Active clinical trials for "Brain Injuries"

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

The proposed study tests the feasibility (Phase I) of PATH neurotraining to improve working memory and attention in mTBI patients rapidly and effectively to provide clinical testing of a therapeutic training for the remediation of cognitive disorders caused by a concussion. This study will contribute to the fundamental knowledge of how to remediate concussions from a mTBI to enhance the health, lengthen the life and reduce the disabilities that result from a mTBI.

Methylation of the brain-derived neurotrophic factor (BDNF) gene is involved in both the biological encoding of childhood adversity and neuroplasticity following traumatic brain injury (TBI). This research will characterize BDNF methylation during recovery from TBI in children and investigate this novel biomarker as a potential biological mechanism underlying the known association between childhood adversity and poorer neurobehavioral outcomes following TBI in childhood. Findings from this research will contribute to an improved understanding of why some children display good recovery following TBI, whereas many others suffer from chronic neurobehavioral impairments.

The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

Pediatric traumatic brain injury (TBI) is often associated with difficulties in social functioning. Loss of social contacts and difficulties maintaining social connections is common after pediatric TBI, extending into adulthood. Social skills are a key aspect of social functioning critical to forming and maintaining social relationships with others, including family, friends, teachers and co-workers. Social skills deficits are thus critical to social participation and overall quality of life. The identification of treatment techniques to effectively address these issues are thus of paramount importance. The ability to improve social skills in adolescents and young adults is critical as they transition from school settings into the workforce. Impairments in social skills have been demonstrated to underlie difficulties transitioning from school to work and independent living in students with disabilities. Therefore, targeting social skills interventions as individuals enter adulthood and enter the workforce is likely to improve overall functioning during this transitional period in their lives. The current study will examine preliminary efficacy of a manualized group intervention that targets social skills, specifically work-related social skills known as soft skills. Targeting not only general social skills, but soft skills in particular, is expected to be particularly useful for teens and young adults as they transition from school into the workforce. The Assistive Soft Skills and Employment Training (ASSET) is a 15-session training program that combines specific skill training, structured learning, social performance training and a social hour to practice skills through a manualized group intervention. Specific skills taught within the program include communication, attitude and enthusiasm, teamwork, networking, problem-solving and critical thinking, professionalism, mental health and stress management, awareness of self and others, workplace relationships and self-advocacy. ASSET utilizes a manualized curriculum and provides additional support including handouts, PowerPoint summaries, instructional procedures, video models, materials for caregivers, and an online platform to support learning the program. ASSET has been utilized with young adults with ASD with very positive results, improving performance on measures of social skills, social communication, self-confidence/self-efficacy and psychological wellness. The current proposal will test the efficacy of the ASSET program in youth and young adults with TBI between the ages of 15 and 25, a critical time as individuals' transition from school settings into the workforce. The proposal will evaluate the primary outcome of improvements in social skills following completion of the ASSET program. Secondary outcomes of self-efficacy, depression, anxiety and quality of life will also be evaluated following completion of the program.

The goal of this clinical trial is to test a new type of magnetic brain stimulation in patients with persistent post-concussive symptoms. Participants will undergo detailed MRI scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the study aims to answer are: Will this new type of treatment result in fewer symptoms and better daily functioning? What are the effects of this treatment on brain functioning?

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift <5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.

Theoretical Framework & Background Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions. Hypotheses Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue. Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue. The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome. Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status. Methods Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach. Level of originality Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.

An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data_Standards.

Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with TBI, disrupting return to work, communication re integration, socialization, and quality of life. The few prior attempts to treat discourse impairments have been small case studies and resulted in no change or limited gains. The proposed study evaluates the feasibility of a novel narrative discourse treatment that builds upon these prior attempts by addressing breakdowns in both story content and story organization using a theoretically-driven approach. If feasible, as demonstrated by tolerability and acceptability to participants, and later shown to be effective, the proposed discourse treatment has the potential to improve daily communication, which provides a gateway for Veterans with TBI to increase meaningful participation and improve functioning in major life domains.