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Concussion, Brain clinical trials

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NCT ID: NCT04841473 Completed - Concussion, Brain Clinical Trials

The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

Start date: May 17, 2021
Phase: N/A
Study type: Interventional

Purpose: The purpose of this study is to evaluate the effectiveness of a theory-driven intervention (TRAIN concussion education) to improve parental concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. Participants: 180 parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years. Procedures: The study is a single-blind (participants) randomized control trial. The investigators will randomize eligible parents into two groups: (1) control (standard concussion education); and treatment (standard concussion education AND TRAIN concussion education) to evaluate the effectiveness of the TRAIN concussion education intervention.

NCT ID: NCT04837066 Recruiting - Concussion, Brain Clinical Trials

Dynamic Vision Testing and Concussion Management

Start date: August 31, 2021
Phase:
Study type: Observational

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

NCT ID: NCT04777864 Completed - Concussion, Brain Clinical Trials

Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.

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: NCT04730167 Completed - Brain Injuries Clinical Trials

The Monaco Initiative for Concussion in Motorsport Pilots

Start date: October 5, 2021
Phase:
Study type: Observational

The study aims: - to observe a population particularly exposed by the past to brain trauma and concussion: Motorsport Pilots who are retired from a professional practice of motor sport; - to report results of their neuro-cognitive evaluations, - to determine if specific profiles emerge. - to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level. - to evaluate the contribution of the various examinations performed as part of a concussion assessment in routine care (eye-tracking, brain imaging, Neuropsychological Assessment).

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: NCT04628741 Completed - Clinical trials for Traumatic Brain Injury

Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Up to 28% of undergraduate college students report a suspected history of traumatic brain injury. Following traumatic brain injury, college students fail and repeat more courses and have lower grade point averages. Further complicating this problem may be the fact that college students lack knowledge of traumatic brain injury definition, its associated symptoms, and individuals involved in post-injury management. In this project, the investigators propose to compare the use of an established treatment model (i.e., the Dynamic Coaching Model) to a novel protocol (i.e., the Apprenticeship Approach) that includes explicit instruction about traumatic brain injury in college students with this population. The investigators will use a group comparison design to examine the efficacy of this instructional component. This work incorporates findings from educational psychology and speech-language pathology (e.g., the included instructional materials adhere to the principles of adult learning). As such, this work will advance the field's basic understanding of currently recommended treatment components and will systematically examine the effects of incorporating explicit instruction into an existing treatment model.

NCT ID: NCT04558346 Completed - Clinical trials for Traumatic Brain Injury

Ghrelin (OXE--103) for Acute Concussion Management

Start date: October 20, 2020
Phase: Phase 2
Study type: Interventional

Concussions are the leading form of mild traumatic brain injury. Management of concussions and mild traumatic brain injury is a high priority medical focus, social concern, and research topic. Currently, there are no FDA approved treatments for acute concussion. The current standard of care is rest followed by gradual return to normal activity. The purpose of this study is to show improvement in the way patients feel or function after a concussion. OXE-103 is a protein hormone produced in the laboratory which identical to the hormone ghrelin that is secreted by the stomach. This study will investigate the use of this hormone as treatment for symptoms of acute concussion. The goal of this study is to show improvement in the way study participants feel or function after concussion. An OXE-103 (ghrelin) agonist is already FDA approved for another condition, but not for concussion. For concussion, it is considered investigational. This study will examine, if ghrelin is taken every day for two weeks, if the brain will heal faster and help improve or resolve symptoms. The study will also include a placebo arm and a non-treatment group (for those who wish to participate but do not want to receive any treatment). The OXE-103 and placebo will be self-administered through injections using needles.

NCT ID: NCT04492696 Completed - Concussion, Brain Clinical Trials

Comparison of Concussion Education Programs

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

Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting in prolonged recovery. Athletes' report of concussion symptoms is therefore an important component of risk reduction. Numerous educational interventions to improve concussion knowledge and reporting exist. Objective: Evaluate the comparative efficacy of three concussion education programs in improving concussion-reporting intention. Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment before, immediately after, and one-month after educational intervention.

NCT ID: NCT04426188 Completed - Clinical trials for Traumatic Brain Injury

" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "

Soccer-BRAIN
Start date: June 4, 2020
Phase: N/A
Study type: Interventional

Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired