**Transcript of Cyberseminar**

**Mild TBI Diagnosis and Management Strategies**

**Crosswords to computers: Evidence base for mild TBI interventions**

**Presenters: Heather G. Belanger, PhD, ABPP-CN, and Amy Jak, Ph.D.**

**January 22, 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: Amy Jak at**ajak@ucsd.edu**or Dr. Belanger at**Heather.Belanger@va.gov*

*Dr. Ralph DePalma:*It's a pleasure today to have a provocative presentation, certainly of great interest to all treating MTBI.  Heather Belanger will speak on—the title is Crosswords to Computers, utility for treating MTBI.  She's an attending neuropsychologist at the James A. Haley VA and associate professor at South Florida.  Amy Jak, also a neuropsychologist and director of the TBI Cognitive Rehab Center at the VA in San Diego and assistant professor of psychiatry at UCSD, will also go on.  We are looking forward to 20 minutes of questions and comments at the end of the conference.  Thank you very much, Molly.

*Moderator:*Great.  Thank you, and we'll go ahead and turn it over to you, Dr. Belanger.

*Speaker:*Well, hello.  Here we go.  Hello, everyone.  My name's Heather Belanger.  Again, I'm from the Tampa VA.  I'm going to first be talking about interventions for post-concussive symptoms, so that will be my focus, and then Dr. Jak will talk about computer-based cognitive training programs, so her focus will be a little bit different.  These are my views.  Briefly, I intend to define TBI, talk more specifically about mild TBI and recovery, review non-medication approaches to treatment for postconcussive symptoms, or PCS for short, present some preliminary results of a trial that we're just wrapping up here in Tampa, and then some conclusions.  

First a little interactive poll question, though.  We'd like to know to what extent you're interested—in what capacity you're interested in mild TBI.  Is it as a clinician, a researcher, a clinician-researcher, a manager, or other?  Please go ahead and select the appropriate option.

*Moderator:*Thank you.  It looks like we're getting a great response rate, so thanks in advance to our audience members replying to us.  Looks like the majority of our audience, about 58 percent, are clinicians.  About 10 percent identify as researchers, about 18 percent as clinician-researchers, and 4 percent as manager or policymakers, and 6 percent say other.  Thank you very much for those responses.

*Speaker:*Okay.  Back to the slides.  First, in brief, what is a traumatic brain injury or TBI?  This is likely a review.  A TBI is defined as a blow or jolt to the head, or a penetrating head injury that disrupts the functioning of the brain.  We know that over 80 percent of all TBIs are mild in severity.  In this presentation I'll be using the term mild TBI and concussion interchangeably.  

Then the question becomes what do we mean by mild.  Well, these are the criteria typically used.  Loss of consciousness less than 30 minutes, post-traumatic amnesia or alternation of consciousness for less than a day.  

We know that most individuals recover completely within days or weeks after a mild TBI both in terms of cognitive performance and in terms of symptom severity, yet there are a subgroup that may report PCS symptoms in the more chronic stages.  I'm going to use the term post-concussive symptoms rather than post-concussive syndrome today, and incidentally the PCS syndrome was dropped from the DSM-5.  These PCS symptoms are nonspecific, meaning that in longitudinal studies PCS symptom reporting doesn't tend to differ between mild TBI and entered control groups during follow up.  We know the prevalence of PCS within VA clinical samples can be substantial.  Typically the symptoms are categorized as physical, cognitive, and emotional.  Sometimes dizziness or vestibular symptoms are considered a separate factor.  

Here you can see from these numbers from the Department of Defense that most cases of TBI in the military are mild, and that there has been an increase over time likely due to the wars and to the implementation of system-wide screening and evaluation, both within DOD and VA.  We have a large number of current and future patients who are symptomatic following concussions.  

A variety of intervention approaches exist or have been described to address these symptoms, so there are what we might categorize them as symptom-based methods.  For example, treating the headache if that's somebody's complaint.  Some might be categorized as behavioral and include things like sleep hygiene interventions, cognitive behavioral therapy, et cetera.  Then we have educational or psychoeducational approaches, which have been most studied.  

Educational interventions typically include things like defining the injury and what to expect, normalizing symptoms, reassuring positive expectation of recovery, providing specific coping strategies.  An example for those who are interested is in a manual provided by Wiley Mittenberg and colleagues, which is available as an appendix in one of his published studies that I have listed there.  

What I'm going to do is share with you a very quick review of this literature.  I've summarized the entire non-medication PCS focused intervention literature, and I've put it into a series of tables.  I apologize.  The tables are a bit busy, but I wanted to give you a visual sense or a visual depiction of the existing literature.  The frame of reference here will be the psychoeducational approach that I just described.  

This slide shows the studies published to date that show a positive treatment effect with the psychoeducational approach just described.  There are six studies total, as you can see, and one thing to note is that they've all been conducted with individuals soon after injury, or roughly within a week of injury, so that's what I'm highlighting there.  Okay?  

