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To describe CONCUSS, a randomized clinical trial (RCT) designed to compare the following: the effectiveness of immediate office-based vergence/accommodative therapy with movement (OBVAM) to delayed OBVAM as treatments for concussion-related convergence insufficiency (CONC-CI) to understand the impact of time (watchful waiting), the effect of OBVAM dosage (12 versus 16 therapy sessions), and to investigate the underlying neuro-mechanisms of OBVAM on CONC-CI participants. CONCUSS is an RCT indexed on https://clinicaltrials.gov/study/NCT05262361 enrolling 100 participants aged 11-25 years with medically diagnosed concussion, persistent post-concussive symptoms 4-24 weeks post-injury, and symptomatic convergence insufficiency. Participants will receive standard concussion care and will be randomized to either immediate OBVAM or delayed (by six weeks) OBVAM. At the Outcome 1 examination (week 7), clinical assessments of success as determined by changes in the near point of convergence (NPC), positive fusional vergence (PFV), and symptoms will be compared between the two treatment groups. After the Outcome 1 visit, those in the delayed group receive 16 visits of OBVAM, while those in the immediate OBVAM group receive four more therapy visits. Outcome 2 assessment will be used to compare both groups after participants receive 16 sessions of OBVAM. The primary measure is the between-group differences of the composite change in the NPC and PFV at the Outcome 1 visit. Secondary outcome measures include individual clinical measures, objective eye-tracking parameters, and functional brain imaging. Major features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a delayed treatment arm, masked outcome examinations, and the incorporation of objective eye movement recording and brain imaging as outcome measures. CONCUSS will establish best practices in the clinical care of CONC-CI. The objective eye movement and brain imaging, correlated with the clinical signs and symptoms, will determine the neuro-mechanisms of OBVAM on CONC-CI.

Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) history have high rates of performance validity test (PVT) failure. The study aimed to determine whether those with scores in the invalid versus valid range on PVTs show similar benefit from psychotherapy and if psychotherapy improves PVT performance. Veterans (N = 100) with PTSD, mild-to-moderate TBI history, and cognitive complaints underwent neuropsychological testing at baseline, post-treatment, and 3-month post-treatment. Veterans were randomly assigned to cognitive processing therapy (CPT) or a novel hybrid intervention integrating CPT with TBI psychoeducation and cognitive rehabilitation strategies from Cognitive Symptom Management and Rehabilitation Therapy (CogSMART). Performance below standard cutoffs on any PVT trial across three different PVT measures was considered invalid (PVT-Fail), whereas performance above cutoffs on all measures was considered valid (PVT-Pass). Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group. Measures of post-concussive and depressive symptoms improved to a similar degree across groups. Treatment condition did not moderate these results. Rate of valid test performance increased from baseline to follow-up across conditions, with a stronger effect in the SMART-CPT compared to CPT condition. Both PVT groups experienced improved psychological symptoms following treatment. Veterans who failed PVTs at baseline demonstrated better test engagement following treatment, resulting in higher rates of valid PVTs at follow-up. Veterans with invalid PVTs should be enrolled in trauma-focused treatment and may benefit from neuropsychological assessment after, rather than before, treatment.

Repeated sub-concussive head impacts are a growing brain health concern, but their possible biomarkers remain elusive. One impediment is the lack of a randomised controlled human experimental model to study their effects on the human brain. This work had two objectives. The first one was to provide a randomised controlled human experimental model to study the acute effects of head impacts on brain functions. To achieve this, this work's second objective was to investigate if head impacts from heading footballs acutely alter brain excitability by increasing corticospinal inhibition as compared to a control group. In practised and unpractised young healthy adults, transcranial magnetic stimulation was used to assess corticospinal silent period (CSP) duration and corticospinal excitability (CSE) before and immediately after performing headings by returning 20 hand-thrown balls directed to the head (Headings; n = 30) or the dominant foot (Control; n = 30). Moreover, the Rivermead Post-Concussion Questionnaire (RPQ) was used to assess the symptoms of head impacts. Head acceleration was also assessed in subgroups of participants. The intervention lengthened CSP duration in both the Headings (6.4 ± 7.5%) and Control groups (4.6 ± 2.6%), with no difference in lengthening between the two groups. Moreover, CSE was not altered by the intervention and did not differ between groups. However, performing headings increased headaches and dizziness symptoms and resulted in greater head acceleration upon each football throw (12.5 ± 1.9g) as compared to the control intervention (5.5 ± 1.3g). The results suggest that head impacts from football headings do not acutely alter brain excitability as compared to a control intervention. However, the results also suggest that the present protocol can be used as an experimental model to investigate the acute effects of head impacts on the human brain.

