Active clinical trials for "Brain Injuries"

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.

The objective of this study is to investigate the treatment effect of repetitive transcranial magnetic stimulation in patients with a history of both persistent post-traumatic headache and post-concussion symptoms. In this double-blind, sham-controlled, concealed allocation, randomized clinical trial, 20 patients aged 18-65 yrs will be recruited from the Calgary Brain Injury Program (CBIP) and the Calgary Headache Assessment and Management Program (CHAMP) / Calgary Chronic Pain Centre, Calgary, Alberta, Canada. Patients will engage in a two-week rTMS treatment protocol (10 treatments) and will be followed for 6 months after therapy.

A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.

In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. Current treatments for PTSD are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial magnetic stimulation (TMS) has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions; even showing initial promise for PTSD. We propose to study this further in a randomized sham controlled trial of TMS for PTSD.

Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. Importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. Changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. Efficacy will be assessed immediately after intervention, but also six months after the intervention. The project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.

The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Longitudinal observation allowed the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators planned to recruit 15 Veterans and non-veterans who had TBI or stroke and upper limb impairment. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.

Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the youth population, with incidences of injury steadily increasing within the past few years. Current Canadian estimates have indicated that the total rate of concussions per 100,000 increased from 467 to 754 for boys and from 209 to 441 for girls from 2003-2010. As defined by the recent Zurich Consensus statement, concussion is a pathophysiological injury induced by biomechanical forces, which can be caused by impact to the head, neck or body. In 10-20% of youth, concussion symptoms persist in the weeks, months or even years following the injury. Consequently, youth with persistent concussion symptoms are unable to fully participate in the meaningful activities (e.g. attending school, engaging with friends and community) they did prior to the injury and experience a reduced quality of life. Persistent concussion symptoms in youth requires an approach that directly addresses the rumination and attention to distressful thoughts about their functional performance, while still promoting appropriate levels of physical and cognitive demands. Targeting these constructs may shift the focus away from symptoms, while building self-efficacy and enhancing participation in daily activities. Mindfulness-based yoga (MBY) is a mind-body intervention that uses physical yoga poses, purposeful breathing techniques and a focus on being in the present moment. MBY encourages participants to develop moment-to-moment awareness of physical sensations, emotions, and thoughts, and promotes the cultivation of non-judgemental and accepting relationships to personal experiences. In chronic pain, fibromyalgia, mental health and now TBI populations, MBY has demonstrated benefits in physical (i.e. increased muscle strength, endurance), psychological (i.e. decreased stress, increased self-efficacy), cognitive (i.e. increased concentration) and social (i.e. emotional regulation, improved mood) domains. Although mindfulness based yoga has been validated as a form of rehabilitation in the adult population, its applicability for youth with persistent concussion symptoms has yet to be explored. Understanding the impact of a MBY intervention on this population may enhance management of persistent symptoms and ultimately, participation in meaningful activities. In addition to the functional sequelae that ensue following this injury, concussion in both the acute and persistent phases is being recognized as a neurophysiological injury. Traditional methods of assessment following concussion place emphasis on subjective self-report and administration of neuropsychological batteries. These assessments are used in an effort to return the youth to activity (i.e school, sport). However, these methods can be unreliable as youth have a high incentive to return to play and neurocognitive resolution does not necessarily equate to pre-injury function. To augment these measures, an objective indicator of neurophysiological stress is needed. Heart rate variability (HRV) is an objective, neurophysiological indicator of autonomic nervous system functioning. HRV is quantified by measuring the time intervals between heartbeats. Increased variability in heart rate (i.e. increased HRV) is seen as healthy neurophysiological function, demonstrating an individual's ability to adapt and be flexible to the demands of the environment. Conversely, decreased HRV is demonstrative of an individual's reduced ability to respond flexibly to their environment. Investigating the impact of persistent concussion symptoms on HRV has the potential to enhance our understanding of autonomic nervous system functioning in the chronic phases of this injury for an understudied population. The specific objectives are to: (1) adapt the MBY intervention protocol to suit the unique needs of youth with mTBI (i.e. safety, fatigue), (2) collect data on the impact of MBY on HRV, self-efficacy and participation, (3) describe changes in HRV, self-efficacy and participation associated with MBY across pre-intervention, post-intervention and 3 months following intervention, (4) identify if post concussion symptoms change (i.e. increase or decrease) following MBY and (5) identify if changes in post concussion symptoms occur with changes in HRV, self-efficacy and participation.

A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury. Patients undergoing craniotomy to treat traumatic brain injury will be enrolled. All patients will undergo standard perioperative coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count), whereas ROTEM-guided group will additionally be tested with ROTEM. "Cases" will be managed according to a ROTEM-based algorithm, and "Controls" will be treated as usual (based on clinical judging). Comparative analysis of acquired demographic, clinical and laboratory data will be performed. The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.

There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Studies in the literature examining the effect of pupillary response on mortality and outcome in pediatric patients with traumatic brain injury reported that bilaterally dilated pupils were associated with a higher mortality rate. Considering the literature results, we believe that obtaining the GCS-Pupil score by combining GCS and pupillary reaction in pediatric patients with traumatic brain injury will be effective in predicting patient outcomes.

Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can be very heterogeneous. For this reason, STELO has been developed: a new concept of exoskeleton based on modular technology for gait assistance. It allows a personalised configuration according to the functional capacity of each patient, as the therapist can choose which robotic joints to use depending on the therapeutic goal and on the patient recovery phase. The objective is to analyse the usability of the STELO modular exoskeleton in people with ABI and SCI.