Then this slide shows the studies published to date that failed to show a treatment effect with a psychoeducational approach.  There are three of these, as you can see.  When you read these in detail, you'll see that they're not good tests, and the focus wasn't really on the psychoeducation approach, and in two out of the three studies, PCS specific analyses were not presented.  For example, in the Gronwall study, the focus was on attention training, and the primary outcome measure was something called a PASAT, which is an attention performance measure.  In the Hinkle study, both intervention groups had a positive impact on return to prior functioning, and the control group wasn't really a control group in that that group was provided encouragement to return to normal activities and so forth.  

This slide shows the studies published to date that showed a treatment effect using other than educational approaches.  There are eight such studies, and you can see a wide variety of approaches here, including cognitive behavioral therapy or CBT, relaxation, and even physical exercise.  One thing you'll note are the small sample sizes and the relatively long time since injury for the participants.  Okay.  I have to go through my animation here.  

Then, for the sake of completeness, this is a slide showing you other than educational approaches with no treatment effect.  You can't really compare these to the prior slide because of the different approaches used here, including in particular multidisciplinary approaches, which are typically used with more severely injured patients.  You also see mindfulness training here.  You'll note the heterogeneity with respect to time since injury, also.  

To sum it up for you, this review shows that the four psychoeducational studies with prospective randomized control trials conducted approximately within one week of injury all demonstrate a reduction of PCS at follow up relative to controls.  It seems like the psychoeducational approach, there's good evidence that it works in the acute phase, or within a week of injury, roughly.  It's hard to draw many other conclusions from this review due to the different treatment approaches, differences between participants, et cetera.  It also seems that other approaches, in particular CBT in the post-acute and the chronic phases have demonstrated some efficacy in reducing PCS.  What we don't know is whether the psychoeducational approach works in the post-acute to chronic phase, or well after injury.  Obviously this would be of interest to those working with VA patients.  

We thought that educational interventions, given their nature, were particularly amenable to web-based delivery, so we did a pilot here in Tampa in which we tested a desktop prototype of such a website in a small sample of VA and emergency room patients.  As you can see here, there was a significant decline in PCS symptom severity in both the VA chronic sample and an acute civilian sample.  However, you'll also note there's no control group here.  We got a small pot of money to add a control group and to move the content to the web, and I'm going to show—I'm going to quickly go over that study with you now that we're just actually wrapping up.  

This was a randomized control trial in which we examined changes in PCS from baseline to seven days post-intervention, and then again six months post-intervention.  The intervention was self-administered.  It was interactive, and  it was on the web.  It was adapted from the Mittenberg materials that I mentioned earlier with some additional post-combat relevant material added.  These are the collaborators and co-authors on this study.  The participants included people with a history of mild TBI, age 18 to 55.  We excluded people with more severe injury or significant comorbidities.  You can read this.  We also excluded people who didn't experience—didn't report experiencing any symptoms at the time of injury and/or weren't currently complaining of symptoms.  

We primarily recruited people online using listservs and that kind of thing, but we also recruited a subset, about 30 percent, in person, so that to the extent possible we could verify their diagnosis through medical record review and through a structured interview.  This is a timeline of the study.  We screened for eligibility, did a baseline assessment, randomized them to the intervention or waitlist control group, and then followed them up at two time points subsequently.  

Our primary outcome measure was the NSI, the neurobehavioral symptom inventory, which I'm sure most of you are familiar with, used pretty widely in the VA.  Twenty-two symptoms, each rated on a five-point severity scale.  Because we were interested in attributions, we also created an attribution scale by asking whether they believed each symptom on the NSI was due to concussion.  We, of course, included other measures, some of which were the self-efficacy for symptom management scale, which basically is the extent to which one feels confident in managing one's symptoms and difficulties.  We also included a quiz so that we could assess the extent to which our participants learned from the intervention.  We also had measures of psychological distress that you can see here.  

The intervention, again, was web-based.  I'm showing you a screen shot of part of it right here.  It was also interactive, such that they would be asked questions about the material they were reading.  If they got something incorrect, which this person did—this person got two wrong—they were provided with the correct answer, which is what you see here.  There were several sections to the website, and you can see here we—in order to advance to the next section, they had to do a certain amount.  The exception where they had some flexibility was managing your symptoms.  That section was symptom-specific, so they clicked on those things that were bothering them.  

We screened 659 people.  The analyses I'm going to show you are based on the 138 people who completed all the time points.  We have 70 people in the control, 68 people in the intervention group.  Most of the participants were age 26 to 45.  Most were male.  Fifty-five percent had less than a four-year college degree.  Thirty-eight percent had a four-year college degree.  A nice distribution with regard to time since injury, so about 40 percent were about one month post injury, and you can see the other groups there.  Eight-eight percent use the internet daily.  Half of our participants reported a history of two concussions, 22 percent reported one.  

This slide, 40 percent yes, basically that means that the person answered yes to any of a number of questions having to do with receiving disability payments due to brain injury, receiving service connection or being involved in litigation due to brain injury.  Okay.  To give you a quick view of some of the data here, those with more than one concussion tended to report more symptoms at baseline than those with one.  This is to give you a feel for some of the characteristics of the sample as well.  

