**Transcript of Cyber Seminar**

**Mild TBI Diagnosis and Management Strategies**

**Computer based cognitive training in a military based population**

**Presenters: Kate Sullivan, M.S., CCC-SLP; Wendy A. Law, Ph.D.**

**March 27, 2014**

*This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact**Wendy.A.Law.civ@health.mil**or**kate.sullivan05@yahoo.com**.*

*Dr. Ralph DePalma:*It’s a pleasure to introduce Kate Sullivan, who’s the Director of the Brain Fitness Center of DVBIC and Traumatic Brain Injury Service at Walter Reed and Wendy Law, a Clinical Neuropsychologist on the, TBI, Traumatic Brain Injury Service at Walter Reed.  They will discuss their ongoing work on computer-based cognitive training in a military population.  Thank you very much. 

*Kate Sullivan:*Thank you, Dr. DePalma.  

*Moderator:*I’m pulling up your slides right now so they should be up in just a minute.

*Kate Sullivan:*Okay.  

*Moderator: T*hen you can go ahead and advance once you see them.  

*Kate Sullivan:*Okay, great.  Thank you so much Dr. DePalma and Molly.  We appreciate it.  Wendy and I are excited to talk to you about our Brain Fitness Center at Walter Reed; tell you how it’s evolved over time and introduce you to some of our preliminary research findings.  Here is a disclaimer.  The bottom I want to highlight.  We are going to be talking about some commercially-based programs, and just to let you know that we don’t endorse them and neither Wendy nor I had any financial relations with them.

Like I said, we just want to tell you about our Brain Fitness Center at Walter Reed and about our population and some of the research that we have started in the Brain Fitness Center, but first I wanted to get an idea, we were curious as to all of you out there, what your experience is with brain training programs that have emerged on the market in the last 10 years, so no experience, some personal knowledge or experience or you are using them with your clinical population but on a limited basis or using them on a regular basis.  

*Moderator:*Thank you, Dr. Sullivan.  It looks like the answers are streaming in, and we’ll give people some more time to get their response.  Just simply click the circle next to your answer, and that will tally up.  Looks like we have a pretty good split here.  *[Cross talk]*

*Kate Sullivan:*Yeah, a nice wide variety.

*Moderator:*Yeah.  Looks like just over half of our audience doesn’t have experience with recent brain training programs.  About 20 percent have personal knowledge or experience but haven’t used or recommended the use of these programs in the patient population.  About 25 percent have experience using and recommending programs with my patient population but on a limited basis, and about seven percent report use and/or recommend the programs on a regular basis.  Thank you to our respondents. 

*Kate Sullivan:*Thank you.  Good to know.  Then the next question is just to get an idea of based on some of the literature as well as the professionals who are using these programs or not using them, what are the number one professional criticisms regarding these programs, just to get your ideas.  

*Moderator:*Don’t be shy to respond.  We cannot *[cross talk]*.

*Kate Sullivan:*You can choose more than one.

*Moderator:*Oh, yeah.  Thank you.  You can select all that apply, and these are anonymous results so you won’t be admonished for clicking the wrong ones.  

*[Pause]*

*Moderator:*Great.  Looks like about 20 percent of our audience have clicked not theoretically grounded; eight people have said inability to reach wide-ranging patient populations; six people have replied too complicated for most patients, and two people have replied professional involvement is not necessary.  Thank you again. 

*Kate Sullivan:*That’s interesting, and we’re actually going to ask this question again at the end of our talk and just see if the percentages change at all.  Walter Reed, we began the Brain Fitness Center at the original Army Medical Center, and then many of you might know that we merged with the Bethesda Naval Hospital during the BRAC, and so now we’re Walter Reed National Military Medical Center.  During the time, about 2008, when we realized we had a high influx of patients coming back from the wars over in Iraq and Afghanistan, and some with traumatic brain injury and some with subjective complaints of cognitive dysfunction on campus for long periods of time, whether it was there for amputee care or for going through their medical boards, we realized we needed to offer more to these individuals and more avenues, especially when it came to cognition and resources for rehabilitation.  

The idea of the Brain Fitness Center came from a neuropsychologist and another physiatrist we were talking to said, “You know, if someone’s going through physical therapy, they can go to the gym independently and continue to work out,” and we wanted that kind of a brain gym for all of the individuals that were staying as service members at Walter Reed.  We thought long and hard and why did we come up with computers and the computer program?  Well even back then, there was this emerging literature on neuroplasticity, that the brain can change and can be strengthened when given the appropriate exercises.  

There was this theoretical basis that many of the programs were designed upon, and although the literature wasn’t very strong at that point and still is just emerging for its use in traumatic brain injury, we thought there was enough to actually explore the use in our population.  We also realized if we could provide more reps, like going to the gym, it was going to help our providers, the occupational therapists, the speech language pathologists who were doing the traditional cognitive rehab, and they could focus more on those functional goals using compensatory strategies and such.  Then they began to use us as more of homework, so they would see a patient twice a week, and they didn’t have either the resources or the patient didn’t need necessarily one-on-one therapy more than that, but if the family members or they wanted to do more, we could become that homework as opposed to paper and pencil tasks and being that structured supportive environment.  We are a room with computers.  It’s just a computer lab.  Individuals come in and they sign in, and they fill out a form.  They put their earphones on, and they’re working independently.  

Kind of like a gym when you sign it and they get their free gym membership and they use as much as they want, and it’s independent use.  These programs, another reason they’re using computers is they can provide us adaptability, intensity and engagement that we think our service members were going to benefit from.  I’ll talk a little bit more about that and why they’re important in these programs.  Then we wanted something that once they’re discharged back into a remote location or even some that were going back to theater, they could continue their use.  These computer programs seem to be a nice avenue for that, so that patients could use them no matter where they were.  It was easy for access.  

