Hello and welcome to the AAPMNR Conference 2020. I'm Dr. Avinash Ramchandani, a physiatrist and pain management physician at Redwood Pain Institute in Santa Rosa, California. Today is Diwali. Just wanted to wish everybody Happy Diwali for everybody that's celebrating the Festival of Lights. And I'm going to be introducing the people that are presenting research. So neurological rehabilitation is the topic. It's a pleasure to introduce these fine researchers to you today. First, I will introduce Dr. Alyssa Taubman. She's a resident physician at Spalding Rehabilitation Hospital. Her career goal is to improve care for individuals with traumatic brain injury, both through improvements in clinical practice and community resources. She's going to be talking about changes in the severely disabled rehabilitation patient population following traumatic brain injury. Thank you. And here's Dr. Taubman. I'm Alyssa Taubman. I'm a PGY3 in the Spalding-Harvard PMNR Residency Program. And today I'll be talking about our work examining changes in the severely injured TBI patient population. Recent work has shown that the population of TBI patients admitted to inpatient rehabilitation facilities is changing in several important ways. There's been an increase in the number of TBI patients admitted to inpatient rehabilitation facilities. And this population is increasing in age and has decreasing lengths of stay. Change in injury mechanism may be one factor accounting for some of these changes. With falls surpassing motor vehicle accidents as a major cause of head trauma in the U.S. in 2008 and now accounting for a growing proportion of head injuries in the U.S. and in Europe. Patients with disorders of consciousness, or DOC, are an important cohort for research and, more importantly, are at risk for worse outcomes if they don't have access to appropriate specialized rehabilitation care. Trends for this specific population have not been examined and may be impacted by changes in injury mechanism as well as changes in insurance practices. The Uniform Data System for Medical Rehabilitation, or UDSMR, is a database that contains patient outcome data for over 70% of IRFs in the United States. This includes data from over 200,000 TBI patients discharged between 2002 and 2016. The goal of this study was to examine trends in the most severely injured cohort of TBI patients using the UDSMR. Though this database does not have injury-specific data, it does have functional data in the form of the FIM, or Functional Independence Measure, which measures a patient's level of impairment and ranges from 18 to 126. We used FIM as a proxy to identify the most severely injured traumatic brain injury patients. We developed an approximate FIM using the Spaulding-Harvard TBI Model Systems database, specifically looking at the FIM for patients with DOC. For these patients, admission FIM ranged from 18 to 21, with an average of 18.3, with the vast majority of these patients having an admission FIM of 18. As a result, a FIM of 18 was chosen to approximate the most severely injured cohort of TBI patients. We next obtained data from the UDSMR, including patients with a diagnosis of traumatic brain dysfunction and an admission FIM of 18, who were discharged between 2002 and 2017. We analyzed trends in demographic, medical, and outcomes data. 10,098 patients were included in our study. From 2002 to 2017, the number of severely injured TBI patients discharged from IRS per year decreased from 649 to 488. More strikingly, the proportion of TBI patients with severe injury decreased by approximately 50% during this time period. This is shown in the graph on the left, which shows the percent of severely injured TBI patients as a proportion of total TBI patients over time. Also shown in this graph is the length of stay for severely injured TBI patients, which decreased by 12.2 days over the time period. This was more than twice the decrease observed in the total TBI population. During that time, the mean discharge FIM decreased from 47.2 to 43.4. And other notable trends include an increase in age, which is shown in the graph on the right. This increase in age is similar to that observed in the entire TBI population. In terms of primary payer source, there's an approximately two-fold increase in the proportion of Medicare patients and a concomitant decrease in the proportion of commercially insured patients. We can draw several important conclusions from this study. Of the over 200,000 TBI patients discharged from IRS between 2002 and 2016, only 9,600 had an admission FIM of 18. Despite an increasing number of TBI admissions to IRS, the number of severely injured TBI patients decreased over this time period. This decrease may be due to a number of factors. It could be due to changes in injury mechanism, which are leading to a decrease in the incidence of severe TBI. It could be due to increases in early ICU mortality or due to alternative discharge dispositions due to changing insurance practices that don't appreciate the long-term potential outcomes of these individuals. Other studies have shown that as many as four and five individuals with moderate to severe TBI are discharged directly home from acute hospitals rather than to IRS, and it's become increasingly difficult for these individuals to attain access to care, whether in IRS or in the community. Other notable trends include an increase in age in severely injured TBI