On this slide, the blue bars represent our sample.  The orange bars represent a cut score that is typically used in non-clinical or normal groups, and the green bars represent a possible cut score that—cut scores that are used in clinical groups.  You can see here that our sample, the blue bars, are near the clinical cutoff on these measures.  In part, that's because of our eligibility criteria.  In other words, they had to be symptomatic to participate.  

In our primary analyses, the treatment and control group didn't differ on the measures at baseline, so in other words the randomization worked.  We did a complete case analysis, so we have three measurements over time.  I'm going to show you the results of the repeated measure analysis.  As you can see, there's a drop in symptom severity across time, regardless of group.  You can see this drop, if you recall the slide that showed our pilot data, it's similar drop.  However, with the addition of a control group this time, we can see that the intervention had no differential effect.  Likewise, no differential effect by group on attributions to concussion, and no differential effect by group on psychological distress.  

Then the question becomes what is related to symptom change?  Our target was changing symptoms, so we took a look at this.  We wanted to know what is related to *[inaudible 17:29]* from baseline to six months, and you can see here that those who tended to show the most recovery tended to have more symptoms at baseline, tended to have greater self-efficacy at baseline, greater baseline satisfaction with social support, greater perception that concussion adversely impacted their life, and fewer attributions to concussion over time.  In other words, people who had the most reduction on symptoms tended to change their attributions over time.  In conclusion, there was no impact of this intervention at follow up.  There's some suggestion that symptom reduction is related to things like social support, self-efficacy, changing attributions or expectancies.  

This slide shows you a sub-analysis we did, an exploratory analysis.  While the majority of those in the treatment group did not differentially change their attributions, as I told you, and also did not differentially change their expectations for recovery, we found that when we looked only at those people who did change their expectations for recovery as evidenced by the way they answered certain expectancy type questions, then there was a significant treatment effect.  In other words, it seems that attributions and expectancies are what seem to be the driver here in changing symptoms, but the intervention did not seem to impact those things.  

I wanted to show you one last study that was done by folks at the National Center for PTSD.  It hasn't been published yet, but they distributed an educational booklet to veterans who screened positive for TBI.  Yeah, so a similar type of informational handout.  It's obviously shorter than a website, but it's a similar content.  Half received the booklet, half did not.  Here you can see that they found that knowledge of mild TBI increased for those who received a booklet versus those who didn't, so it had an impact on knowledge.  However, similar to our findings, expectancies weren't really affected.  How they answered questions like how long do you think your symptoms will last, that was not impacted by this information that they were given, but it did affect their understanding of their symptoms.  

It seems that, while the educational approach works in the acute phase, at least in the civilian literature, in our patients it was ineffective in changing symptoms in the more chronic phase, possibly because attributions and expectancies of recovery did not change.  

One last thing that I wanted to note is that there's currently a trial going on in San Antonio that I thought folks should know about if they don't already.  It's called SCORE.  It's being conducted—I believe the PIs are Dr. Amy Bowles and Dr. Doug Cooper.  That should help clarify how best to treat PCS in post-combat individuals.  They're randomizing folks to one of four treatment arms with varying levels of intensity and various interventions.  I'm told that those results should be coming out sometime possibly next fall, so you might want to keep an eye out for that as well.  

*Moderator:*Thank you very much, Heather, and we'll turn it over to Dr. Jak now.  

*Speaker:*Great.  Thank you.  I'm going to build on what Heather had to say, particularly in the area of computer-based cognitive training programs.  If you are ever on a computer or listen to the radio, you've probably heard advertisements for—Lumosity seems to be the big one right now that's advertising a lot, or your patients may have come in and talked to you about some of these commercially available programs, and so there really has been a huge increase in availability and popularity of these computer-based cognitive training or enhancement programs.  This review is going to go over the empirical literature to date on these commercially available training programs, hopefully to provide you—what I was looking for is, when patients come in and say, "Should I do this?  Does it really work?" you'll have some data to support what you're telling folks.  

Initially, a lot of these programs have been marketed to healthy adults looking more to enhance their cognitive skills or stave off negative outcomes, cognitive aging outcomes, but so this presentation is really going to focus on those aspects of it.  It's also been widely marketed more to parents, parents with children, and ways to enhance academic performance or remediate some ADHD sorts of symptoms.  I'm not actually going to cover the whole literature in children since we're in the VA.  I'm going to focus on the adult literature at this point.  It becomes a little too broad to do all of it in one short presentation.  

I'll admit up front that, honestly, there's much less information about how these programs have been used or the efficacy in folks with a history of TBI, but I'll try to take some of what we do know in different clinical populations and demonstrate its applicability to folks that have a history of mild TBI in particular.  I also want to say up front that I have no financial or commercial or really any other particular interest in any of the specific programs that I might mention, and so I'm not intending to endorse any specific program, but just trying to present this data, the empirical research in this area.  

All right, so just a brief background.  If you think about a more traditional cog rehab program or traditional cognitive rehabilitation, its goal tends to be more restoration of cognitive skills, improvement of general daily functioning.  A primary approach might be teaching compensatory skills like mnemonics or calendar use, other memory aids, usually delivered in person by some sort of clinical professional for a defined number of sessions.  There's any number of studies showing some empirical support for this traditional approach.  Cicerone has a nice review of the efficacy, particularly in TBI and some efficacy in stroke.  

Then the more analog, the old-fashioned things people looked into as far as ways to enhance cognitive functioning, not necessarily from a traditional cognitive rehabilitation standpoint, but things—because people want to know, what can I do on my own?  What could I do independently to try to improve my cognitive functioning or reduce my risk for cognitive decline as I get older?  There's been varying support for all of the things on this list over time.  It's very difficult with these sorts of activities to do prospective intervention studies because of difficulties in standardizing how much time one does these things, accounting for how much time one may have spent doing these activities prior to being in some sort of trial, so studying it prospectively has been a little bit challenging, and most of our information comes from epidemiological data, so it's looking back and asking people how much time did you spend doing these activities.  The exception to that, there was a kind of interesting albeit non-replicated study about teaching people to juggle, and subsequent changes in their cognitive functioning after the juggling program.  

For whatever reason, crossword puzzles received probably their—a substantial amount of press touting their cognitive benefits, and there is some support for this puzzle problem solving sort of activity to stave off cognitive decline over time, but the support isn't necessarily any better for crossword puzzles than it might be for some of these other activities that people lump into the cognitively stimulating activity department.  

Then if you move forward from these analog or more traditional thoughts about cognitive enhancement, you enter into the realm of computer-based training.  The motivation often is very similar to why people might have wanted to do crossword puzzles, or still might want to do crossword puzzles, but now it's more computer-based training.  Again, people want to be able to try to take some control over their cognitive functioning over time, to be able to do it independently.  Again, marketed often more towards ostensibly healthy adults for more cognitive enhancement purposes as opposed to strict clinical populations, but already within just the last few years computer-based cognitive training and enhancement programs is a multimillion dollar industry.  

It's been targeted mostly towards non-clinical populations, but increasingly researchers and clinicians were very interested in the applicability to different clinical populations.  Because of this exponential growth in this area, I think a lot of us, myself included, are really interested in a very critical examination of the research and a scrutiny of the scientific literature to try and evaluate some of the claims of the programs themselves, or just to provide well-informed information to our patients or our friends who are asking us about these programs.  

Generally, the computer-based cognitive training programs have some things in common.  They tend to be very game-like.  It's something like you might find a target in an array of distractors, or you'll practice list learning or a memory trial.  You do it multiple times, so repeated trials, and then the speed or the complexity of the task increases as your performance changed.  The goal usually is to improve your performance and the task might get faster or more complex, but if you're struggling it will also take you back a step and slow it down or reduce the complexity.  

Across the literature—and so there's a wide variability, but across the literature, it looks like people are studying this using a range of about—practice about somewhere in the 3 to 5 days a week range, anywhere from 15 to 100 minutes a day for about 4 to 12 weeks.  This is the range of what we're looking at for the active treatment intervention when people are studying it.  

Here are some examples of some widely advertised and widely popular computer-based training programs that also, in fact, have some available peer-reviewed research studies examining them.  This is certainly not an exhaustive list of all the computer-based training programs available.  My focus, and what this list generally includes, are programs that were designed with cognitive enhancement or training in mind.  

In that light, it doesn't include video games that were designed initially, at least, or ostensibly for just fun, for entertainment value.  Some of them have, in fact, some of those video games have then been studied as having possible cognitive benefits.  Games like Tetris, if you're familiar with that game where different geometric shapes sort of fall from the sky and you have to fit them into a puzzle, that was developed truly as a game, but it ultimately has been studied.  There's a whole literature studying some of these entertainment-based video games to see if they have any cognitive benefits.  I'm not going to go over that, and that's why those kinds of things aren't listed on my list here either.  

It also doesn't include any programs that might be computer administered, but were really meant to be still delivered in the clinic with supervision.  The focus here is really what have been designed to be in-home, independently done, that anybody could access.  If anyone, though, is familiar with Cogmed, that one straddles the line a little bit.  You do the cognitive training, the computer-based training independently at home or at work or at school, but you are followed by a professional that's looking in on your progress on the training that you do, so there is maybe a little bit more personal support with Cogmed, although the training itself is done at home, so it straddles that line a little bit.  

Then I am curious for—just to find out if you are using computer-based cognitive training programs with your patients.  

*Moderator:*Thank you, Amy.  It looks like the responses are streaming in, so we'll give everybody a little more time to get those.  Okay.  It looks like we have about a 50 percent response rate, but the answers are still streaming in.  Okay.  It looks like roughly one third of our audience does use computer cognitive enhancement programs, and about two thirds do not.  Thank you to our audience for those responses.

