Active clinical trials for "Brain Concussion"

Sleep disturbances have been shown to contribute to poorer recovery from a concussion. Furthermore, sleep disturbances have been associated with more frequent and severe post-concussion symptoms including headache, vertigo, anxiety, depression, and decreased short term memory reducing quality of life and productivity at work or school. Additionally, recent research indicates that individuals with a concussion who have poor sleep quality have increased levels of Neurofilament light (NfL) and tau biomarkers indicating that there may still be axonal damage after weeks or months after the initial concussion injury. Post-concussion symptoms have been associated with higher levels of these biomarkers and there has been a report of higher levels of NfL and tau years following a concussion event. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia yet it remains unclear if this treatment method is effective in improving sleep outcomes, reducing concomitant post-concussion symptoms, and biomarkers of neural injury/risk in individuals post- concussion. The central hypothesis for this project is treating sleep disturbances will yield a clinically relevant reduction in concomitant post-concussion symptoms. The objective for the proposed study is to determine if CBT-I will reduce insomnia symptoms and improve concomitant post-concussion symptoms in individuals after concussion and if symptom improvements are maintained at 6-weeks and 12-weeks after CBT-I intervention.

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.

The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.

Primary Aim: Compare physiological (e.g., heart rate) and clinical responses (e.g., symptom provocation) of adolescent and adult athletes (14-35 years of age) completing either a structured treadmill running or a dynamic aerobic exertion protocol during the subacute phase of sport-related concussion recovery (3-30 days after injury). Secondary Aim: Examine potential effects of clinically-relevant factors that influence symptom responses to controlled aerobic exertion, such as age, physical activity patterns, motion sensitivities, psychological responses to injury, and sleep quality, among subjects completing controlled aerobic and dynamic exertion following sport-related concussion

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.

An exploratory open-label study of PPTH patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients who have participated in study with prior provocation (Ethics Committee of the Capital Region of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily be included. The study will begin February 2019 and is expected to last one year. Patients responding to advertisement (see add) will be contacted by phone.

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.

Introduction: Current guidelines for treating patients with mild traumatic brain injury (MTBI) recommend a period of cognitive rest and gradual return to usual activities with avoidance of any activity that exacerbates symptoms. However, recent studies have reported prolonged rest beyond 48 hours might hinder MTBI recovery, and there is limited evidence to suggest following guidelines has a positive impact on prognosis. Given the paucity of effective management strategies to prevent post-concussion syndrome (PCS) and emerging evidence of the benefits of exercise in MTBI patients, there is an urgent need for more research on the effectiveness of an early exercise intervention in the acute MTBI patient population as prevention of PCS. Research Question: Among adult (18-64 years) patients presenting to the ED with a discharge diagnosis of acute MTBI (defined by the Zurich consensus statement), does prescribing light exercise (ie: 30 min daily walking) reduce the proportion of patients with PCS at 30 days, compared to standard discharge instructions? Methods: This will be a randomized controlled trial of adult (18-64 years) patients discharged from an academic ED diagnosed with MTBI occurring within 48 hours of the index ED visit. The intervention group will receive discharge instructions prescribing 30 minutes of light exercise (ie: walking) and the control group will be instructed to gradually return to activities. Discharge instructions will be read by the attending physician or ED nurse. Patients will be provided a printed copy of the discharge instructions. Depending on their preferences, patients will be contacted by email or by telephone to complete the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), a validated, 16 item questionnaire. The primary outcome of this study will be the proportion of patients with PCS at 30 days, defined as an increase from baseline of ≥ 3 symptoms on the validated RPQ at 1 month. Secondary outcomes will include change in RPQ from baseline to 72 hours, 7 days, 14 days, 30 days post initial ED visit, number of missed days of school or work and repeat visits to a healthcare provider. To assess compliance with ED discharge instructions, patients will be asked to complete a daily activity journal and will be given fitness tracking devices.

Approximately 420 professional and amateur athletes will participate in rehabilitation during recovery after sports-related concussion. Participants will be cluster randomized, by study site, to a specific study arm. Participants will complete post-injury assessments and the intervention of their randomized group aimed at understanding the effects of a multidimensional rehabilitation protocol versus enhanced graded exertion on clinical recovery, return to play, and patient outcomes after sport related concussion

SPECIFIC AIMS While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore, post-concussive symptoms commonly co-occur with affective symptoms including depression and anxiety which when present can prolong recovery from primary post-concussive symptoms. Together, persistent physical and psychological symptoms confer protracted functional impairment and create a significant burden for affected youth, their family, and school. Currently, there are no evidence-based guidelines to inform treatment of persistent post-concussive symptoms in youth and adolescents. In response to the dearth of evidence-based treatment approaches for youth with persistent post-concussive symptoms, the investigators developed a novel collaborative care treatment model that simultaneously targets post-concussive symptoms and co-occurring depression and anxiety. Athletes and their family members receive patient navigator care management services that bridge post-injury care across acute care, specialist and primary care health service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain symptomatic after initial treatment efforts receive stepped-up care that may include psychopharmacologic consultation. The Investigators have demonstrated feasibility of the intervention model through a pilot randomized-control trial of 49 adolescents with persistent post-concussive symptoms recruited from a regional children's hospital. Participants assigned to the intervention condition demonstrated significant and clinically-meaningful reductions in post-concussive and depressive symptoms as well as health-related quality of life as compared to adolescents in the usual care arm of the trial.