patients, and further, the length of stay for these individuals is decreasing dramatically and at a much faster rate than the decrease occurring in the total TBI population. They're being discharged at a higher level of disability. This is concerning because it represents a decrease in access to specialized rehabilitation care for our most severely injured TBI patients, including patients with DOC. These are patients we know are at risk for worse outcomes when they don't have access to appropriate rehabilitation care. Additionally, this may cause difficulty maintaining enrollment in clinical trials involving patients with DOC and also inadequate access to this patient population for brain injury trainees. Overall, further investigation is required to understand the decrease in severely injured TBI patients being admitted to IRS, as well as the implications of these results on long-term patient outcomes. Hi, everybody, again. If you have any questions, you can leave it at the Q&A section on the left, and we will answer your questions at the end of the session where everybody is available live. These are pre-recorded sessions. So next, I'd like to introduce Dr. François Bethal. He is a physiatrist that currently serves as a chair of the Department of Physical Medicine Rehab in the Cleveland Clinic Neurological Institute. He's also the Director of Rehabilitation Services at the Mellon Center for MS Treatment Research and Medical Director of the Arts and Medicine Institute at the Cleveland Clinic. Without further ado, here's his presentation. Hello, my name is François Bethal. I'm the chair of the Department of Physical Medicine and Rehabilitation at the Cleveland Clinic. I'm pleased to present my poster on the effect of nabiximals, cannabinoid, or omicosal spray on spasticity and muscle strength in persons with multiple sclerosis across three randomized control trials. That's definitely a mouthful of a title. Before I start the presentation, I want to report two disclosures. One is that Greenwich Biosciences has sponsored this analysis and the resulting presentation, even though the educational event itself at the meeting is not sponsored by the company. And Greenwich Biosciences manufactures nabiximals, which is not indicated for any medical use in the United States right now. I am a paid consultant for Greenwich Biosciences. So the purpose of this analysis was to answer a question that is often asked in the management of spasticity, be it in MS or other disorders. Actually, it seems that patients with MS are more susceptible to this problem, which is that treatment of spasticity can be associated with a decrease in muscle strength. And the decrease in muscle strength then can impair function further. So the idea was to try and see, through a pooled analysis of three randomized control trials, if there is an association between reduction in spasticity and a reduction in strength that would suggest that that's a potential side effect or adverse effect from the medication. So this table describes the methodology of the three clinical trials. Briefly, they had many similarities. They were all including patients with confirmed diagnosis of MS who had spasticity as a result of MS. And the spasticity was not optimally managed with what is considered the standard of care, which generally is a combination of stretching physical therapy, occupational therapy, and traditional oral medications. So this was a general requirement to be part of these trials. You notice that one of these trials was a straightforward placebo-controlled six-week randomized control trial. The other two trials had two phases. That means they had an enriched design. The first phase, or phase A, was a single blind phase during which patients' participants were getting the medication, the nabiximals. And then at the end, they had to satisfy a certain threshold for improvement in spasticity, as reported on the spasticity numeric rating scale, to enter the placebo-controlled phase, which was a typical randomized control trial, double blind, placebo-controlled. And for Savant, in addition, there was actually a washout period before entering the placebo-controlled phase, which was not present in the 604 trial. So some common features, some differences. You notice also that there is a common measure of spasticity across these clinical trials. That's the spasticity numeric rating scale, which is a self-report measure of spasticity. It has been validated in MS. But it does not involve an objective clinical examination. The measure of muscle strength was the motricity index, the lower extremity section of the motricity index. And then in some of these studies, two of these studies, there was a measure of comfortable walking speed, the timed 10-meter walk, which is very commonly used in gait clinical trials or rehabilitation clinical trials, where gait is an important outcome. So that was a self-selected speed over a 10-meter distance. Only the 106 trial did not use this measure. So again, that participates to the different differences in methodology between trials. I didn't mention the threshold for qualifying for the placebo-controlled phase in the two studies with entrenched design. And that was a 20% improvement in spasticity NRS score. And the understanding was that patients, participants, were receiving standard of care in addition to the nabiximals during the trials, during the phase A and the phase B. In