*Speaker:*Yes, thank you.  I'm fascinated, and maybe not entirely surprised that the majority right now isn't using these programs because they are newer and the data is just emerging about success with that, so thank you for your responses.  

Okay.  What generally does the literature tell us at this point about computer-based cognitive training or enhancement?  Optimally, what we're looking for is we like to see that these programs will elicit some effects that generalize from the task that you're doing on the computer to something more real-world or to a practical task—often that's evaluated by neuropsychological testing—and that then any of the gains that might have been made while doing the training would be maintained over time, even if folks stop doing the computer-based training.  

Globally, the empirical literature is very robust and strong that when you do whatever the computer-based cognitive program is, you get better at the task that you were doing, so you get better at the trained task.  Most of the programs also do have some data to suggest that this transfers, that you have a transfer of these benefits to untrained tasks, so that if you're working on a working memory module or an attention module on the computer, that you do show some benefits to those cognitive domains, often, as I mentioned, on neuropsychological testing or in some real-world environment.  However, there's also evidence sort of countering that of no transfer effects.  It's less robust at this point, that transfer effect from the task you're doing on the computer to something outside of the computer-based task, so it's there but not maybe as robust as improvement on the trained task itself.  

I will say the evidence is also very supportive of subjective responses being very favorable for the computer-based cognitive training programs, so there is—when people are polled and asked do you think that this helps you?  Did this improve your daily functioning?  Did it improve your memory?  Did it improve whatever you were trying to train with the computer-based program?  The evidence is quite supportive that people are saying, yes, I liked it.  It seemed to do good things for my cognitive functioning.  It seemed to do good things for my functioning in my daily life.  That part is quite positive as well.  

When there are transfer effects, or the most common and seems to be replicated piece of transfer from the computer-based program itself to something, either neuropsych test or something in the real world, is for processing speed.  That has the most robust findings with the computer-based training.  There's more emerging evidence now about that extended follow up, so that if you did the program and you did it for however long you were supposed to do the program and then you stopped, would you maintain those benefits over time.  There's emerging evidence that that is, in fact, the case, and particularly with processing speed.  

At this point I would say that, by my read, it looks like Cogmed and Brain HQ have the most evidence of maintenance of gain anywhere from months to years later.  Part of that may also be because they seem to have the most empirical literature investigating their program compared to the other programs, and also Cogmed has been around a little bit longer, so there's more opportunity to have that longitudinal follow up and look at that follow up data.  For some of the other programs, it may be that it's simply the data doesn't yet exit or there's not the longitudinal follow up yet being done to confirm or not confirm the benefits over time.  

As I mentioned, many of these programs have been marketed to and then subsequently studied in adults, particularly healthy older adults, but also often in adults with mild cognitive impairment.  Other clinical populations that have been studied with these computer-based training programs include HIV individuals, post-chemotherapy, that describe the experience of chemo brain, in neurologic and psychiatric populations, in particular in schizophrenia.  They have been used in traumatic brain injury, but often they've been reported in more moderate to severe TBI cases, and right now there is a limited amount of data on the efficacy of their use in a mild TBI population.  

However, if you do take a look at any of the websites for any of the cognitive training programs, there usually will have a research section that will list their peer-reviewed studies and also their non-peer-reviewed studies, but any research that maybe has applied their computer program, as well as often they'll list works in progress, so studies that are underway.  If you look at that, there does appear to be a lot of work with mild TBI in the pipeline, but we don't have the data yet.  

What I would say, though, is that a lot of the populations that have been studied, so HIV, some of the psychiatric population, post-chemotherapy, tend to have similar concerns in domains like attention, memory, and processing speed that are also commonly impacted following a mild TBI, so there definitely may be some benefit to using these programs in mild TBI, given how they've been used in existing clinical populations.  

The other question in addition to does it work, it's all great if it works but what if people can't actually use this?  The idea is that we might be sending patients home where they're going to go try this, but they're going to have to do it independently.  Is it reasonable that a potentially cognitively, even mildly cognitively impaired population, would be able to navigate the computer system, would be able to stay on track and actually maintain some level of compliance with these programs?  Again, the data is very limited, but it's positive.  

In a very small study of about 10 people that looked at feasibility of using—in this case it looked at an earlier version of the Brain HQ program—70 percent of folks reported that they had little to no difficulty using the program.  In a separate study that was looking at older adults that self described as not being particularly used to using a computer, not necessarily tech savvy, this group of older adults still reported that they were very able to use the computer-based training and reported that it was a very positive experience.  In fact, some of them reported that it actually helped them feel more connected to some of their particularly younger family members that were more computer savvy, that they felt like having their new computer-based and maybe cognitive skills sort of helped them connect with their family.  

Compliance rates are not always reported, but the range when they are reported seems to be 60 to 80 percent maintain an average rate of compliance, which is not bad, especially if you're familiar with compliance rates with other in-person therapies.  

Then what about side effects?  In general, we don't anticipate a ton of negative side effects from computer-based training, but the most common one reported, albeit this was in that small study of ten individuals, was fatigue.  Some headaches, some eye strain.  All of those side effects also dissipated over time.  This was the percentage of people reporting them from the beginning, and as they followed over time individuals would indicate that these symptoms reduced and reduced over time.  

