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Concussion, Brain clinical trials

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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

NCT ID: NCT04381767 Completed - Brain Injuries Clinical Trials

EYE-SYNC Concussion Classification Study

Start date: December 19, 2018
Phase:
Study type: Observational

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.

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: NCT04122274 Completed - Concussion, Brain Clinical Trials

Comparing and Interactive Concussion Education Platform to Current Education Standards

Start date: October 21, 2019
Phase: N/A
Study type: Interventional

Purpose: The purpose of this study is to evaluate the effectiveness of a theory- driven education platform to improve concussion-related norms and perceptions in an effort to improve student-athletes concussion-related decision-making. Participants: 80 college-aged recreational athletes. Procedures: The study is a single-blind (participants) randomized control trial where participants will complete a previously validated survey assessing concussion knowledge, perceived norms, attitudes, and behavioral intentions immediately pre- and post-receipt of their designated intervention. Participants will also complete the previously validated survey two-week post receipt of their designated intervention. The interventions include an interactive concussion education platform along with the NCAA (National Collegiate Athletic Association) concussion education sheet and the NCAA concussion education sheet alone (with a sham educational intervention similar in length to the concussion education platform).

NCT ID: NCT04112914 Completed - Concussion, Brain Clinical Trials

Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department

Start date: January 5, 2021
Phase: N/A
Study type: Interventional

Investigators will conduct a hybrid implementation-effectiveness evaluation of an educational intervention that supports communication with families post-concussion in the emergency department. Primary outcomes will be parent self-report of specific concussion management behaviors two weeks post-visit. Investigators will also explore whether successful implementation is associated with (1) improved parent knowledge and self-efficacy related to helping their child adhere to CDC guidelines for returning to daily activities, school and sports, and (2) decreased disparity in knowledge and self-efficacy between high and low health literacy parents.

NCT ID: NCT04099329 Completed - Concussion, Brain Clinical Trials

One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles

Start date: August 24, 2019
Phase: N/A
Study type: Interventional

Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed to study the impact of huddles on concussion safety in youth sport, primarily regarding intention to report concussive symptoms.

NCT ID: NCT04095377 Completed - Healthy Clinical Trials

Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.

Start date: March 24, 2019
Phase:
Study type: Observational

DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.

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.