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Concussion, Mild clinical trials

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NCT ID: NCT04248218 Completed - Pediatric ALL Clinical Trials

Concussion Active Rehabilitation

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.

NCT ID: NCT04079907 Completed - Concussion, Brain Clinical Trials

Ketone Supplementation in Adolescents Post-Concussion

Start date: March 20, 2020
Phase: N/A
Study type: Interventional

Adolescent brains undergo rapid and significant changes in structural architecture and functional organization during development. A concussive injury during this developmental period can have substantial physiological and cognitive ramifications. If not adequately managed, adolescent concussions can have profound long-term effects. The purpose of this study is to determine whether ketone supplementation after a concussion will reduce long-term consequences and improve short-term functional status and outcomes in adolescents who have suffered a concussion.

NCT ID: NCT04074486 Completed - Brain Injuries Clinical Trials

Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

BSC-CI-NPC
Start date: October 2, 2019
Phase:
Study type: Observational

This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).

NCT ID: NCT04068883 Completed - Concussion, Mild Clinical Trials

Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar

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

The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation. Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for: - Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL. - Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users. In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.

NCT ID: NCT04036916 Completed - Concussion, Mild Clinical Trials

Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.

NCT ID: NCT03963804 Completed - Clinical trials for Brain Injuries, Traumatic

Objective Brain Function Assessment of mTBI/Concussion

CAS13-25
Start date: June 11, 2018
Phase:
Study type: Observational

This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

NCT ID: NCT03883451 Completed - Concussion, Mild Clinical Trials

Evaluation of Helmet Technology and Head Impact Exposure

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

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes grouped by helmet make and model. Secondly, the purpose is to determine the protection of the helmet make and model relative to amount and magnitude of sustained head impacts.

NCT ID: NCT03791515 Completed - Concussion, Mild Clinical Trials

Clinical Characteristics and Pathophysiology of Post-Traumatic Headache

Start date: July 26, 2018
Phase: N/A
Study type: Interventional

To better understand the clinical characteristics and complex pathophysiological events that constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin gene-related peptide (CGRP) hypersensitivity in PPTH patients.

NCT ID: NCT03678077 Completed - Education Clinical Trials

Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

Start date: September 20, 2018
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status. The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design. Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark. Methods: The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark. Population: Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007). Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM). One control of the general population were matched for each case on sex, age and municipality. Outcome measures are: Cohabitation status, Education, income and socio-economic status.

NCT ID: NCT03671083 Completed - Clinical trials for Brain Injuries, Traumatic

Validation of Brain Function Assessment Algorithm for mTBI/Concussion

CAS13-25V
Start date: October 1, 2018
Phase:
Study type: Observational

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.