In addition to then the empirical support that's emerging for the efficacy of some of these programs, computer-based training may have other benefits for clinical populations, including expanding accessibility if it's difficult for folks to travel or because they're otherwise have a very busy schedule with work and school and rearing children and whatever the case may be, to provide some flexibility about when they could do some of their cognitive training.  It requires fewer resources as far as you don't need to have somebody come and have a room to see them in, to have the personnel to see them in, so it may require some resources that many people do have at this point.  

There's been some anecdotal feedback about the fun factor of these games, and I'll admit that I registered for some free trials of a bunch of them just to get myself familiar with how they really function as well as the data, and they're very engaging.  I'll cop to the fun factor as well.  They're very engaging and they hold your attention.  They feel very space valid.  As I mentioned, they also appear to have minimal side effects besides maybe some fatigue, headache, and eye strain, which do appear to, at least in a preliminary look, seem to dissipate over time.  

There has also been very little research so far, then, seeing—especially maybe slightly higher functioning populations—whether traditional cognitive rehabilitation, how does that compare to some of these independent computer-based cognitive training modules.  Right now, this is from one meta-analysis, and it looks like there's some comparability between some traditional approaches versus more modern computer-based cognitive training.  Again, this is from a meta-analysis, and it may ultimately not be a 100 percent fair comparison because often we're targeting a slightly different population with traditional cognitive rehabilitation.  We're maybe even looking for different outcomes in traditional cognitive rehabilitation versus the computer-based cognitive enhancement programs, but it's nice at least to take a look at some of the initial data to suggest that there are some benefits and they hold some comparability, at least in some domains, to what we might be trying to do in-office with patients.  

Okay.  That leads us to the limitations of the current research, and there are many.  The control group is not often an active control group.  That's gotten better with newer studies, but often it was just sort of a wait list control group.  Initial studies were also very limited in being independent from the developers of the computer-based training programs or peer-reviewed research, although that is improving over time as well.  I've already mentioned long-term follow up, that that data is emerging, and that's really something, I think, that we all would like to see to feel more confident about the efficacy of these programs.  Looking more at ecologically valid outcome measures, so again, that transfer to the real world.  Does this really help people at school or at work?  

Like with some of the data that Heather presented, this literature is also plagued by very small sample sizes, so looking at it in larger samples is important.  There's also a very large amount of variability in how much time people spend on these training programs, so it does make it a little difficult to compare one program to another because of that variability.  A lot of the initial work has been done in higher functioning populations or in normal adults, and so they are starting in the normal range to begin with, which makes then evaluating change over time a little bit more difficult.  As I mentioned, the programs haven't been as widely used in clinical populations as they have maybe in slightly more cognitively normal populations.  

For me, I would think that the take-home message that I have from the review of the literature is that processing speed is one of the domains that seems most robustly impacted by computer-based cognitive training, and so the programs may really hold promise for improving functioning in this cognitive domain, particularly in TBI.  This is an area of cognitive functioning that's often impaired in folks that have a history of mild TBI, and so it may be particularly useful, especially since that's one of the more robust findings throughout the literature.  

It may also be that computer-based training serves as a good adjunct to some traditional cognitive rehabilitation.  One of the comments that did come up in that small feasibility study that I showed you was that somebody commented that they wished they had more strategies to help them improve their performance on the computer-based activities.  They were sort of into doing the practice, but they didn't necessarily have any tools to help them really improve besides just from repetition, and so that's where a marrying, maybe, of some traditional compensatory cognitive rehabilitation approaches could map on with an adding some of the computer-based training programs as a way to practice skills that you might have learned in clinics.  

At this point there is emerging and positive evidence supporting the use of these programs, but the technology and the development of these programs may actually have outpaced our scientific investigation, so in many cases the data isn't negative.  It's just not there.  It hasn't been replicated to gauge the true efficacy of these commercially available computer training programs.  The preliminary data is generally positive, particularly, as I mentioned, with processing speed, and the programs do appear to be user friendly.  They're well tolerated and seem well liked, and so may hold particular benefits for increasing accessibility to cognitive training and possibly as an adjunct to traditional cog rehab, particularly in clinical populations.  I'll end there.  

*Moderator:*Great.  Thank you very much to both of you.  We do have time for questions with the audience, so for our audience members, please submit your questions and comments using the Q & A box located in the upper right-hand corner of your screen, and we'll get to those in the order that they're received.  The first question we have is for Dr. Jak.  What types of control groups are used in cognitive training studies?  In other words, how do they control for interacting with computer and time spent on computer?

*Speaker:*It's varied.  Some of them will do—some things that have been used are things like reading on the computer, so kind of giving novel information that you'll spend time just reading new data.  Some of it is they'll do a no activity control.  Some of them will compare graded programs.  Most of the programs now, they get harder and harder and challenge you more as you get better at them, and so sometimes the control group has been something like just keep doing the same level of difficulty over time, and not have it a graded improvement over time.  Those would be some examples.  