Avoiding recurrent injury in sports-related concussion (SRC) requires understanding the neural mechanisms involved during the time of recovery after injury. The decision for return-to-play is one of the most difficult responsibilities facing the physician, and so far this decision has been based primarily on neurological examination, symptom checklists, and neuropsychological (NP) testing. Functional magnetic resonance imaging (fMRI) may be an additional, more objective tool to assess the severity and recovery of function after concussion. The purpose of this study was to define neural correlates of SRC during the 2 months after injury in varsity contact sport athletes who suffered a SRC. All athletes were scanned as they performed an n-back task, for n=1, 2, 3. Subjects were scanned within 72 hours (session one), at 2 weeks (session two), and 2 months (session three) post-injury. Compared with age and sex matched normal controls, concussed subjects demonstrated persistent, significantly increased activation for the 2 minus 1 n-back contrast in bilateral dorsolateral prefrontal cortex (DLPFC) in all three sessions and in the inferior parietal lobe in session one and two (α≤0.01 corrected). Measures of task performance revealed no significant differences between concussed versus control groups at any of the three time points with respect to any of the three n-back tasks. These findings suggest that functional brain activation differences persist at 2 months after injury in concussed athletes, despite the fact that their performance on a standard working memory task is comparable to normal controls and normalization of clinical and NP test results. These results might indicate a delay between neural and behaviorally assessed recovery after SRC.

Objectives: The current study aimed to examine if televised media about mild traumatic brain injury (mTBI) framed in a sensationalized manner had a negative impact on cognitive functioning and persistent mTBI symptoms. Methods: One hundred two participants (M Age=37.16; SD=22.61) with a history of post-acute mTBI, recruited through a community research registry and an undergraduate recruitment system, were included in this study. Participants were assessed with a measure of health literacy, the Short Test of Functional Health Literacy in Adults (S-TOFHLA), and randomized to watch either a sensationalized or non-sensationalized news clip focused on mTBI. They were then assessed with the Paced Auditory Serial Addition Test (PASAT), Rivermead Post Concussion Symptoms Questionnaire (RPQ), Patient Reported Outcome Measures Information System (PROMIS) Depression scale, and the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (PCL-5). Results: Bayesian analyses indicated that sensationalized media—alone (β PASAT=−0.08; β RPQ=−0.08) or in the context of covariates (β PASAT=−0.11; β RPQ=−0.14)—was not a strong predictor of PASAT score or post-concussion syndrome symptom severity. Conclusions: Although media sensationalization of mTBI symptoms is not desirable, this study suggests that one brief exposure to sensationalized information may not have a meaningful immediate impact on the cognitive functioning or symptom reporting of individuals with a history of mTBI. Future research should examine long-term and downstream effects of sensationalized media reporting in samples with greater diversity of TBI history. (JINS, 2019, 25, 90–100)

Current assessment tools for sport-related concussion are limited by a reliance on subjective interpretation and patient symptom reporting. Robotic assessments may provide more objective and precise measures of neurological function than traditional clinical tests. To determine the reliability of assessments of sensory, motor and cognitive function conducted with the KINARM end-point robotic device in young adult elite athletes. Sixty-four randomly selected healthy, young adult elite athletes participated. Twenty-five individuals (25 M, mean age±SD, 20.2±2.1 years) participated in a within-season study, where three assessments were conducted within a single season (assessments labeled by session: S1, S2, S3). An additional 39 individuals (28M; 22.8±6.0 years) participated in a year-to-year study, where annual pre-season assessments were conducted for three consecutive seasons (assessments labeled by year: Y1, Y2, Y3). Forty-four parameters from five robotic tasks (Visually Guided Reaching, Position Matching, Object Hit, Object Hit and Avoid, and Trail Making B) and overall Task Scores describing performance on each task were quantified. Test-retest reliability was determined by intra-class correlation coefficients (ICCs) between the first and second, and second and third assessments. In the within-season study, ICCs were ≥0.50 for 68% of parameters between S1 and S2, 80% of parameters between S2 and S3, and for three of the five Task Scores both between S1 and S2, and S2 and S3. In the year-to-year study, ICCs were ≥0.50 for 64% of parameters between Y1 and Y2, 82% of parameters between Y2 and Y3, and for four of the five Task Scores both between Y1 and Y2, and Y2 and Y3. Overall, the results suggest moderate-to-good test-retest reliability for the majority of parameters measured by the KINARM robot in healthy young adult elite athletes. Future work will consider the potential use of this information for clinical assessment of concussion-related neurological deficits.

