View clinical trials related to Brain Concussion.
Filter by:The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI). The main questions this comparative pilot study aims to answer are: - Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI? - Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery? Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including: - gaze stabilization - dual-task balance training - spatial navigation - agility training Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group. Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.
Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road. The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9. Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery. To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total). This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.
This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Findings will provide novel insights into the longer-term effects of concussion on children's physical, psychological, and social well-being and support the development of personalized healthcare and school-based plans to reduce disparities in children's ability to return-to-learn and -play and improve postconcussion quality of life.
Diagnosing and determining the severity of a sports-related concussion immediately on- or off-field is challenging, especially because clinical signs can evolve minutes to hours after the mechanism of injury. Hence, repeated follow-up and serial assessments of a player are recommended following such an injury. Current advice, when a player sustains a confirmed or suspected concussive injury, is to remove them from play immediately and not return to competition or unrestricted training until signs and symptoms have been managed as per relevant guidelines. To support this decision the International football Association Board has introduced a trial allowing an additional permanent concussion substitution in participating competitions. Follow-up assessment of concussion incidents is recommended to include the Sport Concussion Assessment Tool 5th Edition. For further assessment of neurocognitive deficits and to inform return to play decisions, it is recommended that a computerised assessment is also adopted, such as the Immediate Post-Concussion Assessment and Cognitive Testing tool. The aims of this study are: 1. To determine the incidence of head trauma and use of concussion substitutions in football competitions that are participating in the IFAB's permanent concussion substitution trial. 2. To evaluate the immediate severity of reported concussion signs and symptoms for football players with a confirmed or suspected concussion. 3. To evaluate the ability of neurocognitive assessments completed post-incident to inform the clinical diagnosis of concussion.
The primary objective is to provide normal concussion assessment references values for use in football. All National Football Associations participating in The International Football Association Board's additional permanent substitutions trial are requested to provide baseline assessment data from players within their competitions
The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings. The EBLens will be based on a concussion diagnostic algorithm from the FDA cleared EyeBOX device, developed by Oculogica, and eye-tracking data collected from a wearable set of eye-tracking glasses, developed by Adhawk Microsystems. Once the EBLens is prototyped, an algorithm for diagnosing concussion will be developed that is specifically appropriate for the EBLens via a case-control clinical study comparing 100 concussed to 100 non-concussed subjects (Phase I). Participants, age 18-35 years, will be recruited from the KACH research team and affiliated providers and clinical sites. Concussed individuals will be assessed within 72 hours of concussion. Demographics, basic medical history, symptom severity, a visio-vestibular exam and the EBLens scan will be collected on both injured cases and uninjured controls at a single time point. The algorithm and the EBLens will be validated in a subsequent, prospective cohort validation study (Phase II) designed for FDA submission. The correlation of the EBLens output with resolution of symptoms will also be observed in longitudinal follow-up of concussed participants in the validation study. The participant population for this study will be cadets recruited from the USMA and young athletes recruited from affiliated sites during baseline concussion testing. Participants will be assessed at baseline at the start of their academic year or sports season. Those participants who experience a concussive injury will be assessed again at three time points; 1) within 72 hours of injury, 2) weekly until and at the time of initiation of a graded return to activity protocol, and 3) upon clearance for unrestricted RTP/RTD.
Using the Consolidated Framework for Implementation Research, as our overarching conceptual framework, this translational 2 ½ year pragmatic RCT uses a clustered, stepped wedge design to test the effectiveness of a school-based (unit of analysis) implementation strategy (project intervention) called RISE (Return to Learn Implementation bundle for schools) on evidence-based practice (RTL protocol implementation; main outcome) and student outcomes (i.e., days to RTL start after diagnosis) after youth concussion. The central hypothesis is that schools in the intervention condition receiving the RISE implementation bundle (toolkit plus school support) will have more complete and sustainable RTL protocols, and better student outcomes compared to schools in control condition who receive only written RTL protocol information. As rural and low SES schools are particularly likely to struggle to implement RTL protocols,19,25 we specifically examine RISE implementation and barriers to implementation related to school demographic characteristics related to health equity. The school characteristics we examine are rurality, primary language, racial and ethnic mix, and free/reduced-cost lunch.
The purpose of this 5-year prospective research study is to characterize the association between concussions, sub-concussive exposure, and long-term neurologic health outcomes in former NFL players. To achieve the study aims, the investigators will conduct detailed research visits that include clinical outcome assessments, blood-based biomarkers, advanced magnetic resonance imaging (MRI), positron emission tomography (PET) using investigational tracers and genetic testing. Ultimately, the goal of this study is to translate the findings from this study into clinical, interventional studies for at risk former NFL players.
The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.
There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. All of them will undergo AD8 questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2. 10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for AV45 amylid PET study. There will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.