addition, I'm going to move on to the next slide. So you can see here the results from the trials. So in all three studies, there was a significant change, a statistically significant difference in change between the placebo arm and the nabiximals arm for the NRS for spasticity. And you can see the treatment difference, the effect size, basically, that was reported here. So that was a constant finding through all three trials, suggesting that there was an effect, a treatment effect with the active medication, the nabiximals, compared to placebo in all of these trials. In the two trials that used a motricity index for change in muscle strength, basically in the lower extremities, in the lower extremities, you notice that there was no statistically significant difference in change between the placebo group and the active treatment group. And the same was true for the change in mean time 10 meter walks in the study 604 and Savant. So basically, the significant change was only for the change in spasticity, which already was a reassuring finding in these trials. But that by itself would not exclude a possible association between changes in spasticity and changes in muscle strength or walking speed. Therefore, we conducted a correlation analysis. And you can see here that using the Pearson correlation, if we look at the correlations between change in motricity index and the change in spasticity NRS, the correlation coefficients are all below 0.3 for the nabiximals and placebo group. This is also true, for the most part, for the change in time 10 meter walk versus change in spasticity NRS, except for the nabiximal arm of the Savant study, where the correlation coefficient was 0.326. However, based on the large confidence interval for this correlation coefficient, it was concluded that this association was also considered to be not meaningful. So overall, by using a correlation coefficient, we didn't find a meaningful correlation between change in spasticity on the numeric rating scale and change in strength with the motricity index or change in 10 meter walk. So if you look at the graphs, you can see that the cloud of points, if you wish, for the correlation between spasticity NRS and MI also shows that there was no clear association in patients whose spasticity was reduced. Some of them had an increase in MI, some of them had an increase in MI, some of them had a decrease in MI, some of them had no change in MI. And for the correlation between spasticity and 10 meter walk, you can see that there was a possibility, if you look at the Savant intent to treat population, there were some patients who had a decrease in motricity index when they had a decrease on their NRS for spasticity, but overall, the association was not considered to be meaningful. So in conclusion, based on this analysis, we didn't find a meaningful correlation between a decrease in spasticity on the NRS and decrease in strength or decrease in comfortable walking speed, which is reassuring with regard to the potential use of this medication in the management of spasticity in MS. Thank you for your attention. Thank you, everybody. A virtual round of applause. And the next person I'm going to introduce is Dr. Elliot Roth. He is the Paul B. Magnuson Professor and Chairman of Physical Medicine Rehabilitation at Northwestern University Feinberg School of Medicine. He's an attending physician on the Brain Innovation Center of the Shirley Ryan Ability Lab, which was formerly called the Rehabilitation Institute of Chicago. And the Chairman of the Department of Rehabilitation Medicine at Northwestern Memorial Hospital. He is going to be presenting on Noninvasive Spinal Stimulation Improves Gait in Long-Term Stroke Survivors. And without further ado, Dr. Roth. Hello. I am Elliot Roth, a physiatrist and investigator based at Northwestern University Feinberg School of Medicine and the Shirley Ryan Ability Lab in Chicago. And I'm pleased to report on our preliminary findings from a small group of participants who were involved in an exciting and innovative project using noninvasive surface spinal electrical stimulation to improve gait function in people with long-term impairments resulting from stroke. Most of us are aware that gait among people with stroke is characterized as being slow, asymmetrical, and energy consuming. And many therapies, of course, are used to address these deficits. Our group has been examining a novel approach involving the use of electrical spinal stimulation. And it's important to note that the stimulation is superficial, not invasive, and performed also in combination with gait training. As many of you know, it has been proposed that spinal cord microcircuitry is altered in people who have spinal cord injury. And it's thought that in these circuits and the associated reciprocal leg movements and gait problems that accompany these deficits might be restored by using spinal electrical stimulation to reactivate those circuits. So based on the suggestion of Dr. Reggie Egerton at UCLA, we thought that perhaps a similar spinal cord interneuronal dysfunction might also be taking place after stroke, not only spinal cord injury but also after stroke. And perhaps electrical stimulation together with associated gait training might also restore spinal circuitry and therefore the associated rhythmic leg movements in people who had stroke as well. And in fact, studies using transcutaneous magnetic stimulation-induced