Active clinical trials for "Brain Injuries"

The long-term objective initiated with this study is to determine which brain areas functionally contribute to learning a motor skill. The primary hypothesis of this trial is that premotor cortex (PMC) is necessary to learn a new motor skill. Participants may undergo a MRI scan to acquire a structural image of their brain to target noninvasive stimulation, using transcranial magnetic stimulation (TMS) to one of two brain areas: PMC or primary motor cortex (M1). A third group of individuals will undergo a placebo stimulation protocol. For all three groups, stimulation will be used to create a transient 'virtual lesion' during motor skill training. Temporarily disrupting the normal activity of these brain regions during training will allow us to determine which regions are causally involved in learning a new motor skill. The primary outcome measure will be the change in skill after training in each group.

Traumatic brain injury (TBI) is the most common type of nerve injury and it severely endangers the public health. It is necessary to accurately measure the early neurological function of brain injury for monitoring its prognosis and therapeutic interventions. Glasgow Coma Score (GCS) and Computed Tomography (CT) are often used to diagnose the severity of TBI. However, GCS has its drawbacks in the observation of prognosis, because it is interfered by analgesics, sedatives and relaxants in the evaluation of neurological function. CT may miss the diagnosis of diffuse axonal injury (DAI) and the monitoring of intracranial pressure (ICP). Secondary injuries after TBI, such as oxidative stress, inflammatory damage, and abnormal metabolism, can destroy cerebral blood vessels and structures, which also affect the diagnosis of injury. Therefore, there is an urgent need for new methods to quickly identify which patients are likely to suffer brain injury or even cause persistent disability. Detection of brain injury biomarkers based on blood and brain tissue has long been used to assess the severity of TBI, but no biomarkers have been found for early diagnosis of mTBI and prognosis of different degrees of brain injury. Protein and metabolic product differences were detected from blood or the lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform, and diagnostic markers of potential traumatic brain injury were found, and their differential and diagnostic values were discussed.

The purpose of the present study is to follow unpaid caregivers of ABI survivors in Nova Scotia over time to learn more about their experiences. The study is funded by the Government of Nova Scotia (i.e. Department of Health and Wellness). The present longitudinal cohort study will help increase knowledge about ABI caregivers at a provincial level. Findings will also be used in developing future interventions to help caregivers in this population. The goals of the research study are: To understand the natural experiences of unpaid caregivers over time. More specifically, the investigators hope to learn about the experiences of unpaid caregivers of acquired brain injury survivors in Nova Scotia. To examine the connection between study demographic variables (e.g. the amount of time spent caregiving in hours per week), and psychological outcome variables (e.g. caregiver burden). To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring). To provide a platform for future studies using the Trials within Cohort (TwiC) study design.

More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.

A non-randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.

Normal pressure hydrocephalus (NPH) is a neurodegenerative disease of unclear etiology characterized by a clinical trias named after the neurosurgeon Hakim. It includes cognitive impairment (dementia), gait disturbance, and urinary incontinence. These symptoms, which frequently occur in the elderly population, often overlap with the symptoms of "other" neurodegenerative diseases, especially Alzheimer's disease and other (pre)senile dementias. To distinguishing NPH from "other" dementias is crucial in determining whether a patient will benefit from a surgical procedure (ventriculoperitoneal shunt placement) or not. At the same time, the options for assessing the patient's condition's progression and distinguishing between the progression of neurodegeneration in a broader sense or malfunction of the drainage system are very limited. Therefore, the role of a biomarker that could meet these expectations mentioned above is highly desirable.

Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ameliorate the consequences of TBI. Sildenafil potentiates nitric oxide (NO) dependent vasodilatation and is approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction and primary pulmonary hypertension. In pre-clinical models of stroke, sildenafil improves cerebral blood flow (CBF), promotes, angiogenesis, neurogenesis and improves recovery. In an initial Phase 2a trial (NCT01762475) of sildenafil in patients with chronic moderate to severe TBI, the investigators found that low dose sildenafil (25 mg BID) therapy is safe and well tolerated, that a single dose of sildenafil 50 mg potentiates CVR in areas of the brain with dysfunctional endothelium, and that CVR is a reliable diagnostic marker of TCVI and has potential as a pharmacodynamic and predictive biomarker. In this proposal, the investigators will conduct a randomized clinical trial to determine the optimal PDE5 inhibitor dose to improve or normalize microvascular function (as measured by the change in CVR measurements before and after a single dose of sildenafil, or ΔCVR) using a range of sildenafil citrate doses: 20, 40, 80 mg) in chronic TBI patients. The investigators will also test the safety and tolerability of the same dose ranges of chronic (4-week) thrice daily sildenafil or placebo administration in chronic TBI patients and explore its effects on chronic symptoms and clinical outcomes.

This study first aims to validate the feasibility of a multimodal 5-day 20-minute tACS protocol in subacute brain-injured patients with a disorder of consciousness during their ICU stay, and conduct a clinical pilot study (validation phase). Upon completion of this validation phase and according to obtained results, a randomized clinical trial will be conducted to compare the effects of the 5-day active 10Hz-tACS protocol with a 5-day sham-tACS protocol on brain dynamics modulation. This study will also compare intervention conditions on recovery of consciousness, cognition and function using short-term and long-term measurements.

The purpose of this study, is to investigate whether creatine monohydrate as a supplement reduces the number and severity of symptoms in patients with persistent post-concussive symptoms through self-reported post-concussion symptoms questionnaires.

Traumatic brain injury (TBI) is a common cause of long-term neurological morbidity, with devastating personal and societal consequences. At present, no pharmacological intervention clearly improves outcomes, and therefore a compelling unmet clinical need remains. 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or "statins," offer a potential novel therapeutic strategy for TBI. In this study the investigators will study primarily the effect of statins on 30-day mortality rate which is defined as death within 30 days of TBI presentation where the occurrence of TBI is hour 0 or day 0 and secondarily evaluation of duration of ICU stay associated with or without complications.