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Concussion, Mild clinical trials

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NCT ID: NCT03653195 Completed - Concussion, Mild Clinical Trials

Diagnosis of Sport-related Concussion Using Urine Metabolites

Start date: August 1, 2010
Phase: N/A
Study type: Interventional

Millions of sport related concussions (SRC) occur yearly in the United States, and current diagnosis of concussion is based upon largely subjective clinical evaluations. The objective of this study is to determine whether urinary metabolites are significantly altered post SRC. Urine of 26 athletes will be analyzed pre-injury and after SRC by 1H NMR spectroscopy. Data will be analyzed using multivariate statistics, pairwise t-test, and metabolic pathway analysis. Variable Importance Analysis based on random Variable Combination (VIAVC) was used to select what features are present out of 224 features. Partial least squares discriminant analysis was performed leading to separation between pre-season and post-SRC groups. A Receiver Operator Curve (ROC) curve will be constructed to classify the features. Pathway topology analysis will also be completed to determine biological pathways are potentially affected following SRC.

NCT ID: NCT03624634 Completed - Concussion, Mild Clinical Trials

Assessment of the Effects of Concussion on Adolescent Rugby Union Players

Start date: August 1, 2016
Phase:
Study type: Observational

200 adolescent rugby players (aged 15-19) from the Senior Cup Teams of 5 Rugby Playing schools (Members of Irish Schools Rugby) will be invited to enroll for inclusion in the study. The study will collect data on brain health, including computer based skill testing, eye tracking and balance and on task completion, cover existing tests in the established SCAT 3 alongside response to exercise testing and a clinical examination including baseline blood tests known to influence recovery from concussion in a rugby playing population of adolescent schoolboys. The initial data will be taken before the 2016/2017 season starts. The volume of rugby training and match play will be recorded along with activity monitoring in general. For those subjects who sustain concussion a dedicated clinic will provide all after care including repeat clinical examination and magnetic resonance imaging along with a graduated return to exercise and a compressive rehabilitation programme at Sports Surgery Clinic (SSC). A Consultant Sports Physician will manage the return to play programme with an exercise, cognitive, balance, eye movement and neck strength programme.

NCT ID: NCT03544372 Completed - Concussion, Mild Clinical Trials

Reliability of Self-reported Concussion History in Current Rugby Union Players

Start date: March 15, 2017
Phase:
Study type: Observational

Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Recent research findings from a cohort of former professional players found that the number of concussions sustained during their professional careers was associated with the rate of diagnosed clinical depression and late-life cognitive impairment. A limitation of these studies is the use of a self-reported history of concussion. The reliability of professional rugby players to recall and self-report concussion history has never been quantified in the literature to date. Imperfect recall can generate bias in epidemiologic studies when the proportion of events recalled is associated with the health end points of interest. Associations observed may be spurious and due to recall bias if athletes differ in their knowledge and recognition of concussion symptomology in a manner that is associated with the health outcome of interest ie. under/overreporting of concussion. It is difficult to estimate the magnitude of the bias in the absence of any "gold-standard" measure of concussion history. Due to these concerns about the quality of self-reported concussion history, the investigators considered that it was important to evaluate the reliability of self-reported concussion history.

NCT ID: NCT03306563 Completed - Clinical trials for Traumatic Brain Injury

Rapid Biochemical Diagnostics of Traumatic Brain Injury

Start date: December 28, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.

NCT ID: NCT03265912 Completed - Clinical trials for Mild Traumatic Brain Injury

Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment

Start date: January 26, 2017
Phase:
Study type: Observational

mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. This study purpose is to study this BNA technology in individuals who have sustained a concussion.

NCT ID: NCT03236389 Completed - Concussion, Mild Clinical Trials

Brain Dynamics in Response to Jugular Vein Compression

Start date: September 2016
Phase: N/A
Study type: Interventional

Clinical trials have suggested that this device is effective in mitigating changes in brain structure and function in athlete populations. The purpose of the current study is to better understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein compression

NCT ID: NCT03214432 Completed - Clinical trials for Mild Traumatic Brain Injury

Return to Work After Mild Traumatic Brain Injury

Start date: July 1, 2017
Phase:
Study type: Observational

Background: Patients with mild traumatic brain injury can to some extend experience long-term physical, cognitive, social and behavioral deficits, which have serious implications for employment trajectories and financial independence. These deficits have shown to be more pronounced in women. High socio-economic position such as income, level of education and employment status before the accident have shown to affect return to work. But also cohabitation status, ethnicity and health are important factors. Previously studies are typically self-report studies, and are often small and may suffer from selection bias due to patient nonresponse. Aim: The aim of this study is to describe no return to work among patients with mild traumatic brain injury in Denmark and to examine how factors such as age, gender, cohabitation status, socio-economic and pre-injury health factors affect no return to work up to 5 years post-injury. Hypothesis: We hypothesize that most patients with mild traumatic brain injury return to work within work 6 months post-injury, and that patients with mild traumatic brain injury injury receive more social transfer payments compared to the general population. Additionally, we hypothesize that low socio economic position, comorbidities and being single are associated with prolonged no return to work. Methods: The present study is an observational national register-based cohort study with long-term follow up of patients with mild traumatic brain injury from 1st of January 2008 - 31st of December 2012 in Denmark. Patients aged 18-60 years diagnosed with concussion from 1st of January 2003-31st of December 2007 in the national patient register will be included in the study. Data will be retrieved from several national databases, including the DREAM database containing data on social benefits and reimbursements. Primary outcome is no-return to work (nRTW) due to any cause and the following four secondary outcomes are graded and should be regarded as a continuum ranging from health related nRTW, limited nRTW, permanently nRTW and mortality. The results will be published as two separate scientific articles.

NCT ID: NCT03195738 Completed - Clinical trials for Mild Traumatic Brain Injury

Feasibility of a Cognitive Intervention for Youth Post Concussion

Start date: July 25, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility and effects of a cognitive intervention for youth following concussion

NCT ID: NCT03170856 Completed - Concussion, Brain Clinical Trials

The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.

NCT ID: NCT03017937 Completed - Concussion, Mild Clinical Trials

Sex and Age Ultrasound Response to Differential Jugular Vein Pressure

Start date: November 2016
Phase: N/A
Study type: Interventional

Clinical trials have suggested that this device is effective in mitigating changes in brain structure and function in athlete populations. The purpose of the current study is to measure the response of the jugular vein to various pressures applied by a generic compression device across various ages and gender. The relative jugular vein response will be measured using ultrasound.