognitive rehab, wellness tips.and the important point is that these are self-assessments performed according to anindividualized schedule that we know that the patient has other things going on in theirlives and for us to say "do this at 10 o'clock every day" may not work well. maybe they wantit first thing in the morning, late at night, maybe they want it during their lunch break.and so all this is sort of sorted out and the key players are the patient, the patient'sfamily, the health care team, as well as a coach. and so we've got ex-military healthcare providers that are coaching these individuals

along with a health care team making surethat they're doing what we want them to do and helping to encourage them to be activeparticipants. so the compliance includes an application, a log in. we check their clinicalcourse and hopefully they're getting better. and then they get subjective feedback in termsof is it really helping? over a 6 month period then they come back, we look at all of thisas they're an outpatient, we're hoping to make early adjustments to their clinical situationand hopefully seeing improvements. so the participant goals for this toolkit is to improvethe daily lives of participants via this genuine concern, this clinical intervention and followon the cifo. clinical intervention and it's all about follow on, it's all about peoplereaching out. even though technology is wonderful,

it still requires a great deal of human interactionespecially in a research study. and we want to demonstrate, again, genuineconcern, trust, and retention in the program so we've developed training tools, scaffoldingtools, communication tools to increase effective participation in the rehab program and tostrengthen intervention effect. so what we've developed and what's in the toolkit softwarewise, we've got common trajectories and priorities that are already in place. we've developeda sleep tool, memory looking at both working and prospective memory, an anxiety and a depressionseries of tools that'll show you attention, cognition, and wellness tips. so that's alreadybuilt and being used and in addition we've got these additional clinical interventionfollow on areas such as vestibular and ocular

exercises. we have those exercises identified,we're putting it onto an electronic medium right now. and so it's got a little introductionabout this is the exercise you're about to do. here's a video on how you do the exerciseand then here's a pdf if you want a schematic of what it looks like. we've got pain migrainehow-to videos such as good sleep hygiene, rehab tools, home exercises. cognitive behav9ioraltherapy or cognitive rehab therapy is a really difficult area. we looked at good days ahead,there's luminosity, there's a lot of things out there and we found really a paucity ofdata showing really strong objective results in these kinds of mobile health tools thati'll talk about. appointment reminders, anxiety/depression such as breathing training are also underdevelopment. so the support staffing on this

project is really important to emphasize.this is a human supportive system with multiple interactions linked to monitor encouragedtrack involving family members, weekly facetime with key individuals. we kick off the formalstudy, we've done a pilot with 7 individuals already. the formal study kicks off on 25august, a little over 6 weeks from now. it includes a coach for outreach, clinical coordinatorssupported by the research team with domain expertise in cognitive sleep, post-traumaticstress, vestibular, etcetera as you see on this slide. so the human element is key. ifyou look at the sleep and tbi piece called irest again it's got the sleep diary, it'sgot the sleep tactics, sleep thinking and bed tactics, sleep briefing, a variety ofcoach techniques that's part of a project

that we're doing right now in the militarypopulation as well with traumatic brain injury. so we're porting this software into this otherprogram. so irest which is the sleep app includes this ecological momentary assessment and intervention.so you discuss the problems with the patient while they're being experienced such as insomnia,not days or weeks later. it's called the mobile brief behavioral therapy intervention. sobased on their sleep diary, we calculate their average sleep and average wake up time andauto prescribe a sleep prescription, when to go to bed, how long to stay asleep, whento wake up and based on their sleep problems we also provide related education materials.the sleep tactics i was referring you to such as restful sleep, stop thinking in bed, getrid of nightmares. they may come in not having