Background Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown et al. JAMA Pediatr 172(11):e182853, 2018; Lumba-Brown A et al. JAMA Pediatr 172(11):e182847, 2018). We have developed a collaborative care intervention with embedded cognitive-behavioral therapy, care management, and stepped-up psychotropic medication consultation to address persistent PCS and related psychological comorbidities. The CARE4PCS-II study was designed to assess whether adolescents with persistent symptoms after sports-related concussion will demonstrate better outcomes when receiving this collaborative care intervention compared to a usual care (control) condition. Methods/design This investigation is a randomized comparative effectiveness trial to receive intervention (collaborative care) or control (usual care). Two hundred sports-injured male and female adolescents aged 11–18 years with three or more post-concussive symptoms that persist for at least 1 month but less than 9 months after injury will be recruited and randomized into the study. The trial focuses on the effects of the intervention on post-concussive, depressive, and anxiety symptoms measured 3, 6, and 12 months after baseline. Discussion The CARE4PCS II study is a large comparative effectiveness trial targeting symptomatic improvements in sports injured adolescents after concussion. The study is unique in its adaptation of the collaborative care model to a broad spectrum of primary care, sports medicine, and school settings. The investigation incorporates novel elements such as the delivery of CBT through HIPAA complaint video conferenceing technology and has excellent widespread dissemination potential should effectiveness be demonstrated. Trial registration ClinicalTrials.gov, NCT03034720 . Registered on January 27, 2017.

Abstract OBJECTIVE The relationship between athlete reports of symptoms, neurophysiological activation, and neuropsychological functioning is investigated in a sample of high school athletes. METHODS All athletes were evaluated using functional magnetic resonance imaging (fMRI), a computer-based battery of neurocognitive tests, and a subjective symptom scale. Athletes were evaluated within approximately 1 week of injury and again after clinical recovery using all assessment modalities. RESULTS This study found that abnormal fMRI results during the first week of recovery predicted clinical recovery. As a group, athletes who demonstrated hyperactivation on fMRI scans at the time of their first fMRI scan demonstrated a more prolonged clinical recovery than athletes who did not demonstrate hyperactivation at the time of their first fMRI scan. CONCLUSION These results demonstrate the relationship between neurophysiological, neuropsychological, and subjective symptom data in a relatively large sample composed primarily of concussed high school athletes. fMRI represents an important evolving technology for the understanding of brain recovery after concussion and may help shape return-to-play guidelines in the future.

Background Recent data suggest that 10–20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months. Methods This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (≥18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group. Discussion In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge. Trial registration Clinical Trials. NCT03400813 . Registered 17 January 2018 – retrospectively registered.

Background After mild traumatic brain injury (TBI), discharge from the emergency department (ED) relies on clinical examination and brain imaging, but triaging of these patients can be challenging in specific situations. Transcranial Doppler (TCD) after mild TBI may rule out early neurologic worsening. We hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. Methods This is a prospective, open-label, multisite, randomized controlled noninferiority trial. Eligible patients are mild TBI patients (Glasgow Coma Scale, GCS, 13–15 on admission) with minor lesions on brain CT scan or normal CT scan but one of the following risk factors: (1) GCS = 14 after CT scan; (2) alcoholic intoxication, (3) ongoing treatment with anticoagulants or anti-platelet therapy; (4) persisting nausea, vomiting, and/or headaches; or (5) early initial CT scan (< 4 h after TBI). Patients randomized in the intervention group have TCD within 12 h after TBI and can be immediately discharged from the ED if TCD is normal (diastolic flow velocity higher than 25 cm/s and pulsatility index lower than 1.25). Discharge of patients in the control group relies on clinical examination and brain imaging only. The primary outcome is the 3-month neurological outcome measured with the Extended Glasgow Outcome Scale (GOS-E). Secondary outcomes are the GOS-E at 1 month, the QOLIBRI (Quality of life after TBI) and EQ-5D-5L questionnaires at 1 month and 3 months after TBI, the Rivermead Post-Concussion Symptoms questionnaire at 1 month and 3 months after TBI, mortality within the first 3 months, the number of cerebral CT scans, length of stay in hospital, the number of thromboembolic events or diagnosed nosocomial infections, and the number of patients re-admitted to hospital in relation with the initial TBI. Inclusions have started in February 2020 and are expected to be complete by June 2025. Discussion Transcranial Doppler in mild TBI patients may help immediate discharge from the ED after CT scanning. Trial registration This study has been prospectively registered on clinical trial on June 14, 2019, NCT03989999.