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Brain Concussion clinical trials

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NCT ID: NCT04760834 Recruiting - Cerebral Concussion Clinical Trials

Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players

RUGBY-COM
Start date: March 16, 2022
Phase:
Study type: Observational

Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.

NCT ID: NCT04731974 Recruiting - Pediatric ALL Clinical Trials

Acute Concussion and Melatonin

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.

NCT ID: NCT04688255 Recruiting - Clinical trials for Brain Injuries, Traumatic

Mobile Subthreshold Exercise Program for Concussion--R01

MSTEP-R01
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.

NCT ID: NCT04582682 Recruiting - Concussion, Mild Clinical Trials

Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion

Start date: January 18, 2021
Phase:
Study type: Observational

The purpose of this study is to identify changes in salivary micro ribonucleic acid (miRNA) levels that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.

NCT ID: NCT04576715 Recruiting - Clinical trials for Mild Traumatic Brain Injury

TBI Evaluation and Management (TEaM)

TEaM
Start date: August 19, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a multi-disciplinary, multi-setting intervention with the goal of improving outcomes for children who have experienced a mild traumatic brain injury (mTBI). The project aims to improve and support mTBI diagnosis and management, and improve critical decision making by clinicians during their interaction with the injured child, their family, and their school.

NCT ID: NCT04543162 Recruiting - Clinical trials for Traumatic Brain Injury

Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)

Biotraumap
Start date: October 2, 2019
Phase:
Study type: Observational

The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal. The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI. The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.

NCT ID: NCT04540445 Recruiting - Clinical trials for Brain Injuries, Traumatic

Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children

Start date: March 11, 2020
Phase:
Study type: Observational

The purpose of this study is to gather information and compare the potential use of pupillometry to identify concussions and post concussive syndrome with standard age appropriate assessments. The study will compare concussed pediatric patients 5-17 years of age recruited from the emergency department within 72 hours following injury with age and gender matched non-concussed pediatric patients recruited from primary care clinics. Assessment of both concussed and non-concussed subjects will take place at the initial enrollment visit and will be repeated at 1-2 weeks for the concussed subjects and at 12-14 weeks for both groups.

NCT ID: NCT04423198 Recruiting - Clinical trials for Mild Traumatic Brain Injury

HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

HeadSMART II
Start date: December 31, 2020
Phase:
Study type: Observational

The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.

NCT ID: NCT04372797 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

This study will establish the capability of a suite of conventional tests and the Neurolign Dx_100 I-PAS goggle system to reliably and objectively detect mTBI in an acute setting when comparing individuals with mTBI to controls with minor injuries in a similarly stressful environment.

NCT ID: NCT04279431 Recruiting - Concussion, Brain Clinical Trials

Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One

MEDO
Start date: May 25, 2020
Phase:
Study type: Observational

The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.