nightmares, but over the course of 6 monthsdevelop nightmares, which is why this interaction with the health care team is critical becausethen we can push on to their local platform these kinds of tactics relevant to a new andemerging problem. and then just general education about sleep. so again it all comes with allof these kinds of mobile health tool with a dashboard and the printout. this is a realchallenge to read, i understand, but the same things for sleep in terms of a dashboard,we've established for affect and mood, and this is being used in a variety of studiesprimarily in the pediatric population and we're porting that over to the adult populationas well with very simple, you know, likert-type scales of 0 to 3, you know, picking how yourmood is and then monitoring that with a dashboard

over time so that the health care team, thepatient, the family can all see that. in terms of anxiety treatment, what were youdoing when the phone beeped? different things to key the patient. and we've used this, again,primarily in the pediatric population for child anxiety and this is a published articleby dr. parmanto, who's part of our team, earlier this year in the telemed journal. in addition,ocular/vestibular is a big problem for tbi and again these are just examples of one ofthe 100 exercises we use for ocular/vestibular. so again we provide a pdf on how to do thetraining, videos of the exercises, and then we're going to have in 2015 mobile trainingapplications using mobile gyros and cameras as well to expand that capability. this isthe key architecture for our platform. everything's

going to be on one platform. so if you lookat the communications of the imhere portal, it's got the directory services, the messagingservices, and the database. that's all on the server. and on the patient's mobile platform,they'll have skin care, self-catheterization, mymeds, it can work on an android, an iphone,or a windows and to provide guaranteed deliveries, hipaa compliance with the various encryptionsthat you see there, and allow complex payloads such as video/audio treatment regimens etcetera.and the other thing that's important is the social networking to enhance compliance. ifyou bring in that patient's family and friends, you can see where you see in this picturea smartphone that has a pedometer app on it and the patient, the user in the little greenshirt. and then off to the right is the community

of interest, the social networking that includespeers, and then peer support and peer comparison groups. and so how does that phone interactwith the patient in terms of self-management? that's number one. goal setting is an internalissue that drives the patient, hopefully changing behavior and motivating them. self-monitoringtheir performance. self-comparison, how they did this week versus last week. and then youget beyond the patient and the device and you get into their community of interest thatthey identified for peer support, peer companion, comparison, social support, and then socialcomparison for competition is an important aspect. and part of this social support we'vedeveloped persona, which tracks their activity and shares with friends and family to showthat they are getting better hopefully with

getting more steps in during the day comparingmaybe with their siblings or their loved ones. feedback comparison and social support againjust to let them know how they're doing over time is the intent here, it's all built intothis. and again when you look at all these applications out there razzed and built thatmaybe we can take something that's already available. there's over a million apps nowout there and so here you see the picture of one million apps this was earlier thisyear. giving someone an app that wastes rehabilitation time or is unused is to be avoided and monitored.we don't want to just throw random apps to our patients. they have to make sense to usand the patients. so giving them a low cost app without supportable expectation of benefitor monitoring is unacceptable such as overprescribing

ineffective medications to patients, avoidingcognitive training, using underutilized interventions. there's a lot of things out there that wedon't want to do. so what we're looking at under cognitive rehabilitation therapy, we'velooked at all of the commercial products, we've pulled together a panel of experts,both industry, academia, and government. and we've looked at all the different productsout there. we've also compared out list and our experience with what the u.s. army did.they pulled together a team of experts earlier this year. prepared a 78-page paper on allof these cognitive rehab tools. i think the bottom line is there's nothing out there thatwe found either in our internal panel with experts as well as the u.s. army that's reallybuilt on good, solid data that's prospective,

randomized study showing meaningful sustainableeffect. so we feel there's limited data that has undergonerigorous study, but the key focus areas for the cognitive rehab piece, we're looking atshort and long-term memory, we're looking at processing speed, and we're looking atexecutive and working memories. for example, can we improve their gre scores? can we improvetheir ability to do email with family and friends? the other thing that's importantin post-traumatic stress is the whole concept of mindfulness and being able to find thatinner-peace within yourself to sort through difficult times and to handle difficult times.and so there are some commercial products out there that i didn't want to bundle intothese other cognitive areas, but some of the