Then we began to have a lot of questions.  These programs were commercially available, and people were hearing about them on the radio and seeing them in stores.  We thought that if people are going to use them, we’d like to be able to help in some way.  They could become educated consumers and use the programs that were best for them.  Like I said, we became a computer lab, a gym, a library of sorts with a lot of different brain-training programs that were commercially available and to become an adjunct to the therapeutic rehab team.  We are part of the rehab team.  We go to the rehab rounds now, and we’re very involved in trying to help the patients and meet their overall rehab goals.  We wanted to have clinical education, and then obviously start to answer some questions like, “Is this stuff even valuable?  Is it working?  Not working?  Which programs might be better?  Are there some that are going to respond more to these programs than others?”  We expanded down to Fort Belvoir during the BRAC, a lot of our service members and our staff went down to Fort Belvoir when we moved over to Bethesda.  

Then we started doing some research protocols, which we’ll talk about a little bit more.  We’re continuing to try to figure out, to adapt to this population in this setting to see if this is really appropriate, to see if we can do intense brain-training drill work in this setting.  Folks at Walter Reed, these service members are getting a lot of testing, whether it’s neuro psyche, OT, speech.  We did not want to become another diagnostic center.  For those reasons, we had to choose carefully what we were giving the service members at baseline when they originally came in, and then what we try to do is about every 8 to 12 weeks or when they switch computer programs, we like to give this battery.  It’s mostly subjective self-reports.  We decided to really look and see if they perceived an improvement, if they felt they were getting better by using these computer programs.  That could be just as important or maybe even more important than a standard deviation on a neuro psyche test, just to see if they were more confident and felt a little more empowered that they could do something when they were discharged.  

We do have an objective.  We use the ANAM [Automated Neuropsychological Assessment Metrics] that’s our objective cognitive assessment, and it kind of goes with our computer-based—it is a computer-based assessment.  Then we give a before-and-after sheet to every service member every day, before and after they actually do their training or they’re working on their exercises.  It’s just a short thing.  Is there any pain, self-esteem, and some insight into how they’re feeling they’re progressing.  These are the programs we currently have available at Walter Reed, and once again, we don’t endorse these specific programs.  There are a lot on the market, some very, very good programs.   When you look into some of them, there’s more research on some more than others.  

In general, what we tried to do was come up with a library of programs that we feel anyone could come in, depending on their severity, their diagnosis, their comfort level with computer programs and actually use of computers, that they could find something.  Many of the programs are specific to a cognitive domain.  As you can see, the Cogmed is to working memory.  The Posit Science, you can see one of the classic programs, the auditory processing and the insights of visual processing, those were software that you kind of can’t find anymore.  We still have a remaining stack of them.  They combined those two programs in the bottom left.  Hold on.  I have a pointer.  Am I pointing?  The combination of this program and this program is now a web-based version called Brainhq.  What they did was added executive functioning, specific to traumatic brain injury.  

Now this is has come from what was specific cognitive domain to now more of a cross-trainer that you can pick courses, similar to Lumosity.  A clinician could get in and say, “Okay.  I actually want you to work on the program that would be for listening in a noisy environment, and that’s the one I want you to focus on first.”  The clinician help aid it or they can choose on their on.  Once again, very independent.  Those are the programs we currently have.  

I often get the question, “Well, I don’t have the money to build a full library.  If you could pick one program, which would it be?”  I just can’t answer that because it’s interesting, when patients come into the Brain Fitness Center and we do our evaluation, which is getting history and talking to them about their cognitive complaints, sometimes we try to predict which computer program.  They go through and they do demos of all of them and say, “Oh, that person’s definitely a Posit Science,” or, “He’s going to love Dakim,” and honestly, we’re almost always wrong.  *[Laughs]*  It’s really tough to figure out.  It’s a personal decision, and so it’s really nice if you can at least go on—a lot of the websites have demos and show patients what’s out there, and they can become an educated consumer and part of that decision-making process.  You want to make sure that it adapts, the computer program is dynamically self-adjusting for the patient so that they are being pushed to be trained at an appropriate threshold.  The analogy of the gym, once again, is you could go every day and walk and never increase the incline or the speed on the treadmill or increase your weights, you’re not training at a threshold that is going to push improvement for you. 

The nice thing about computer programs is it can do it in real-time and see how you’re doing on accuracy as well as efficiency of answering and push you in a direction.  Some actually will do that in between cognitive domains, like that Dakim program.  It recognizes Kate Sullivan is back and says, “Well, we know we can only push her so far in math, but man, her short-term memory is great.”  Within cognitive domains, it can push people so they’re not as frustrated.  Intensity, and that goes back to that theoretical basis of neuroplasticity that the intensity has to drive real change, so those reps, and to be able to provide an intense amount of reps in a short period of time.  Once again, it’s hard for a therapist to do.  I’m a speech pathologist, and I know it’s hard in a 20-minute session, how many reps can someone do to improve, and the computer programs do a really good job at that. 

Then engagement, they have to want to stick with it, and so for compliance, they’ve got to like it.  You do want to find something that has some entertainment value for the individual.  The feedback and rewards can be based on something of—the Posit Science Group and this Brainhq, they designed it after working with some of the people that worked on Angry Birds, and to be able to do well, you unlock the next level, like in Angry Birds, and it might be a rep or a mundane exercise, but people are driven, some people that are working on them are driven to unlock that next level.  They really want to know.  That could be the type of rewards or feedback for some of the more competitive folks that are working on these programs.  

I guess this is still here, sorry.  The BFC patient population, so who is coming to us?  We’ve had over 430 patients so far come through our Brain Fitness Center.  Some have shown up once and never come back, it’s not for them.  Some have stayed years, actually, using our programs and changing different programs and coming to see us.  All sorts of diagnosis.  Most TBI and of the TBI, most mild, but we have been able to find programs and serve those who have had moderate and severe brain injuries, mostly male, Army.  About split in the middle those more acute within one year of having a brain injury or stroke, whatever it might be, and those who are many years post.  

