View clinical trials related to Brain Concussion.
Filter by: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.
This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise)compared to a reference therapy (passive stretching) in patients who have sustained mTBI. Subjects will be randomly assigned with a ratio of 1:1 to complete either graded exercise or passive stretching using a parallel-group design. The effects of graded exercise and passive stretching will be compared using ClearPlay© (ANSwers Neuroscience Pty Ltd commercial mobile application) The study will also validate the performance of two devices: 1. ClearHeart©, ANSwers Neuroscience Pty Ltd commercial prototype for cold pressor testing, compared to ice bucket testing. 2. ClearPlay©, ANSwers Neuroscience Pty Ltd commercial prototype based on the joint position error test to assess "whiplash".
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.
Every year, approximately 2 million people in the United States and 280,000 in Canada experience a mild traumatic brain injury/concussion. In patients with concussion, symptoms experienced following injury usually get better within 3 months. However, approximately 5-25% of people will experience symptoms beyond the 3 month period, characterized by persistent headaches, fatigue, insomnia, anxiety, depression, and thinking or concentration problems, which contribute to significant functional impairment. Chronic headache is the most common symptom following concussions. They can last beyond 5 years following injury, significantly impacting daily activities. To date, post-concussion symptoms have no known "cure". One potential approach to treating post-concussion symptoms may involve using drug-free interventions, such as neuromodulation therapy. This has the goal of restoring normal brain activity. Repetitive transcranial magnetic stimulation (rTMS) is one method currently being explored as a treatment option. TMS is a procedure where brain electrical activity is influenced by a magnetic field. Numerous studies using rTMS to treat other disorders, such as dementia, stroke, cerebral palsy, addictions, depression and anxiety, have shown much promise. The primary objective of this study is to determine whether rTMS treatment can significantly improve persistent post-concussion symptoms. A secondary objective is to explore the relationship between potential changes in brain function and clinical markers associated with rTMS treatment and how functional near-infrared spectroscopy (fNIRS), a neuroimaging technology, may be used to assess rTMS-treatment response.
Background: Individuals with neurological conditions (stemming from brain injury or stroke) can experience high levels of emotional distress leading to decreased quality of life and increased health care costs. Though mental health problems are prevalent and disabling, they often go untreated for various reasons, such as access to specialized care, rural and remote location, lack of time, or concerns about stigma related to seeking care. Internet delivered cognitive behaviour therapy (ICBT) overcomes barriers to face-to-face therapy by often reaching a much wider group of patients who experience unequal access to health care. The internet based program is based on cognitive behaviour therapy, which is an evidenced-based treatment that helps patients identify and modify thoughts and behaviours that contribute to their mental health concerns. ICBT has been shown to be effective in improving psychosocial outcomes such as depression and anxiety, along with disability and quality of life among persons with chronic health conditions. Rationale: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions such as brain injury and stroke. Objective: The aim of the current study is to pilot an ICBT program developed through a patient oriented approach to improve overall wellbeing among those with mild traumatic brain injury. Methods: In this project, an ICBT program for those with mild traumatic brain injury developed through an patient oriented approach (Phase 1) will be piloted amongst a small group of participants (n=20) to examine acceptability, feasibility, and limited efficacy. At the end of the program, participants will be asked to complete a brief semi-structured interview examining barriers and facilitators to the ICBT program. Participant feedback from the interviews will be used to further improve the ICBT program to meet the needs of the population. The results from the study will be used to guide larger studies to evaluate effectiveness of the program in a community setting. Anticipated Impact: Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those who have mild traumatic brain injury and mental health concerns.
The purpose of this study is to examine the effects of concussion history and reading direction on baseline King- Devick Test (KDT) performance, a common component of sideline concussion assessments. The KDT is a timed assessment of saccades, or quick movements of the eyes between two points. This test is a form of rapid automatized naming and involved subjects reading digits arranged on a tablet screen as quickly and accurately as possible. The test has three progressively more challenging test "cards," as the horizontal guidelines between digits disappear from test card 1 to 2, and the vertical spacing between the lines of digits decreases from test card 2 to 3. KDT performance is evaluated in terms of both speed (duration to all three test cards) and the number of errors (digits read incorrectly or omitted). Previous studies have identified several factors that affect KDT performance aside from head injury, including age, sex, sleep deprivation, learning disabilities, and first languages other than English. History of concussion has not been shown to influence KDT performance. The investigators hypothesize that since the left-to-right (L-R) reading direction of the KDT is the same way in which to read English, the long-term effects of prior concussions on saccadic eye movements may be masked. The investigators want to answer the following three research questions: 1) What is the effect of KDT reading direction on baseline KDT performance? If the test is performed by reading digits in a right-to-left (R-L) direction, will KDT times be slower and the number of errors increase relative to a typical L-R KDT? 2) What is the effect of a history of multiple concussions on KDT performance relative to no history of concussion? 3) Is the R-L KDT more sensitive to a history of multiple concussions? The investigators hypothesize that individuals with a history of multiple concussions will perform significantly worse (longer test durations, more errors) than individuals with no concussion history on the R-L KDT. On the other hand, the investigators hypothesize that baseline performance on the traditional L-R KDT will not be able to discriminate individuals with a history of multiple concussions from those with no concussion history.
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.
Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.
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.
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.