mindful products we found very helpful suchas posit science and we're looking very closely at that. so again we want this software thatwe're either building or looking for commercially to be agile, to be opportunistic, to be integrativefor common launching and monitoring and to be evolutionary. we want to try small things,try things in small groups and then pull away the poor performers. and so this is a constantiterative process. so the challenges and limitations, we don't have the evidence-based data to identifywhat works today and deliver successful intervention that will work on the typical person for today.so what research metrics are we using? you know for example, what mobile training programwill enable a medically discharged traumatic brain injury case over 6 month training programto regain attention and working memory to

succeed in reading for a job, such as doingemails at work. education, can they successfully complete junior college? can they get goodscores to get into junior college? and then enjoyment in general in terms of pleasurablereading. are these reasonable metrics? and so how do we leverage the mobile health developmentthat has been going on at our university and other places in traumatic brain injuries,sleep, post-traumatic stress. there's a lot of data out there on chronic disease, heartfailure, diabetes, etcetera. and put it into this broader context now of rehabilitationand rehabilitation care. so i'm going to show you just some of the work that we've doneearlier in spinal cord injury. and what we want to do in the amputee population becausemany of these patients with tbi, ptsd have

spinal cord or traumatic amputation. so whenyou look at where we've been, we've got again in tbi, memory, attention, and cognition asa key part of some of the key tools we're building. in post-traumatic stress you deala lot with sleep, anxiety, and depression. this is where mindfulness as a tool comesinto play. in prosthetics, we want to do at home gait monitoring, the machine-body interface,skin breakdown. a lot of guys don't want to wear the prosthesis because they're just notcomfortable on it. they fall, so they're back in a wheelchair. we want to avoid that. andso we don't want skin breakdown so if i put pressure sensor, pressure temperature sensorsin their prosthetic liner, can i prevent skin breakdown by understanding these problemsearlier and doing something about it? and

then looking at wheelchair use in terms ofmachine-body interface and skin breakdown. so here's an example of a genium bionic prostheticmade by ottobock. you can see that these prosthetics are extremely advanced with gyroscopes, twoaxis accelerometers, battery, hydraulics, bluetooth, knee moment sensors, ankle momentsensors and axial load. i mean there's a lot of technology that goes into these. this isnot a wooden peg, this is a very sophisticated piece of technology. and so how can i continueto monitor this patient at home? and so the sensor configuration was integrated with mobiledevices and energy harvesting. so the energy harvesting piece coming from the heel strikeon the ground powering the sensor in the prosthetic itself. and so these are the things that we'relooking at and built into a research proposal

so we've developed all this into a prospectiverandomized study for an amputee, lower extremity only, population that has been submitted tothe dod and we're waiting to hear if it's going to be funded. but it leverages on themobile half that i've already talked to you about with tbi that i will be talking abouton spinal cord industry. the data will flow to the phone that goes to a server then theprovider-enabled home monitoring. it is so important to stress that you have to be ableto have someone tracking this on a regular basis. so the challenge for example how doyou monitor 3 prosthetics in an integrated way? so here's an individual with two lowerextremity and an upper extremity prosthesis and again, these can get really challengingnow when you've got 3 different prosthetics

generating data trying to provide optimalperformance in the home. there's also a lot of applications that we'vedeveloped that, again dr. pamanto is a wonderful investigator in this space. and who i wouldencourage wendy to bring in to spend some time on a future webinar supporting self-careand management of chronic and complex spinal cord injury. and so bambang is just a greatguy and the problem with spinal cord injuries is you've got secondary complications suchas urinary tract infections and wounds and these secondary complications lead to expensivehospitalization. so how do we promote a wellness program where a wellness coordinator, ot/pt/nurse/communityhealth worker, helps the patients do the self-care? and when we've studied this, it works well.the program pays for itself by avoiding these

