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Concussion, Brain clinical trials

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NCT ID: NCT05399849 Completed - Concussion, Brain Clinical Trials

Mindfulness Intervention in Young Adults With a Concussion History

Start date: July 25, 2022
Phase: N/A
Study type: Interventional

Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day using the LoveYourBrain Foundation Meditation Library. Before the intervention, participants will complete a baseline assessment including demographics, concussion history, mental health history, mindfulness history, perceived stress, mindfulness, and concussion symptoms. Throughout the intervention, participants will complete weekly assessments measuring adherence and concussion symptoms. After six weeks, participants will complete a final, follow-up assessment with assessments for adherence, acceptability, feasibility, intervention perceptions, perceived stress, mindfulness, and concussion symptoms. This study's aim is to determine the acceptability, feasibility, usability, and effectiveness of a mindfulness intervention in young adults with a concussion history. The investigators hypothesize that participants who participate in the mindfulness intervention will report high adherence (complete five days of meditation per week), positive acceptability, positive feasibility, and positive intervention perceptions. Additionally, after completing the intervention, participants will report decreased perceived stress, increased mindfulness, and decreased concussion symptoms compared to before the intervention.

NCT ID: NCT05379920 Completed - Concussion, Brain Clinical Trials

Salivary Biomarkers for Concussion Recovery

Start date: March 22, 2022
Phase: N/A
Study type: Interventional

The overarching purpose of this proposed research is to determine whether BDNF and/or specific miRNAs can serve as biomarkers for recovery from a concussion during prescribed exercise. The investigators hypothesize salivary BDNF and specific miRNA signatures will change in a statistically significant manner as participants proceed from injury to recovery and participants who show recovery in ANS regulation will show significant differences in salivary BDNF and specific miRNA expression. This study also aims to determine if BDNF and/or specific miRNA can serve as biomarkers of the return of ANS function in concussed patients. The basic premise here is that the volume of exercise will significantly affect the rate of change in the expression of salivary BDNF and miRNA from injury to recovery.

NCT ID: NCT05270083 Completed - Concussion, Brain Clinical Trials

Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion

Start date: July 13, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to learn if Neuraceq™ (Florbetaben F 18 Injection) PET can detect changes in the brains of young athletes who sustained one or more concussions with or without persistent cognitive complaints at least 5 years after injury.

NCT ID: NCT05142007 Completed - Clinical trials for Acquired Brain Injury

The Effect of Hypnotic Suggestion After Acquired Brain Injury or Concussion

Start date: May 11, 2017
Phase: N/A
Study type: Interventional

A recent randomized clinical trial (RCT) demonstrated large effects of hypnotic suggestion on working memory following acquired brain injury. However, no studies have investigated long-term effects (> 2 months) effects on return to work (RTW). Therefore the aim is in a RCT to study the effect of hypnotic suggestion on RTW in employed individuals with acquired brain injury or concussion, that were referred to an out-patient municipal vocational rehabilitation center in Denmark. Participants were randomized to a passive (treatment as usual), active comparison (a weekly treatment session of mindfullness-based stress reduction for four weeks) or intervention group (a weekly treatment session of targeted suggestion for four weeks). Intention-to-treat analysis of the hypnosis effect on return to work within six months follow-up will be performed. Results Participants (N=77) have accepted and participated in the study. Effect measures are to be analysed.

NCT ID: NCT05095012 Completed - Clinical trials for Mild Traumatic Brain Injury

RECOVER Clinical Pathway for Pediatric Concussion

RECOVER
Start date: September 10, 2018
Phase: N/A
Study type: Interventional

The project encompasses the development and implementation of an acute care, pediatric concussion clinical pathway at 5 pediatric emergency departments in the province of Alberta (Canada).

NCT ID: NCT05047003 Completed - Clinical trials for Mild Traumatic Brain Injury

Oculogica Portable EyeBOX Study

RESTLESS
Start date: December 19, 2020
Phase:
Study type: Observational

The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.

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: 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: 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.