motor evoked potentials, including studies performed by us and by others, also confirm that spinal circuitry is, in fact, altered in people who've sustained a stroke. This is important and novel because past studies of stimulation in people with stroke have focused, of course, understandably pretty heavily on brain stimulation. And so it's important to understand that this technique is actually different. Other standout features about this program is that the stimulation is surface stimulation, not invasive, not epidural stimulation, and that also the stimulation is not done by itself but also in tandem with, together with, associated gait training. So this study was an attempt to trial this concept. This was a proof-of-concept study to demonstrate that this concept might actually be effective. So to do this, we recruited eight individuals with hemiparesis resulting from stroke at least six months earlier. Data from each of the four of the participants who actually received formal stimulation were matched by data from other stroke participants who were matched specifically for age within plus or minus three years, time since stroke also plus or minus three years, and also gait speed matched within 0.15 meters per second. And after providing informed consent, each participant then underwent a protocol of the associated electrical stimulation together with the gait training specifically for those four individuals who were in what we call the stim group. The protocol was three sessions a week for eight weeks, 45 minutes each session, first having the subjects lie on their side with their legs dangling on a device that consisted of pulleys that hung from the ceiling with boards that were suspended from the pulleys that were able to move reciprocally for about 15 minutes. All the individuals, those who were in the stim group and those who were not in the stim group, actually did that program. This was followed by treadmill gait training for 25 minutes and that was followed by overground gait training for another five minutes. During the gait training, the four participants who were assigned to the stim group then received surface stimulations with the electrodes applied to the skin of the spine. And very specifically, these were in specified locations at the C5-6 level, the T11-12 level, and also the L1-2 level. And these were stimulated using continuous biphasic waveforms using rectangular one millisecond pulses at a frequency of 30 megahertz, I'm sorry, 30 hertz. The match control group underwent the sideline and the gait training as I specified earlier, but they had no formal electrical stimulation. So our goal was to study gait symmetry and also gait speed. And accordingly, our outcome measures matched those objectives. So these outcome measures were based on temporal spatial parameters, especially based on measures of symmetry. We used a number of measures of symmetry and also based on gait speed, specifically using the 10-meter walk test and the six-minute walk test. These were measured at both baseline before the participation in the program and then post-intervention. And we compared the group data post-training to the pre-training data and compared them also to the minimal clinically important differences. We also looked at individual data, but what we'll report here is really about group data. As a group, probably the most significant dramatic finding was that the stim group demonstrated a 28% improvement in step length symmetry, and that is extremely important, while the symmetry measures for the control participants did not change at all. The 10-meter walk test and also the six-minute walk test, both measuring gait speed, improved in all of the subjects, but for the stim participants, improvements was substantially greater than for the controls and also was substantially greater than the minimal clinically important difference. There's many other measures, but really the ones that I just shared with you are really the most important ones. So we concluded that non-invasive electrical spinal stimulation during and combined with associated gait training is likely to improve gait symmetry and gait speed. We think that this likely occurs by reactivation of previously silent neuronal circuits in the spinal cord or else possibly by promoting neuroplasticity in the complex interneuronal circuitry system within the spinal cord. We are grateful to our collaborators and to our internal funding from the Shirley Ryan Ability Lab and the Frankel Foundation for supporting this work. Thank you. A virtual round of applause there for Dr. Roth. Next I'm going to introduce Kriya Mae Kong. She's a clinical research assistant at Santa Clara Valley Medical Center. Kriya obtained a bachelor's degree from San Jose State University in 2014, and she's a double major in biological forensic science and molecular cell biology. She also has a double minor in chemistry and Spanish, and she is the research coordinator for four spinal cord injury studies. And without further ado, she's going to be talking about increasing access to care using telemedicine in individuals with spinal cord injury. Thank you for your interest in SIPAD, increasing access to care using telemedicine in individuals with spinal cord injury. My name is Kriya Mae Kong. The PI of the study is Dr. Kazuko Shen, and our team works at Santa Clara Valley Medical Center in San Jose, California, where SIPAD was conducted in 2014. So what is SIPAD? It's telemedicine using iPads for spinal cord injury patients, hence S-C-I-P-A-D, or SIPAD. SIPAD remotely connected individuals with SCI to SCI specialists. We received a quality of life grant from the Craig H. Nielsen Foundation. Our goal was to test the feasibility of FaceTime application among individuals with SCI. So why SIPAD? First, why did we choose an iPad? It's because many applications on the iPad, such as FaceTime and iMessage, have end-to-end encryptions for added protection at no additional cost. We are all aware of the many barriers faced by the SCI population, such as cost. In the first year alone, SCI patients spend about $400,000 to $1.15 million, depending on their injury. Now, secondary complications are also common in the SCI population, with genitourinary and skin disease being the leading causes. And of course, with a pandemic, there is an additional barrier, which is temporary closures or pause of clinical services on top of geographic barriers to specialized care. Therefore, providing innovative, efficient, and private care is crucial for meeting the ongoing needs of SCI patients, which our objective is to improve patient engagement and access to care in individuals with SCI through telemedicine. Now, how does it work? SIPAD was successful because of its design. It was built to be easy and not time-consuming. Even at enrollment, consenting, completing surveys, providing training took about 30 minutes. At enrollment, participants received an iPad with a six-month data plan, blood pressure cuff, stylus, and adaptive accessories that were assessed by an occupational therapist. Now, if you focus your attention on the purple columns in figure one, we also completed an intake survey that collected medical history and demographics, as well as LSIA and PHQ-9. Both validated outcome measures. Now, LSIA is a 20-item survey asking about the level of satisfaction of individuals' physical and psychological health. As for PHQ-9, it's a screening tool for depression. Also at enrollment, participants were instructed to contact the research staff during business hours from discharge all the way to six months, and participants received a response within 24 hours, as you can see in the flowchart under months one through six. Fairly easy instructions for patients. And at month one in the yellow column, we collected a follow-up questionnaire on telemedicine and clinical utilization, such as ER, which took about 20 minutes. We also added the reintegration into normal living index, which is also a validated outcome measure, and it's an 11-item survey that assesses how well patients have adjusted back in their community, which is why it's done at month one. At month two through five, in the blue columns, the same questionnaires were collected as month one, except for RNLI. Now, at month six, in the green column, all of the questions were collected with an added satisfaction survey, which took about 30 minutes. And so after participation, participants wanting to continue with FaceTime telemedicine appointments were instructed to call the outpatient rehab clinic. Participants kept all their equipment except for their six-month data plan, and at that point, Wi-Fi could be used, home Wi-Fi could be used. And so participants who volunteered for the study were recruited from inpatient and outpatient setting and had to be, over the age of 18, fluent in English, residing in California, diagnosed with an SCI at any neurological and impairment level, and approved by an SCI specialist. Overall, the study recruited 83 participants. So as SciPAD study had no mandated minimum number of telemedicine per participant, not all participants elected to use FaceTime telemedicine. Table one shows the participants' demographic based on who did use telemedicine, FaceTime telemedicine. Now, the no FaceTime telemedicine group were individuals who did not engage in a FaceTime appointment, although they may have used other services associated with SciPAD. For instance, some participants in that group just submitted refill requests. So overall, there were similar demographic characteristics between the groups. The average age was 41 years old of age. Most were male, Caucasian, with traumatic etiologies. There were no differences in injury and marital status. Also half of our participants had an education level greater than high school, and most were working before their injury. There were also no significant differences in areas of social behavior and technology use. On the right side, in-person clinical utilization rates are shown in figures four through six. A total of 65 ER and 25 hospitalizations were reported over the course of the study, and these tended to decrease over time. Bladder and bowel concerns were actually the leading causes of ER visits. Most visits to clinicians were to APCP at 36%, followed in lower frequencies by surgery, urology, and physiatry. So over the course of the study, participants in SciPAD attended 198 telemedicine appointments, and study personnel responded to over 1,000 phone and email triages. As shown in table one on slide two, 62 of 83 were FaceTime TM users. 