secondary complications. so another articlepublished by dr. pamanto in the wheelchair population where you see again they have facebookserver, portal server, there's all sorts of sensors on the wheelchair and on the patient'sarm in a wearable unit. and again they've been monitoring this and they published theresults. it's in press right now for a publication that will be coming out later this year. andagain it's two-way dynamic real-time communication. it deals with the patient and the family andthe health care team. has medication apps, it's got skin care apps already developedand this is where we're repurposing a lot of things that we've done in other populationsand sort of bundling under rehab. just like we bundle a lot of stuff under chronic carein mobile health. and so that's why i used

the term 'rehab' i'm using it loosely. thesecure messaging between the patient and the clinician as we've been doing in other appsis going to be important and again that kind of tele touch, that outreach to the patientwill hopefully motivate them. so those mhealth components and tele rehab in general, that'scritical here is the secure bi-directional communication, clinician supported self-care.that is really important for both medications and skin and wound care in the case of theamputated limb or in the case of the patient in a wheelchair. the secure messaging betweenpatients and clinicians, sensor-based activity monitoring, and the continuation of successfulremote monitoring features to look at both sleep, ptsd, cognitive behavioral therapyas well as personalized intervention. for

personalized intervention there's deep breathing,there's certain things that we can repurpose where maybe, you know, in terms of relaxationand mindfulness, you want to get patients breathing right, doing diaphragmatic breathingas opposed to shallow breathing, which most adults tend to do. we don't focus on our diaphragmaticbreathing anymore, which is what children do primarily, but that's just an example.this cognitive behavioral therapy game that we've developed called thought buster. badthoughts pop up and you've got to get rid of them. and it's you know you're playingaround with your phone just blowing up bad thoughts and just keeping the good thoughts.and again, just games that might help some people and may not help others, but we needto personalize those kinds of apps because

not everyone's going to want to play thoughtbuster, but we need to identify those that might. so results from tele-rehab implementation.so what we've discovered is that patients have been using, actively and consistently,these apps for our spinal cord injured patients. especially when that app supports their dailyself-care tasks and that's important. clinician-direcdted self-care support works. we've seen clinicaloutcomes that, again in press are already published. patient self-management skillsare improved when they have these tools. and then it's been scalable, we've been capableof supporting large geographic coverage areas in the pittsburgh region and we hope to expandit to other areas as well. so in summary as

i bring this talk to an end, i just want tofinish by saying personalized self-management tools favor results that lead to behaviorchange. emerging technologies such as sensors, energy harvesting will enable greater developmentof these apps. continued research in mhealth is needed with well-defined outcome basedmetrics. we hope to contribute to that literature. and challenges in mhealth expansion continue.there's fda guidelines that come out, there's a lot of different things, but i mean newyork times yesterday had a wonderful article on telemedicine and the compact and how weget across state lines and i tell you, i think this has been the most encouraging i've seenin terms of telemedicine whereby we're now starting to see congressional movement toget telemedicine more ubiquitous in our lives.

so i'm going to stop there, i've left enoughtime for questions and comments and again i really appreciate this opportunity to sharesome of the things we're doing and would be happy to take any comments or questions. [wendy nilsen] alright, thank you so much.i'm going to, all of our users please look at the question/answer screen and write yourquestions in there. i'm going to, but i'm going to take my prerogative here and aska question. on your, i can't remember if you said you'd started with the sensors in theprosthetics? [dr. poropatich] we have not started. we have,some of these sensors are already developed in the liner, so we have patients that haveused it. what we have not done is used it

in a prospective randomized study and so thatis, we've used them for just individual cases. so what we're trying to do is leverage someof the commercially available liners for prosthetics, wendy that can then be bundled into a largerprospective study. this is, again, dod sponsored research in orthotics and prosthetics. [wendy nilsen] i just think it's interestingbecause, you know, i think sometimes people are looked at funny when they're not usingtheir prosthetics, but there's lots of reasons why they aren't using them and the sensorsgive an objective way to help people really communicate some of the difficulties they'rehaving that might be very hard to verbalize. [dr. poropatich] and it may be also anotherway to come up with a better liner. so as