On average, and for varying reasons, we see people twice a week for about two months.  Most are also getting other therapies.  This is, once again, it’s always been our push to be an adjunct to the therapeutic services that we have.  Does it help us here at Walter Reed?  Yes, it is helping providers, and it’s helping patients in some way, the ones that stick with it.  We think there’s many ways it might be helping them and not necessarily traditionally changing cognitive performance.  For our providers, we have had a dramatic increase in referrals from all sorts of folks who are saying, “Wow, it’s really nice to have a place when someone has either kind of maxed out on rehab or never really fit the mold for traditional rehabilitative services, but they’re still saying something’s not quite right and everyone’s going huh, all right.  Well, you didn’t have a brain injury or you did and we’ve already given you a year of services, and I think you’re doing well.  You’re using your strategies.”  They still want to be doing something, and that’s a lot of times we get the referral.  Sometimes we get a referral just because people say, “We want them thinking about anything else, for even 20 minutes or 40 minutes, put headphones on, than what they’re dealing with in life,” that was one psychologist that refers to us.  

We know sometimes we can be a schedule-filler.  Folks are here for a long time and with not a lot of structure once their rehab services start to dwindle, but they still remain here.  It does provide a place to go and people to receive them, and they feel like they’re doing something independently for themselves.  This over here is just our numbers.  Walter Reed, 2012, this is patient visits per month, and you can just see 2013, the increase.  I can tell you we’re about here, 2014, so a lot of patients coming to us.  The demographics is changing a bit.  We noticed around 2011 that we had less TBI only patients coming and an increase in TBI comorbitations with psychiatric and TBI diagnosis as well as just psychiatric alone.  That’s our comorbid patients and psychiatric.  I think there’s probably a lot of reasons to explain that, probably for a different presentation.  

Once again, that’s the same showing you those three populations as well as the other types of groups that we do see.  This is hard to see, and it looks like the slide here got a little messed up, but in general, this is our satisfaction survey.  Most people are saying they agree, they strongly agree that they’re happy with the programs; they’re glad they did it; it helped their rehab process.  Then over here, actually, the next slide will be better.  We tell folks to just circle an area of cognitive functions, circle as many as they think were improved.  As you can see, concentration to attention is the one circled most often.  That was 101 patients that filled out this form, and they were allowed to circle more than one.  Eighty-seven of those patients said concentration, attention to memory.  Interesting enough, usually when people talk about computer programs, how they help, it’s like, “How does it translate?  How does it generalize into the real world?”  As you do note, that is the one that is checked the least amount.  I jokingly say, “No one comes in saying I want to improve my real world tasks.  They come in saying I want to improve my memory, concentration, attention.”  Sometimes after our conversations they say, “Oh yeah.  Well, I guess that’s real world.”  

Benefits and limitations of adding brain training programs in a military treatment facility.  I could have probably three slides on limitations and three slides on benefits, but what we’re finding for us is because we have it set up as an independent gym, they’re signing in; they’re putting their headphones on, is that they don’t have a clinician.  There’s research assistants that are in the room with them at all times.  We could have six patients at one time in there, and they’re just working independently.  That’s the way these programs were designed.  They were designed for home use and independent use, not necessarily with a clinician.  We’re trying to work on that and how we can better that.  

Perception it is enough.  Not only from patients but from providers.  Sometimes we’ll get a referral saying that we want them to come to the Brain Fitness Center for cognitive rehab and we go, “Well, let’s be careful with that.  This is not cognitive rehab.”  Then not knowing exactly which program and thinking that any program would work.  These patients are not at home.  They’re not stable, so the limitation of our setting, that they have a lot going on and there can be some low compliance.  It’s not structured.  

Benefits at Walter Reed that we’re finding is that we can help the other therapists focus on drill work.  The programs are mobile.  They are far-reaching for many patients when they leave here.  They’re low cost.  The Brainhq, Lumosity, those are less than $10.00 a month, so we usually give them a year subscription, they can keep using it.  They find it fun and engaging.  They like being independent and not having someone hold their hands.  It’s something new for them, and they feel empowered by that, and it’s novel.  These are novel patients, as we all know, and it’s kind of a novel approach, and they like it.  It introduces them to healthy brain habits and maintenance of use when they get home because they continue to use the programs, and we can follow their use once they leave. 

There’s limitations.  We’re looking for clinical more supervision, possibly, and goals, depending on the patients and where they are in their rehab.  Providing more provider education on the limitations of what we do and the limitations of our programs and specifically wanting to know more about the actual programs we have so they can send us referrals for specific programs.  They can actually know what we do and what our programs can do and cannot do, and trying to allow more flexibility and possible incentives to stick with the program.  

The last thing I’m going to talk to you guys about before I hand it over to Dr. Law is about our first feasibility study.  This was just a pilot study when we originally started the Brain Fitness Center, and I’m going to talk to you about not necessarily about the amazing findings, but all of our lessons learned.  What we did was we wanted to take the first two programs that we were using, the Dakim and the Posit Science, and see if there was any difference in the use of the programs and how patients perceived any improvements, seeing if there was a difference in any ANAM scores.  Then once again, is it all feasible?  Can we pull off these types of programs, these studies and really this clinic in this setting?  How did they feel about it and what was their attendance?  Did they comply?  

We were randomly assigning them to Dakim, Posit or a control, which was no computer program at all.  They were coming back in six weeks, and then we had so many individuals coming to the subjective reports of cognitive complaints that we wanted to do the same for that, but they did not fit the TBI criteria.  We had 290 Brain Fitness Center patients come through at the time between when our IRB approved it and when we closed the study.  One-hundred-twenty were eligible.  Only 38 consented.  Here’s our first problem.  We’d say, “Uh-oh, red flag here.  What’s going on?”  The number one reason given for not consenting was our control group, which was just standard of care.  They could not use one of our computer programs, not only for the six weeks, but for up to our 12-month follow-up. 