30 of our participants were recruited from inpatient setting, and more participants in the no TM group discontinued study participation. Now the top five topics discussed at our telemedicine appointments were general follow-up, bladder, bowel, neurological, and pain. In table three, you'll see there were no significant differences found in outcome measures, ER, physician, and hospitalization utilization, but seeking SEI advice from clinicians within and outside of our network was significantly higher in the FaceTime TM group. Now for table four, that shows our patient satisfaction data for the FaceTime TM users. Overall, TM users were highly satisfied with their study participation, 89% satisfied with the TM provided and equipment, 71% satisfied with perceived health, and 100% satisfaction with staff. We also received a lot of anecdotal evidence like one, the one you see on the slides, on the slide. So overall, the SciPAD study provides a feasible approach in providing care via iPad FaceTime for persons with SEI. Although ER hospitalizations and in-person physician utilizations were not significant, people did, or participants did seek advice from our clinicians within and outside of our network. I just want to say thank you for your time today. If you have any questions, please let me know. Again, if anybody has any questions for anybody, please leave the question in the Q&A section on the left side of your screen. Thank you again to Ms. Kong and a virtual round of applause for her. Next we have Dr. Michael Guthrie. He's a third-year resident at the UPMC Physical Medicine Rehabilitation Residency Program in Pittsburgh, Pennsylvania. He grew up in Cincinnati, and he has a BS in biomedical engineering. Today he's going to talk about sleep symptom associations with clinical outcomes in concussion and Dr. Guthrie's presentation. Hello. My name is Michael Guthrie, and my project was entitled Sleep Symptoms Associated with Poor Clinical Outcomes Following Concussion. So sports-related concussion is a particular medical concern. It affects millions of athletes every year. And specifically, our project, we wanted to look at the association of sleep symptoms with concussion outcomes. So we know that sleep disorders are common in concussion population. They can present as early as the acute stages of recovery, and they can persist for up to a year following an initial concussion. And we've also seen that prior research demonstrates that there is risk for worse neurocognitive function following concussion in those with impaired sleep. We know that sleep and activity changes immediately following concussion are important in predicting specific recovery trajectories. For example, sleep disturbances after concussion have been associated with more symptom reporting, as well as the neurocognitive impairments. So what is unknown about sleep in the acute stages of recovery of concussion is exactly how do we understand clinically when sleep impairment is present. There's many measures to determine sleep impairment. And one such measure is the post-concussive symptom scale, which includes five items on sleep-related symptoms, including insomnia, hypersomnia, fatigue, drowsiness, and troubles getting to sleep. It's unclear what the exact utility of these questions are for our concussion population in terms of their outcomes, specifically with vestibular and ocular motor outcomes. This is poorly defined previously. So the objectives of our study was to determine sleep-related clinical outcome measures in a sports-related concussion population. And we hypothesized that those with more significant sleep impairments in the acute stages of recovery will also demonstrate more overall symptom reporting, worse neurocognitive function, worse vestibular-ocular motor testing, as well as prolonged recovery times. So this was a retrospective chart review of 162 athletes, ages range from 12 to 22 years old. And we examined them in their initial clinic visit to a concussion specialty clinic to determine various outcome measures. So those with moderate and severe traumatic brain injury and those with premorbid vestibular-ocular dysfunction or prior neurologic disorders were excluded from the study. We did collect baseline medical history information, including those with history of headache disorders, psychiatric disorders, learning disabilities, and other baseline information, just like their age and their history of prior concussions. In looking at the recovery time, we used it defined as consensus guidelines as being asymptomatic or returning to pre-injury level of cognitive function and symptom reporting at baseline with no exacerbation in their symptoms after exertion. So the clinical outcome measures that we looked at, for one, was the PCSS, which, in addition to the sleep-related items, includes other symptoms commonly reported in concussion in the physical, cognitive, and affective aspects, rated on a 0 to 6 scale, with 0 being no symptoms and 6 being severe symptoms. This takes about 2 to 3 minutes to complete in a clinic setting. For neurocognitive testing, we use the IMPACT, which stands for Immediate Post-Concussion Assessment and Cognitive Testing. This is a little more involved. It has various questions that results in four composite scores for verbal memory, visual memory, visual motor processing speed, and reaction time. Higher scores indicate better performance in all except reaction time. This takes about 20 to 30 minutes to complete. Finally, we looked at the vestibular ocular motor screening tool, which assesses symptom reporting at baseline and after physical exam maneuvers, including smooth pursuits, both horizontally and vertically, horizontal and vertical