we start studying it more, especially withpressure and temperature sensors, we hope to be able to come up with better materialsthat will allow better air movement, lighter weight, better fit. there's a lot of thingsthat go into the decision of those liners and so we see this population as still beingrelevant in the civilian sector, but as you can see from my military experience it clearlytouches the dod population as well which is why i think it's a great fit in terms of dodfunding in an area that we feel very comfortable dealing with the same patient population thatboth groups see. [wendy nilsen] okay, we have a question fromone of our, from one of our online folks who says "would you talk a little bit about interactingwith the patient at the time events happens?

like insomnia, is someone on call to do that?" [dr. poropatich] yeah that's a great question.unfortunately no one is on call that night when that event is occurring. it's going tobe the next day in the morning. so at this point in time we've got dedicated people totake these kinds of calls from the patient. unfortunately it's going to be a monday throughfriday, normal business hours that we're going to be interacting with the patients. so asyou know from doing research between buying people to do this kind of thing and then payingthe indirects in the fringe, the budget gets really big and we've already purchased 5 individualsfor the study for this kind of outreach for the tbi patient study. so i think just becauseof the economics, we're limited in how often

and how quickly we can respond to the patients,patients' needs. [wendy nilsen] okay, and our next question.i think that's going to be interesting and i also think it might be interesting to seehow much personal touch they do need at those times. maybe reporting it will get them whatthey need. and show that we, when and when we don't need personal touch. [dr. poropatich] yeah, and i think what we'retrying to avoid is 3 nights in a row of nightmares with no one intervening. we're trying to avoid3 nights in a row of insomnia. i mean if you get one bad night, you can usually take itespecially if you know someone's going to intervene and give me some guidelines thenext day or over the weekend. and i think

a lot of people realize that it can't be 24/7,we're not there yet. but i think, hopefully it will help improve recovery by knowing thatthere's someone on the other end with genuine concern who they trust. [wendy nilsen] and is there any smart systemsthere that are providing information when there's no one on call? [dr. poropatich] no, we don't have any artificialintelligence that takes these sensors and then comes back with a way to study that individual.we're familiar with that process of taking data from the patient and then over time beginningto know that patient's needs where you can then come up with a computer-aided recoveryplan for that moment, let's say. we would

like to do that, but we have not yet reachedthe point where we can take all those data elements, put it into a software program thatcan come up with better, predictable and computer automated responses. we're not there yet.we're thinking it. we're thinking there, but right now we're just trying to identify thedata elements. [wendy nilsen] right, alright can you describea bit more in detail what the main specific neuro cognitive rehabilitation tools looklike? aare they genes? what's the dose? how frequently are they administered? [dr. poropatich] yeah, again there's a lotof stuff out there already. good days ahead, luminosity, and a lot of them are. the m-backis one example where you go back so many spaces,

you'll see a screenshot of 3 different imagesin a 6-panel screen. and you'll have to identify on the next screenshot, whether those same3 images that they're showing you in the next screenshot were the same on the last screenshot.and then were they in the same location on that 6-panel or 9-panel screen as they were?and so there's the end-back, there's the other thing we're looking at is reading comprehensionwhere they'll be given small reading sentences, you know, 2, 3, 4, 1 or 2 paragraphs. it'sa short reading test if you will. and then questions afterwards to help them hopefullyimprove their reading comprehension. we know that there's data out there that shows thatwhen you have that kind of intense involvement in, for example, you have to re-certify inclinical investigation. there's a whole series

of legal regulatory lectures you have to take.i mean after you immerse yourself in 8 hours of intensive training with online exams ikind of feel better afterwards. or i feel like gosh i can think better because i'vebeen training my mind the last couple days to work this way. we know there's data thatsupports that and we're trying to bring in good science into the cognitive behavioraltherapy. so the end-back was one example, the reading comprehension is one example.we're trying to not make everything in house, we're trying to find validated tools thatare already out there and it's been difficult. but i think posit science is one that we havegood interest in because they've got some interesting tools. what's more important iswe can port it into our platform. we own the

data elements and it's not like i've got togive someone 2 usernames and passwords, one for our platform and one for a commerciallyavailable product that we're licensing. they're freely interested in sharing that with us,which is really important for us. we don't want to play unless we can leave it on onesingle platform that's fully integrated. so i don't know if that helped to answer thequestion, but it gives a couple examples at least. [wendy nilsen] we have a question it says"can you tell" why do you keep changing it? i can't see what "can you tell" every timei try to read the question, it disappears. "can you tell, can you tell the problem they'rehaving from what they put on the device, or

do they have to call you?" [dr. poropatich] well, we want to be ableto look, so we're going to look at that dashboard. we're looking at the data, so if we see somethingthat's not going well, for example the patient may not call us, but we're seeing that they'renot getting any better in some of their vestibular/ocular testing. we call them. that's why this isreally human heavy if you will, in terms of cost and involvement. so we're not waitingfor them to call us. if they call us, we will certainly intervene, but we plan to call themif we're not seeing significant improvements in whatever aspect of traumatic brain injurylet's say, that patient may have. whether it's ocular, vestibular, cognitive, cervical,anxiety, etcetera.

[wendy nilsen] and i think the related questioni'm going to give you "how do you determine when to have the clinician interact with yourperson versus, i know you have some staff that's doing a lot of the interaction, sohow do you determine who intervenes and when?" [dr. poropatich] yeah, you know when theycome to pittsburgh for their initial one-week evaluation, they get to meet all these people.and so when they leave and go back home, wherever it is, and again most of our patients aregoing to be military. these are all marines and soldiers, so it's army and marines whoare either on active duty or have just recently retired from active duty. and they're comingfrom all over the country. we, they'll meet the coaches, they'll meet the health careteam. not all of the coaches are physicaians

for example, but i would argue that you don'twant necessarily a physician as the only kind of person talking. there's important therapiststhat have important insights and skills that we want them, our sleep therapists are reallyquite good and we want them engaging with the patient. not our neurosurgeon. i meanour neurosurgeon is wonderful, dr. okonkwo, he's the p.i. on the project, but he's notthe guy i want talking to a marine that's having sleep problems. we want the sleep therapistto be doing that or the neuro psych therapist dealing with the cognitive issues. or theocular therapist dealing with the ocular issues. and if we see that they're not doing theseexercises, we have our counters. so when they leave pittsburgh, we tell them look, you'vegot to do this schedule, these exercises and

we're mindful of we don't want to overloadthem in any given day, so we'll stagger them over time. if weekly they're not even loggingon to do those exercises, then we will call them and say "hey, what's going on? we justdon't seem to see any interaction of you doing the things we asked you to do. is there aproblem? how can we help?" so there's that kind of active outreach from people that arehealth care individuals and those that are ex-military that understand the military speak.close in age to the patients. [wendy nilsen] alright, so then, and so oneof our questions is "what patient-reported outcomes, measures will you be using in yourstudy?" [dr. poropatich] yeah, there's, well againfor vestibular/ocular some of the testing

you can do on an ipad. for example there'sa visual field testing that's now available on an ipad that we've become familiar withthat we can actually see if there's improvement in that. are they actually using the exercisesand is the visual field getting better? that's one in that particular regard. is there lessanxiety? so you can give them a likert scale on anxiety or mood as we track anxiety andmood. and are they finding that it's getting better? those are all things that we've identifiedas some of the metrics we're looking at in ocular/vestibular, anxiety, depression, theusual metrics. but the key is what tools can we give them? do they actually use the tools?that'll be a metric. and do the tools actually help? and then when they come back in 6 months,we're going to re-image them to see if there's