The people that were walking through our door wanted to use one of these computers said, “Well, no, I don’t want to take that chance.”  We had 13 with our Dakim, and we had 13 with Posit.  Only five completed the program, and six completed for both.  That was 11 total, less than half actually completed our program, which was five times a week.  We’re interested and we know a lot of times why they left, because they had to or they just couldn’t for any reasons, but we were concerned when they started to drop off.  We thought this was interesting when we looked at compliance.  It seemed to, and this is a low end, but it seemed to if they just got over this 10 visit hump, they seemed to finish it.  We said, “Gosh, is there something about this?  Was that when they started to perceive a change or realize after 10 visits to the gym, I’m actually feeling a little better; maybe I have lost weight.”  It’s not going to occur here, the first two times.  It’s actually frustrating and the computer’s getting to know you.  Man, if we get them over the 10, is this something that we should look into.  It was just something that we found interesting.  Most was the same as our clinical, they thought it helped and they enjoyed the process.  

The same satisfaction, they thought it was concentration, attention, and listening and memory were the areas they found improved the most.  The last thing is just kind of what we learned from this.  I think anyone who’s tried to do any research with cognitive rehab knows the challenges, but for this specifically, for computer-based programs, is that we needed to not just pull from the people that were coming to the Brain Fitness Center.  We had to actively recruit elsewhere, and we wanted to open up other sites to increase our pool.  

Our eligibility is a little bit strict in the number of traumatic brain injuries they could have.  Everyone was reporting at least more than one, and the sessions had to be completed in the Brain Fitness Center.  That was with the software.  We have now moved on.  Web-based tools is really where they’re all going, and we needed to have more flexibility.  This was a little bit too much, and then the standard of care.  Group C, which was come back and you can’t use any of them, we need at least a placebo or a waitlist control.  There had to be an incentive.  This is a lot to ask, every day for at least six weeks was a lot to ask.  

Now what are we doing when it comes to research?  We knew we had over 400 patients. Well, let’s look back into these charts.  Let’s take all of our clinical charts and see if we can make sense, and if we can answer any of our burning questions, which we have so many of by making a database.  Then we don’t want to give up our attempts to try a randomized controlled study, so let’s redesign it and move forward that way.  

Dr. Law is going to talk a little bit about both of these and give you some ideas of what we’re doing now.

*Wendy Law:*Thanks, Kate.  We’re switching seats here.  Give me just a second, and make sure I know how to work this.  Okay.  So as Kate was just saying, we sort of decided we wanted to look back into the clinical patient files and see if we could cull come of the information there to help us understand or identify which patients might benefit most from this type of program, who was participating most, what kind of outcomes we were seeing.  Initially, we did a chart review of the first 96 patients that participated in the brain fitness center.  In that first 96, we had 29 patients who had completed the three primary questions.  I’m not using the right arrow.  Excuse me.  The three primary questionnaires that we were interested in here.  This is a very heterogeneous population, and the procedures that were used varied widely across different participants.  As you can see, the visits were, on average, 29 with a range of three visits to 137.  Some of these people in whom we had pre-post data were as a result of three visits.  Even with that much heterogeneity and variability, we got significant improvements in the MAYO Portland Adaptability Inventory and in the Neural Behavioral Symptom Inventory, both indicating consistent with the satisfaction things that had been found previously.  

Satisfaction with life was not significantly different, but it went in the right direction.  We are not, by any means, attributing this to their being in the Brain Fitness Center, but this is our first attempt to see whether or not looking at the clinical patient files and pulling that data out would provide us any useful information.  This figure is showing what I just said a minute ago about the number of visits that varied widely in the first 29 patients that we had pre-post data on.  There were also eight patients who were using at-home computer programs, so we don’t really know even how much they were doing.  It gave us enough information that we saw a reduction in symptom severity, suggesting that improvements may generalize beyond just the task itself because they were talking about improvement on self-report questionnaires of symptoms, and they are symptoms that are really very high face validity.  There’s no subtlety in these measures.  Certainly other factors beyond the brain-training content of the computer programs likely contributed to changes, but again, we had such wide variability in the number of visits and the type of patients and saw this change, it at least led us to decide to look at this in a more thorough way and actually formally develop a database.  

That was our next step here was developing a formal database out of the clinical information with the demographics, clinical data, all of the information we could cull from the clinical files and, again, one of the questions that we’ve had from the outset is is this type of software approach to cognitive retraining useful, and how does it apply for our population here, the military population who are on the base getting treatment.  We also thought that once we looked at this clinical database, it might help us to develop hypothesis-driven protocols and help us understand patient characteristics to predict who may or may not improve in using this. 

The rest of the research that I want to talk with you about is preliminary findings that we’ve done.  The database is still very much in the production phase.  We are transferring clinical data to a formal database so that we can look at this more systematically, and it is an approved IRB protocol to do so, but it’s very laborious, so we’re still in the process of translating that data.  The data I’m going to present now are on what we’ve so far been able to put into the database.  This first one, one of the questions we had was if we’re saying that these cognitive retraining programs are going to improve cognition and also hopefully improve the symptom report, which we’d already seen some benefits from or seen some suggestions of, then what is the relationship between the cognitive performance and the symptoms before this even starts.  

What we did first with our retrospective chart review was looked at patients’ performance on the A&M.  We used the efficiency measure because it’s a nice global way of capturing overall performance and compared it and correlated it with symptom severity on the neurobehavioral symptom inventory.  We did it in two ways.  We looked at it overall with anybody that we had both of these measures for at baseline, and then we also looked at it in the sample that was only concussion, contrasted with those other patients who were anything but concussion, including moderates and severes.  Concussion versus all others, and then we also, in addition to the correlation between those two measures, we looked at a median split of the high symptom endorsers and the low symptom endorsers to see if the way that they performed on the objective cognitive testing was different.  We wanted to find out if we had different populations in the patients who were endorsing a lot of symptoms and those who were not.  

Here’s the basic patient demographics of that 97 patients that we had baseline data on both of these with.  I can’t get my arrow now, just a second.  Well, it looks like I messed that up.  Excuse me.  I’m sorry.  I can’t use the arrow anymore.  I messed it up.  Oh, there it is.  Thank you very much.  This is the same basic demographics that you saw before.  It’s a little bit different with this sample just because of the patients that happen to be put into the database already, but it’s basically the same.  Our not MTBI sample, let me just go back and look at that again for a moment, what we see here is that 45 of this sample were our concussion group.  