saccades, vestibular ocular reflexes in both the horizontal and vertical direction, near point of convergence, and visual motion sensitivity. So overall, our participants, the average age was 15.3 years old, and their initial time to clinic visit was 6.8 days, so just within a week. The median sum of all sleep-related scores on the PCSS for individuals was 6, thus we did a median split where any individual who scored 6 or above on those sleep-related items was considered to be in the high sleep symptom group, and anybody that scored 0 to 5 was in the low sleep symptom group. There was no difference in the two groups between their age or their time to initial clinic visit. We did identify a significant difference in the percentage of males between the low and high sleep symptom group, being that there was 53% of the low sleep symptom group were males compared to 38% of the high sleep symptom group. And then we also found in the premorbid risk factors in our Table 1 that there was a significant higher percentage of those with a personal psychiatric history in the high sleep symptom group compared to the low sleep symptom group when using chi-squared analyses. Otherwise, the premorbid medical conditions were pretty similar across the board. In looking at the outcome measures, we did see that overall, the non-sleep-related symptoms were higher scores, indicating more symptom reporting in the high sleep symptom group compared to the low sleep symptom group. Furthermore, in the impact testing, we saw impairments in their verbal memory as well as processing speed that was significantly different between the high sleep symptom groups and the low group. There was no statistical difference between recovery time and days, although there was a very wide variance in these measures. And then looking at the vestibular-ocular screening cutoffs. We used a cutoff above a score of 2 for each physical exam maneuver to determine what was clinically significant symptom exacerbation for that particular test. And we did find that for smooth pursuits and horizontal saccades, both of those exam items did show a significantly higher group, significantly higher percentage in the high sleep symptom group that were above those clinical cutoffs in our Table 3 there. So overall, we found that consistent with prior research, those with more sleep impairments following concussion had overall more symptom reporting. They also demonstrated impaired neurocognitive function in a couple of the domains on impact testing. We stand on our understanding of previous research showing that they also had impairments in vestibular-ocular motor screening. Overall, this suggests, emphasizes the need to screen those for sleep impairment in the early stages of recovery of concussion and use these clinical outcome measures to track progress and recovery over time with the hope that specific interventions may improve recovery trajectory in sports-related concussion. Thanks. Thank you, everybody. This is – these are all our presentation – that was all our presentations for today. We are available for live Q&A right now. Dr. Topman, we have a question for you first. Could you look at the trends of discharge disposition? Yes, so the UDSMR does contain data for percentage of patients discharged to the community. And this trend was less linear than the other trends that I presented, but there was a decrease overall over the time period of about 5%. That's from about 46% to 41%. Excellent. Dr. Roth, you had a question for Dr. Betho, and Dr. Wagner is here for Dr. Betho. She's an Associate Director of Medical Affairs with Greenwich Biosciences. Do you want to read your question, Dr. Roth? Yeah, I wanted to know if you know whether the TARDU and or the Modified Ashworth Scale were tested, and if not, would that be a plan for a future study? Sure. Hi. I'd be happy to answer that. So yes, either the Ashworth or the Modified Ashworth Scale were included in the three studies that were presented today. For the first study, the 106, the Ashworth was actually an inclusion criteria where individuals had to have a greater than 2 on Ashworth and 2 more muscles. So we've had inconsistent findings with the Modified Ashworth Scale with no significant difference between treatment versus placebo in the 106 study, a trend in the 604 study, and then a significant improvement in the MAS in the Savant study in both upper extremity and lower extremity muscles. We have announced recently that we planned three Phase 3b randomized control studies and MS spasticity focused on tone, and those will be using the Modified Ashworth Scale. In addition, we've announced plans to study one Phase 3b study in spinal cord injury spasticity using the Modified Ashworth Scale. Thank you. Excellent. Does that answer your question? Thank you. Yes. Thanks. You're welcome. The next question is from Nathaniel Meyer, Dr. Roth. How do you know the spinal cord was affected? Couldn't your input stem of skin go to the brain? Yeah, it's an interesting thought. As we think about the mechanism of action of how this works, this is obviously all conjecture. It's all sort of just our suppositions about this. I suppose it's possible that the surface stimulation goes from the skin directly to the brain. It just seems unlikely that that's going to then have to travel back down and then affect the spinal cord. A very important element of this is we've spent a lot of time testing different positions