actually an anatomical improvement. if weknow in traumatic brain injury, it's our hypothesis that there's a lot of these really small fibertracks that are broken. and can we show, which we've seen in other patients that we've demonstratedthis high definition fiber tracking on, you get this re-growth if you will. some of thesefiber tracks and areas of the brain. and so if we know that this area of the brain hassignificant fiber track breakage, can we provide tools that will improve that part of the brainthrough a variety of cognitive tests let's say. and when they come back in 6 months,the other metric would be is there actually significant changes anatomically in the brain?now that's really, that's a hard thing to prove. but the high definition fiber trackinghas been gaining greater and greater confidence.

we're working with radiology specialists athopkins, penn, baylor. we've got a strong academic community we're working with nihon this particular imaging modality. and so that's a big metric as well. we're not surewhether that metric i.e. the brain actually changed anatomy as a result of this intervention.an intervention on ocular, vestibular, cognitive that the patient actually demonstrated thatthey used on a regular basis. and so those are some of the metrics we're looking at. [wendy nilsen] that would be cool. [dr. poropatich] yeah! [wendy nilsen] so, some of my data friendsare asking questions one is "do you store

all of the data while it's being generated?"and then the second part of that is "how does the data that you're generating get uploadedto the, how does it, if it does, get uploaded to the mod, the electronic medical record?" [dr. poropatich] yeah, right now it sits ona dedicated server. so it's not being uploaded, it's a research server. so what makes it hipaacompliant, it's secure, in other words it's encrypted both upstream and downstream. it'sat least 256 des encryption, digital encryption system. it's sitting on a dedicated serverand it's password protected. so we have all the data sitting on a research server onlyand nothing is being shared on the patients electronic medical record, nor are institutions'emr. this is strictly a research project.

[wendy nilsen] okay, and then what kind of,what types of data are collected from your physical activity monitors? they're usingthe cell phone's accelerometer? [dr. poropatich] well they get a fitbit, forexample so we're all going to get a fitbit. so we're going to be looking at steps, howmany steps did they take in a given day? the same data you get from your fitbit activitywith sleep too. that's going to be primarily the fitbit providing the activity data elementsif you will. [wendy nilsen] i'm interested in the discussionof your ptsd with the sleep. what is the, you said you had sleep tactics? i mean therewere several things on the slide so it sort of quickly went by me. but the problems thatpeople have with sleep, with insomnia, with

nightmares and what are the therapies thatyou're using? or i didn't even know there were sleep tactics, that's a whole new thoughtfor me. [dr. poropatich] yeah, dr. anne germain offlorence is the key investigator for our sleep portion and she now runs the whole sleep researchlaboratories at the university of pittsburgh out of the western side institute there. andanne has got, and has developed and validated a lot of these tests. i don't know enoughabout them in great detail to tell you that if someone's having a nightmare, this is whatwe do to help prevent further nightmares or to help them through that difficult time.anne has published quite a bit on that primarily in a military population. and again her lastname is germain and i can certainly get that

kind of information and share it with you. [wendy nilsen] yeah, you said i guess yousaid the slides are available at the end of the talk? [dr. poropatich] yes, i'd be happy to sharethe slides. and again those slides are a contribution of all those people who i acknowledged allcontributed to these slides, so it's a real team effort for team tbi. [wendy nilsen] team tbi is a real team soi will, for those of you on the call, i will be sending out a pdf of the slides afterwardsand they also include dr. poropatich's contact information, so as you can see he's a greatteam player. so if you're interested in some

of the things that he's working on, i'm sureyou can contact him. so i think we're good for questions and i really appreciate dr.poropatich. i can't tell you how thrilled we are to have you back in d.c. even if it'sonly for a webinar. but this is the end of today's mhealth webinar series, distinguishedspeaker series at nih. please join us again next month when we're going to be having awebinar with our colleagues at fda on the mhealth guidance. so thank you very much. [dr. porpatich] thank you.