*Moderator:*Thank you for that reply.  The next question, best method for ordering monthly renewal and tracking new Brain HQ version.

*Speaker:*I don't know that I have any answer for that question, actually.  *[Laughter]*

*Speaker:*I don't, either.

*Speaker:*As I said, I'm not particularly a advocate of any one of these programs, and so that might be a better question directed to the folks at that particular program.  

*Moderator:*Thank you.  The next question we have, do you have any insight on patients with visual problems as well as cognitive?

*Speaker:*For the computer-based training, I'm guessing?  There's not any—well, there is some data, so there's a few programs that have some modules that are geared towards visual-spatial training and have some outcomes in looking at older adults about driving, so there may be some limited and sort of emerging evidence of those sorts of things, probably, I guess, if that was the target was the visual-spatial processing.  I don't necessarily have any other information about how the programs in general might be received or tolerated or found to be useful to folks that might have some visual impairment, but that's a really good question. 

*Moderator:*Thank you.  The next question, do you accept consults?  If so, what is your consult criteria?

*Speaker:*Not sure that I 100 percent—consult to use the computer-based cognitive training?  I'm kind of guessing that's the question.  

*Moderator:*I'm not sure.  We can wait for them to write in and clarify.  In the meantime, we'll move on to the next question.  Is there any comparison of computer-based training improvements and studies such as SMRI?

*Speaker:*I think I found one study that did show some—yes, some sort of improved or differential activation following computer-based cognitive training in a positive direction.  I didn't spend much time on that because it was one singular and small study, but I think that data is coming and this may have just been the first study to come out.  

*Moderator:*Thank you for that reply.  The next question, in your opinion, does the available research on computer-based cog rehab support the current claims being made when these products are advertised to consumers?

*Speaker:*I think it depends on the claims.  There are some that seem to be more general, and I think the data supports that.  To some degree, I would say that the data does support the claims made by the programs themselves, but I think it also helps to really read what those claims are because I do think that they have the data to back it up saying that it might improve processing speed, that you're going to get better, that you're going to improve on the task that you're doing in their program.  Those claims, I think, would be accurate.  Any more vast claims about generalized ability are potentially more tentative, and I would be a little bit more suspect of those, but, as I mentioned sometimes it's simply that the data just isn't available yet.

*Moderator:*Great.  Thank you.  The next question, as licensed rehabilitation professionals, is it important that we identify a credible mechanism responsible for the effects that are being reported for computer-based rehab, or is the identification of a mechanism purely academic?

*Speaker:*That's a really great question.  In the world of rehabilitation, I think we want both things.  *[Laughter]*  Sometimes we just, we want to see functional change in our patients.  Right?  We want to do things that ostensibly are helping them do better in their daily lives.  That's the end goal for rehabilitation, and so I think there's maybe a part of it where it is just, okay, the mechanism maybe does become academic.  If it's working for this particular patient and it's improving their functionality, that's what we're going for.  

On the flip side, I agree that I think understanding some of the neural underpinnings of how this is working is important and probably will help us to better develop new strategies and new programs, and really hone in on what piece of the training is actually working.  With the SMRI single study that I mentioned is, I think, trying to look at some of those actual neural underpinnings.  There was also one very small study looking at dopamine receptors following some of the cognitive based training, so I do think that we are trying to better understand what the neural underpinnings are, but that literature is pretty small at this point as well.

*Speaker:*I would add that maybe part of that question was if we change people's perceptions—one of the things you mentioned, Amy, was the literature suggesting that there is a change in perception of people who use these programs.

*Speaker:*Mm-hmm.

*Speaker:*Maybe that was part of the question, too, was if we change people's perceptions, that might be important, but of course we would want to be changing their functioning, too.

*Speaker:*Yeah.

*Moderator:*Thank you both for those replies.  We do have about five pending questions.  This one is follow up from the consult question.  Would this be done at San Diego VA by consult to psychology, or through Two East Cognitive Clinic?

*Speaker:*On a very practical level, I would have been the respondent that said no, I'm not using these programs with my patients yet.  Right now, we don't offer them clinically through the VA.  It's been more so far people coming in—patients saying, well, I got a trial of whatever on the computer.  Is this really going to work?  Is this really going to help me, as opposed to doing it in-house in the VA at this point, but I'm only speaking for our setup here in San Diego.

*Moderator:*Thank you.  This next one is for Heather.  Can we expect different results of psychoeducational intervention on—and then it's kind of cut off.  *[Laughter]*

*Speaker:**[Laughter]*  Okay.  I'm not sure what the question is.  Can we expect different results?  I mean I can try to take—

*Moderator:*Oh, here we go.  Sorry.  I found the second part.  Okay.  Can we expect different results of psychoeducational intervention depending on delivery mode, for example, computer versus in person?