Of the 97, 45 were concussion.  On the not concussion sample, we had a percentage that were TBI but not concussions and then others who were not TBI at all.  Of that sample, it was about a third psychiatric, a third other neurologic and a third physical injuries, trauma below the neck or peripheral sensory deficits, and then three that we didn’t particularly know what they were with regard to their actual reason, but we knew they were not concussion because that’s monitored very carefully here at Walter Reed. 

This is the total sample, the 97 that we started with and then our two subgroups, concussion versus not concussion.  The primary measures over here that just give the means and standard deviations.  The first thing we did was correlated the objective performance on the ANAM with the total symptoms endorsed on the MBSI, and we looked at the individual subtest on the ANAM and also the average throughput efficiency across all of the tasks.  What you can see is that with the whole sample, we have good correlations between the subjective symptoms that are being recorded and lower efficiency, so more symptoms, less efficient cognitive performance on the overall sample.

When we look at this with regard to the concussion versus the not concussion sample, we see that the concussion sample does not show as strong a correlation between objective and subjective symptoms.  The highest was actually for the first simple reaction timed task, and we’ve seen this before in the literature with regard to concussion patients, but also the overall ANAM efficiency and for some reason, this matched the sample test.  I don’t have a clue about that right now, but the numbers are the numbers.  However, with our overall not concuss sample, and the numbers are quite similar so we don’t think this is a statistical artifact, all of the measures continue to show very significant correlations with symptom report and decreased cognitive efficiency.  That was our first clue.  

Then we looked at let’s take this number of symptoms reported and look at the high endorsers versus the low endorsers.  Is there a significant difference in these two groups with regard to how efficient they are?  What we see with our overall sample is that the simple reaction—and we just looked at simple reaction time one and the average ANAM because those are the two that were consistently across the two groups that made sense.  In the simple reaction timed task, clearly the low reporters are much more efficient than the high symptom endorsers.  The same thing with the ANAM overall throughput.  Both of these were statistically significant.  

When we look then at our subgroups, we have our concussion sample, and we see that while the direction is appropriate for the changes between the high and low symptom endorsers, neither of these were significant, these simple reaction times and the average throughput were not different between high and low endorsers.  What this meant is that regardless of what the concussion patients were complaining of, it was not as clearly related to the actual performance on the baseline cognitive measure.  

In contrast, again, our not concuss sample over here, both measures were significantly different with the low symptom reporters being much more efficient than the high symptom reporters.  This is our first indication that there was something different between our concussion and our not concussion sample participating in these programs here at the Brain Fitness Center.  

From this particular initial study, and again these are preliminary, this is our first effort at looking at the database information that we had in, what we’re seeing is that within our military patient population, the subjectively reported symptoms are associated with objective functioning overall in the mixed sample, but there’s an unclear relationship in patients who are specifically concussion without the other factors or with comorbid PTSD, but that have concussion is the main reason they were referred. 

That tells us that there have to be factors other than neurocognitive functioning that are contributing to symptom persistence as they’re describing it and reporting it.  What we also want to find out from this, and again the main reason for doing it is to try and understand which of the patients are likely to benefit most from these types of programs.  We certainly know that there are going to be patient factors that we’re not aware of at this time that need to be investigated further.  It may well turn out that patients who not have a clear association between objective performance and subjective symptoms, they may be less likely to benefit or they may show improved cognitive functioning from the training but not show reduced symptom reports.  These are things we’ll be able to look at as we continue to build our database and work with this population.  

Clearly, there are significant limitations in this retrospective chart review.  It’s an initial effort for us to try and understand factors that might help us predict who’s going to benefit, if they are at all.  Future direction suggested from this that we should be looking at patient factors that could impact outcome.  These could include things like premorbid risk factors and vulnerabilities, for example, prior diagnosis with Attention Deficit Disorder before coming into the military.  Also, performance validity factors, is this something that’s going to help us understand who’s going to benefit from a performance in these measures. 

Our next step, which is, again, even more preliminary than the one we just talked about, is we took our prior findings.  We had the retrospective study results where we saw significantly improved subjective symptoms on the MAYO and the MBSI scores and suggested improvement in satisfaction with life when we looked at the overall clinical sample.  That was following cognitive retraining, but we didn’t associate any of those.  We just looked at pre-post changes in those measures for those who had done some of the training for a consistent period.  

In the study I just described, we saw that the ANAM performance efficiency was related to symptoms in the mixed clinical sample, but it was unclearly related in the concussion-only sample, so we needed to consider other factors.  This next study is a descriptive study, very preliminary and was designed to examine the role of performance validity on symptom changes, and improvement specifically, following cognitive retraining exercises. 

What we did with this was examine pre-post changes in our symptom scores for the mixed clinical patient sample and for each of the two subsamples that we’ve been talking about, the concussion and the not concussion group, in relation to patients who have ultimately in relation to those having valid ANAM performances at both of those visits.  In order to do that, we had to have completed ANAMs at the two sites, and we had to review the files again to find out who we had pre-post ANAM testing results on.  

Well, Kate had already mentioned that we had the BRAC where we integrated Walter Reed and Naval Bethesda, and unfortunately, at that time, many of the computers that had ANAM data at old Walter Reed were scrubbed clean, and somehow that data got misplaced, which is horrifying for us because it was really good information that we’d like to have.  As a result, we don’t have anywhere near the amount of ANAMs that we do as we have some of the other information.  When we looked to see how many of these patients had actually completed two ANAM assessments, we only had 37 patients in our initial database.  This isn’t overall what we’ve been doing at the Brain Fitness Center, but what has already been put into the database.  Of those 37, only 14 were concussed, but that’s not unreasonable for the total sample.  

We also looked at—so that’s the first sample, this 37.  Then we took that sample and said, “Okay.  How many of those 37 patients had completed what we’re considering a minimally accepted intensity at the Brain Fitness Center?”  We defined that as 12 sessions.  It’s semi arbitrary, but it’s also based on, if you remember from earlier, that the cutoff of coming 10 times or more seemed to be critical for showing that patients were really committed to being here.  We used 12 as, “Okay.  If they came for 12 or more sessions, we’re going to look at what—,” and they had 12 or more sessions completed, “we’re going to call that minimally accepted intensity.”  Then we also wanted to only look at those patients who had a valid ANAM at both sessions.  That was our 18.  Just under half of our total patients who had two ANAMs had a minimum accepted intensity and valid ANAM.  It’s a little bit confusing, so I’m stumbling over my words, but I’m hoping you’re tracking what I’m saying.

This is, again, just the patient demographics of what we’ve seen before.  Our mild TBI sample of 14, and then we had 23 that were not concussed in the larger group, 10 of which were TBI.  This is a very busy slide, but I’ll walk you through it fairly carefully.  First of all, we had the total sample, the N of 37, who had completed two ANAM assessments, and we had the number of weeks, the total number of visits, and then the breakdown for the mild and the not mild TBI samples in each of these.  This is really just descriptive information.  It’s a very busy slide, but it’s showing the number of weeks between visits and the total visits in our two.  I’m going to call this the elite sample because it’s the one that had a minimum intensity and valid ANAMs at both visits, and this is our general sample, the ones who had completed two visits with ANAMs. 

What we did then was we looked at symptom changes with repeat Brain Fitness Center visits, that pre-post, and we first looked at the total sample that had two ANAM visits, and we see that there was a significant improvement in the MAYO.  There was a trend for improvement in the MBSI, it just was above significance here, but no significance in the satisfaction with life.  In fact, it looks like no change at all with this total sample.  Then when we turn to our elite sample, and this is the sample, again, I’m going to beat a dead horse, but this is the sample who had at least 12 visits at the BFC and on both the pre and the post visit had valid ANAM performances. 

In this sample, we had the MAYO and the MBSI significantly improved.  It’s a smaller N than in our larger group.  It’s not a statistical artifact.  We’re going the opposite direction, and satisfaction with life is showing the right directional trend, although it’s not significant, that may be a sample size issue, but it certainly is moving in the right direction.  

Then we wanted to look at the subgroups, our concussion versus our not concussion subsamples.  This is, again, based on the larger N37 of those who had two ANAM visits.  First of all, what we see is that our concussion subsample did not show any significant improvement in the MAYO, the MBSI or the satisfaction with life.  They look like they’re directionally headed the right way, but the variability is so high in these groups, these are really misleading.  Even with this one, this is the wrong direction for satisfaction with life from repeat visits.  

Our concussion sample, even at repeat visits, is not showing the same relationship that we saw with the overall sample.  If we look at our not concussion sample, we see that the MAYO and the MBSI total are both significant.  They show significant improvements with two ANAM visits, and again, satisfaction with life is not significant, but at least it’s going in the right direction.  Then, this is the slide that’s really very, very preliminary.  We only had three concussion patients who met minimal accepted intensity and had good performance validity on both ANAM visits.  When we looked at those three and did T-test comparisons, which is absolutely ridiculous from a statistical perspective, but did it just for fun, we did see a significant improvement in the MAYO and not a statistical improvement in the MBSI, but certainly the right direction and certainly not that on the satisfaction with life either.  

There is no way in the world that this should even be looked at statistically, but it was interesting when I just did it for fun, we did get the significant change, and we still got the directional expectations that we would expect to see for these questionnaires.  Finally, when we look at the not concussion sample.  Again, a very small number that we’ve broken down to.  This is our elite not concussion sample, but we see significant improvement in the MAYO; almost significant in the total symptoms, and again, the correct direction of change for the satisfaction with life.  

Again, these are our initial preliminary ways of trying to look at our clinical data and culling it into a database.  This is just the first subjects that we’ve been able to get into a systematic database to start looking at.  There was no selection to how we put these in.  It really is we’re going through the files and adding them in one at a time, and these were the numbers that were available when we did the analyses.  It’s certainly very encouraging to us that there’s something going on here.  We are not ready for prime time yet, but we’re certainly ready to talk about it as thinking that we’ve got something happening. 

Preliminary conclusions is that within this military patient population that are seeking computerized retraining exercises, they’re doing it because of subjective symptom concerns, and we do see, or at least these findings suggest, that symptom improvement is associated with the intensity of participation.  This is a very small sample, but again, if we look at this less than 10 versus more than 10 visits, we’re finding differences in completing research study and also in showing significant improvements in subjective symptoms.  

However, we also found that this is moderated to some degree by performance validity, at least on the ANAM task because when we removed the patients who were not valid, we were able to change the significance in the concussion sample, and even with an N of 3, which again, is quite ridiculous.  

Our concussion patients who did have problematic subjective symptoms and consistently demonstrated valid performance, maybe they’re the ones who are going to be most likely to benefit from these computerized retraining exercises.  We don’t know that, and we’re not going to limit it to that, but that’s a suggestion that comes out of this first look at some of the data that we’ve collected to date.  The limitations are, I think, very apparent.  This is a very small sample size.  The benefits are, I think, only that we didn’t select anybody.  This is really just putting the patients in and looking at what we have so far. Then we have our future directions, which we are going to move towards increasing the database, continuing to get more of the clinical information in so we can look at this with larger numbers and also start trying to hone in further to what type of individual subject factors may help us predict who is or isn’t going to improve or show benefit from these exercises. 

Now as Kate had said, the other thing we have done from lessons learned is try to develop new research protocols that will improve some of the changes that we had before.  The BRAVE Trial is the most recent research protocol that’s been approved that has tried to do this.  What this study does is first of all, it’s a multisite study, and what this is going to do by adding additional sites, it will increase the potential subject pool for recruitment so that the sample sizes can be more appropriate for really doing randomized control trials.  We also increase the inclusion criteria so there’s a broader opportunity for people to become involved, and then this study as a multisite perspective double-blind randomized trial is going to assess safety and efficacy. 

It has effectiveness of the program on cognitive and functional, endurance effects following the completion and also identifying specific populations of responders.  With this broader sample and increased criteria, it’s also web-based.  It’s not computer software, so it’ll be more flexible and have a broader reach again.  We also included an active control group that is involved in computer-based activities, whereas in the previous research, it was standard of care. 