and actually different parameters of the stimulation, but mostly different locations within the spine for the stimulation and found that the ones that I mentioned, there were three locations, actually works the best, although we're still testing this out. So it really suggests that actually it's somewhat, to some extent, proximity to the portion of the spinal cord that controls the very specific muscles that we're looking for that would sort of have the influence. Excellent. Thank you, Dr. Roth. For Ms. Kong, this is from David Spanier. Could you tell me more about the iPad and software you used to form the telemedicine visits? Did you find a lot of technical issues that had to be addressed or was it pretty plug and play? We have struggled with telemedicine various ways during the pandemic. I know I have as well in my practice. Thank you for the question, David. So for the iPad, it pretty much comes ready. For FaceTime, it's just like a regular phone call with a phone number or email, I guess, for FaceTime, and then there's the call and end button. But before the patient discharges or even before we give the iPad to the participant, we make sure that the iOS software updates are turned on. So it's constantly updating during the six-month participation. And of course, after participation as well, they can choose to turn it off. We did have a couple of connectivity issues, but because we use Verizon and Verizon has pretty good coverage in California, it was rare. And in those situations where we did have connectivity issues, which is the number one technical issue we had, we would just switch to phone until next time when there was a better connection. Okay. Thank you. We have about eight minutes left. I have three more questions here. I'm going to try to help everybody can answer these. This one I think is for Dr. Guthrie. What do you recommend to address sleep impairment and head injury given potential cognitive impact of medications? This is from Dr. Kraft. Thanks. Yeah. So certainly there could be side effect profiles of some of the sleep aids that we're using. But I think an even easier first step of intervention would be sleep hygiene education and implementing that in a way early on because in our study, we saw patients within the first week of their concussion and if we were able to simply just track their sleep habits over time and give recommendations for how they could improve sleep patterns, especially in the younger population, this may be just as impactful as medication use and certainly would be the first step that we would do before reaching into prescription medicines. Excellent. The next one is also for you, Dr. Guthrie. This is from Dr. Bell, Kathleen Bell. Dr. Guthrie, did you collect any data on the use of neurostimulants and antidepressants in this population? Also any screening in the clinic for affective disorders? Yeah. So rather than looking at use of those medications, we just screen for the presence of learning disability or prior psychiatric history, which I think maybe captures some of that. But it would be interesting to look at differences in sleep patterns amongst those who are on specific medications, certainly in an area of future. to research to look at, you know, even introducing new medications and how that would affect people's sleep patterns in the recovery of concussion. Excellent, thank you. This question is for Dr. Totman from Dr. Mark Ellen. Dr. Totman's study reveals both decreasing LOS and DC with lower FIMS scores. What do you attribute this to and how do we release the, reverse the trend if possible? Thank you for the question. I think this is a really important piece of what the study reveals and certainly concerning. I think one possibility is that it's due to changing insurance practices. One piece that we're missing is whether is really discharge disposition, which was what the other question was asking about. We do have the percent of patients discharged to the community, but that's somewhat limiting. So I think looking at where all of these patients are going at discharge would be a really relevant follow-up question for this study. Thank you, Dr. Totman. And I have one more question here for Dr. Guthrie again. Do you think objective measure of sleep, such as a sleep lab or wearable device like Fitbit might be helpful in looking at post-concussion sleep disturbance? Absolutely. That's a great idea. And actually they've validated actigraph devices like a Fitbit to be a pretty close proxy to overall objective sleep measures that even both standards like polysomnography. So I think that that would be useful and then kind of stealing from the CYPAD project in incorporating like an ideal way to track sleep in real time and give information bi-directionally from provider to patient and be able to keep updated on exactly sleep patterns and how it's affecting their recovery. Thank you. Great. Thank you, Dr. Guthrie. Does anybody have any more questions? Otherwise we are just about done here. Great. Well, thank you everybody for being here and thank you guys for your presentations. Appreciate it. And hope you have a wonderful rest of the weekend. And we'll see you in 2021 and hopefully in person. Thank you. Thank you. Thanks. Goodbye.

AAPM&R Conference 2020

rehabilitation patient population

traumatic brain injury

non-invasive spinal stimulation

gait function

concussion

telemedicine

spinal cord injury

sleep impairments