*Speaker:*Yes.  Well, that's a great question, and that's something that we didn't answer with this study, so that you're cutting to the heart of the matter, which is the literature that I reviewed showing a positive effect in acute samples, those were done in person.  Had we done the perfect study here, it would have included an in-person arm as well.  We didn't have money to do that, but so that's still an open question.  Is there something about personal interaction that may better change attributions and expectances?  Well, we don't know that, so I don't know the answer.

*Moderator:*Thank you for the reply.  Can you comment on Blue Marble?

*Speaker:*I assume that's yours, Amy.

*Speaker:*I have to say I can't comment.  Can you comment, Heather?  I'm sorry.  I'm not familiar with that one.

*Speaker:*No, me neither.

*Moderator:*Okay.  Not a problem.  This next one is a little long.  I've used computer-based training programs for various kinds of brain injury, and it isn't clear whether there were real treatment effects or whether I was riding the wave of recovery, particularly true for post-acute treatment.  My experience was that difficulty with retention of new learning interfered with maintenance of effects over time.  It seems that the profile of neuropsychological deficits would affect how well a given patient benefited from using computer programs.  What range of individual variations have you observed across types of brain injury?

*Speaker:*Yeah, I think that's a very insightful comment, that it goes maybe a little bit back to the feasibility, that you are going to have to have a certain level of cognitive skill to implement some of these independently.  We do see a very wide range across TBI, mild to severe, and level of cognitive deficit, and so somebody that potentially has a higher level of executive dysfunction may in fact struggle more, then, with implementing some of these programs independently, versus folks maybe on the more mild end of the TBI spectrum that do have generally maybe more intact executive functioning and just mild problems with processing speed or variable attention may end up doing better.  Because you're right.  There is quite the range of deficit across TBI as a whole.  

*Moderator:*Thank you for that reply.  We have reached the top of the hour, but we have about four pending questions.  Are you ladies available to stay on and answer those?

*Speaker:*I am.

*Speaker:*Sure.

*Moderator:*Excellent.  Thank you.  Can it be the case that the computer savvy population also has more access to psychoeducational materials than those who are not, and that may have affected the negative results?

*Speaker:*Absolutely.  Yes.  It's difficult to have a control group in this type of study.  Amy was talking about control groups with regard to the cognitive training studies.  We had a waitlist control group, which is not ideal because you're not controlling for interactions on the computer.  We also can't control what any of the participants are doing in that six-month interim, and maybe just being in this study that's drawing attention to concussion made them seek out information.  That's a great point.

*Moderator:*Thank you for that reply.  Let's see.  We have several people that wrote in thanking you for the great presentation.  This person writes much of the marketing materials appear to make claims about improving, quote, "memory," and, indeed, this is the presenting concern for many of our patients.  Granted, there might be empirical support for improvements in working memory.  This seems not to be what the patients really are looking for.  Is there any empirical support for improvements in memory encoding, storage, or retrieval?

*Speaker:*The empirical support, when it is there for memory, seems to be more on the encoding end.  The programs aren't targeting storage and aren't targeting retrieval.  It's really targeting encoding, either via some sort of practice at that or with improving attention as a precursor to what you'd need to encode new information.  There were some studies that I reviewed that showed memory improvement.  They're there.  They're not as frequently—it's just that that's not always replicated, that transfer.  Right?  You might get better at their memory task or whatever is in the computer-based training, but then the transfer to the real world for memory is—there's been less replication of that.  I would be sort of cautiously optimistic about that, awaiting better sample size, better replication, better transfer to the untrained task.

*Moderator:*Great.  Thank you for that reply.  Let's see.  The next question, how does, quote, "processing speed" translate into everyday life?  Is this variable different for individuals with MTBI alone compared to those with TBI and PTSD?

*Speaker:*Well, processing speed is often something that we see in psychiatric presentations as well, so depression or PTSD or you'll often see some decrement in processing speed.  In that sense, it's kind of nonspecific, as Heather was describing for some of the symptoms—in post-concussive symptoms.  It's not necessarily different between somebody with a history of mild TBI and somebody that has PTSD, as an example.  

In the real world, what people typically describe as feeling like they're doing better with processing speed is that they just feel sort of quicker to figure things out, that they're quicker to carry out cognitive tasks, and that's often what we're measuring on neuropsychological tests is that speed.  That's maybe one of the reasons why it's more robustly seen in the computer-based programs because that's often one of the things that's being trained is the rapid response, but the interesting thing, then, is that it does seem to maintain over time.  It's sort of like building up a muscle and then it seems to stick around, that you seem to continue to process faster, even if you're not doing the program anymore.  

*Moderator:*Great.  Thank you for that reply.  I'm going to ask our attendees to hold on for just one second.  I'm about to put up the feedback form, and we love to get your feedback as it is your requests for future sessions that we take a look at.  I just want to thank our presenters for joining us today.  We appreciate you lending your expertise to the field.  I also want to thank all of our attendees for joining us today.  As I mentioned, I am about to put up the feedback form, so hang tight for just a second.  Thank you, Amy.  Thank you, Heather, and thank you, Ralph, for organizing this.

*[End of Audio]*

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