At this point, what we’re thinking about and what we think about as we’re continuing to work with patients in the Brain Fitness Center are the pros and cons of this computer-based cognitive enhancement, and just as a review, the pros are really the development of these computer-based cognitive enhancement programs are theoretically grounded as we continue to gain knowledge in neuroplasticity.  Some of them actually have an empiric-base behind them now because research is gradually starting to be developed, but most of them are actually advertising based on their theoretical basis for being beneficial.  They are very much able to reach and provide adjunctive services to patients in remote locations who maybe have a harder time reaching daily rehab programs and maybe can only go once or twice a week and can use these further away.

In contrast to what most of us might think, these types of programs really are easy for almost all patients to utilize, with the exception of the very young and the very severely demented.  That’s one of the advantages to these types of programs.  They need a little bit of introduction, but they really are quite accessible and easy for most patients, almost all to use.  There is also—and this is a pro, there is limited evidence that there are some transfer effects beyond the training tasks.  Some cognitive domains seem to do better than others.  For example, attention seems to be more benefited than language skills.  There’s not a lot of it, but it’s limited evidence and it’s, I think, continuing to grow as more research is being published. 

Cons against the computer-based cognitive enhancement, the same thing, limited empirical support so far.  Most of the empiric support has very small sample sizes.  There are a lack of adequate controls; the generalized ability outside of the task itself isn’t certain, and these are all things that are criticisms of the use of these programs until they are more well-established.  They also may prevent or reduce engagement in evidence-based rehab services that focus on compensatory training strategies.  Again, we address that here by being an adjunct service and trying to help educate non rehab providers of how this can be used to assist with traditional rehab programs that the patients are involved with.  

The biggest contrary is that professional guidance is not required.  These programs are available.  Patients can go online and pick one up and use it.  There is no professional oversight required.  We here try to have some professional oversight to make sure that the programs are being used appropriately and by working with other professionals, but out in the community, there’s a lot going on that isn’t.  

Finally, much of the existing research that has been offered is by the program developer, so they have a vested interest in having this be useful.  We’re going to go now again to the poll that we started with at the beginning.  Can we pull that up?  

*Moderator:*Yes, pulling that up right now.

*Wendy Law:*Thank you.  

*Moderator:*Okay.  Go ahead and open that up.  There you are. 

*Wendy Law:*This is the same one we asked about earlier, and we just want to get a sense based on the talk if there have been any changes of professional criticisms regarding computer-based training programs. 

*Moderator:*Thank you.  It looks like we are seeing quite a difference in the opinions, so we’ll let those answers keep streaming in.  Remember, folks, you can select more than one option. [Pause] All right.  

*Moderator:*Okay.

*Moderator:*Well, we have some trends here.  It looks like about 12 are saying it’s not theoretically grounded, about four inability to reach wide-ranging patient populations.  No one is saying now that it’s too complicated for most patients, and about 15 say professional involvement is not necessary.  

*Wendy Law:*Right.  This is sort of the take-home message that we wanted.  The not theoretically grounded, that’s a bit of a controversy.  There is some theoretic basis because they’re based on what we now know about neuroplasticity, but we don’t know as much about neuroplasticity as we might wish.  That certainly does make sense.  I’m going to turn this back to Kate now as we go to the end. 

*Kate Sullivan:*I just wanted to acknowledge the PI in a lot of our projects and the head of the Traumatic Brain Injury Department here at Walter Reed, Dr. French, Dr. Mike Pramuka who was at Walter Reed for quite some time and has just left us for the Tamp VA and our research assistants who we could do none of this without, they’re fantastic, Alanna, Laura and Angela.  We wanted to recognize them.  References, if you need them, for some of the stuff we talked about.  Some of the websites for the programs we talked about, and Sharpbrains is just a fun—it’s almost like a blog, it’s a fun website to follow, and they always put new articles and trends on neuroplasticity and these computer programs, if you’re interested. 

Then we can open up to any questions. 

*Moderator:*Excellent.  Thank you both so much.  For our audience members, I know a lot of you came in after the top of the hour, so to submit your question or comment, use that Q&A box that’s located in the upper right hand corner of the screen and we’ll be able to get to those.  Okay.  We don’t have any pending questions at this time, but we’ll give people a couple of moments to get their questions in, and for our attendees, please do stick around because in a moment, I’m going to put up our feedback survey.  We’ll want to get your feedback for this presentation and also find out what other subjects for the TBI series you’d be interested in hearing more about.  No questions have come in yet.  If either of you want to give some final comments, feel free to.  Wait, sorry.  I’m going to cut you off already.  It looks like somebody wrote in saying, “Please clarify ANAM changes,” so ANAM.  

*Wendy Law:*Thank you.  The ANAM is an automated computerized test that provides reaction time and accuracy measures across a variety of subtests and then overall.  What we looked at in this study was an average efficiency, which is the ratio of the number of correct responses per unit of time.  It’s in the millisecond range because it’s computerized.  It allows us to do some very precise comparisons of cognitive processing efficiency by the individual tasks and overall.  The measures that I focused on in looking at the results was the simple reaction time because the concussion group, that was the strongest correlation they had with symptoms, and then the overall ANAM efficiency because it’s a good summary measure of cognitive processing efficiency. 

*Moderator:*Thank you for that reply.  The next question we have, “Thank you for the presentation.  I noticed that Brain Train was missing from your library.  Any particular reason?”  

*Kate Sullivan:*Sure.  Brain Train is not—was kind of developed prior to this group of programs that we’re looking at, kind of those neuroplasticity-based.  I think Brain Train is almost always used with a clinician, and these are more the independent commercially available programs. 

*Moderator:*Thank you for that reply.

*Kate Sullivan:*Sure.

*Moderator:*“Do you compare brain fitness programs?  Do you have any plans to do so?” 

*Kate Sullivan:*Did you say compare brain fitness programs?  

*Moderator:*Correct. 

*Kate Sullivan:*That actually was originally what we were trying to do with that first study, and yes, we would like to, once we get this database in, retrospectively is to go back and see if there’s any difference, even in compliance for some of these programs if we’re seeing a trend towards one type of program over the other or with different patient populations, if one responds more to a type of program than the other, and obviously, if they perceive it as one improving an area. 

Often, it’s interesting, our patients if they stay here with us long enough, about 12 to 14 weeks in, they’ll be looking over their shoulder and saying to someone else, “Hey, I really like this program, and I continue it, but can I try that one now.”  We kind of wrap up with one and give them our post surveys, and then they’ll move on to another one sometimes.  They’ll tell us—and they’ll compare them.  They’ll say, “This helped me with this, but this one really seems to help me with some other domain,” which is interesting.  Yes, we’d like to know.  

*Moderator:*Thank you.  The next question we have, and you may have just touched on this, “Did these improve with various programs?  Can you choose a program to test?” 

*Kate Sullivan:*Do you understand? 

*Wendy Law:*I’m not sure if I’m understanding the question, but the data that we looked at is collapsed across all of the programs, so we haven’t looked at any specific individual programs yet.  Again, they’re very heterogeneous programs to choose from and also the population itself.  I’m sorry, what was the other part of the question?  There were two parts. 

*Moderator:*Can you choose one to test? 

*Wendy Law:*Once we have our database completely complied, that’s one of the things that Kate was just saying, we want to go back and see if there’s differences in compliance.  Patients who choose this program are more likely to stay with it than the others, but we’re still putting that database together at this point.

*Moderator:*Thank you.  I do have a couple more questions pending. I’m going to continue doing the Q&A.  In the meantime, I’m also going to put up the feedback survey, so for our attendees, please take just a moment to start filling this out.  I’ll also continue on with the Q&A.  The next question, “What free cognitive resources have been recommended?”  

*Kate Sullivan:*Everything that we talked about, there’s none that are actually free.  However, I would strongly suggest if your patients are interested, there’s usually about a free month or a lot of free exercises that you can go on to these websites.  It’s a real neat way that if you happen to have a patient in your clinic that you could go through on Lumosity or Brainhq and you could go, even Dakim has games they can use, and you can try to figure out between what their complaints are and what their comfort level with these programs and see what you could find.  There are some brain training apps out there, but they’re not quite the same, but they’re probably for free. 

*Moderator:*Thank you.  The next question we have, “Comorbidity of substance use with PTSD, were these patients also included?” 

*Wendy Law:*We are starting to look at the various comorbidities that our patients have, and we didn’t exclude anybody.  In general, substance abuse in our sample tends to be more alcohol, not always, but tends to be more alcohol.  That certainly is a factor that we’ll need to look at more carefully.  Again, this was a very preliminary first look, and we selected the variables that we wanted to evaluate, which was mostly concussion versus non-concussion and then whether or not they’d had the correct number of sessions to say minimally accepted engagement in the programs, but definitely substance abuse is a factor that we know to be important in any aspect of function and we’ll be looking at more of these other comorbid concerns as we get the database into better shape for our sample sizes.  

*Moderator:*Thank you.  We do have just a couple of questions left.  “In regards to intensity, five times a week seems excessive for many of the outpatient population. Do you have a minimum amount of activity that you would recommend?” 

*Kate Sullivan:*That’s a great question.  The reason why we originally had five days a week was because of the larger study which was actually done by Posit Science, the active study, they had five days a week.  We were basing it on some of that early literature that did show some evidence for improvement.  Not only are we developing over time, but so are the producers with these companies in speaking with them.  It’s usually about a three-day a week and interestingly enough, they say consecutive days is now starting to pushed more than putting breaks in between the days.  It really also depends on the patient and what you’re trying to achieve.  If you’re just trying to get them into some healthy habits of using their brain and obviously, they can take up knitting or foreign language.  There’s a lot of other things they can be doing, but if this is just something that they’d like to do or if it’s more in rehab in a specific cognitive domain that you want more intensity, you might push a little bit more use.  That original three-to-five days a week for 8 to 12 weeks is still kind of a standard to show real change in neuroplasticity-based work. 

*Moderator:*Thank you for that reply.  This next question was follow-up to testing any one specific program.  “Wouldn’t that need to be done to get an adequate N, any guess?”  

*Wendy Law:*Yes, and I think that’s what some of the research studies, the randomized controlled studies are designed to specifically evaluate and compare different tests with each other using an adequate sample size, if I’m understanding the question.  I’m sorry if I’m missing the point on that.  Thank you.

*Moderator:*No problem.  They’re more than welcome to write in for further clarification.  That is our final question at this time.  Would either of you like to give any concluding comments? 

*Kate Sullivan:*We’ve given our contact information.  If you have questions that we weren’t able to answer and if we rushed through some stuff, you’d like some more clarification, please let us know.  We’re trying to figure this out ourselves, how to utilize these programs to make rehab more efficient.  Any suggestions, too, I’d love some.  If you guys have experience and are seeing something, we’re making this up as we go and with what we know, so any advice from around the country would be welcome. 

*Wendy Law:*The research findings we discussed today, again, these are very preliminary, but we find them kind of provocative.  We think it’s very suggestive that we’re at least doing something positive for these patients regardless of what’s causing it at this point.  

*Moderator:*Excellent.  Well, I very much want to thank you both for lending your expertise to the field.  We have had many people write in saying thank you for such a terrific presentation and they’d love to hear follow-up from you.  I also, of course, want to thank Dr. DePalma for organizing this presentation as well as all of the other ones in our TBI series, and of course, thank you to our audience members for joining us.  I am going to leave the feedback survey up so please do give us your input.  It’s your opinions that help guide which sessions we schedule.  Take your time on that.  I will leave it up, and with that, I just want to thank Kate and Wendy again, and everybody have a wonderful day.  

*Kate Sullivan:*Thanks, Molly.  

*Dr. DePalma:*Thank you all. 

*Moderator:*Thank you.  

*[End of Audio]*

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