Active clinical trials for "Brain Injuries"

The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center. Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.

This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.

The purpose of this two phase study is to evaluate comprehension by people with acquired brain injury. The phase 1 portion of the study will examine comprehension of narrative paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David voice) or combined written text and auditory output. The phase 2 portion of the study is to evaluate comprehension of sentences and paragraphs produced with computer generated (synthesized) speech and digitized natural speech after multiple exposures.

An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. This study is an interventional, two-arm, 6-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The 6-9 month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at 6-month follow-up. Moreover, a budget impact analysis and possibly a cost utility analysis of the intervention will be performed The program is one of the first to include a comprehensive and target VR intervention including multiple parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI. The first hypothesis of the study is that more participants allocated to the VR intervention group will have a significant higher employment/study rate (measured in hours) at 6-month follow-up when compared to participants receiving the conventional VR program provided by the municipalities (control group). The second hypothesis is that health-related quality of life (HRQoL) and disability among the participants as well as the HRQoL and caregiver burden among the caregivers are significantly improved at the end of the VR intervention and at 6-month follow-up when compared to the conventional VR program. Finally, a budget impact and possibly a cost utility analysis will be performed.

The study includes people who have recently had a traumatic brain injury (TBI) and healthy controls who have not had a TBI and is designed to measure brain blood flow serially after a TBI. Studies have shown that small blood vessels in the brain may be injured during a TBI. The goal is to learn about brain blood vessel function from as early as the first week to 6 months after a TBI . The study uses Near Infrared Spectroscopy (NIRS) which uses small lights that detect oxygen levels in the blood, measuring blood flow in the brain. This is compared with magnetic resonance imaging (MRI). When blood flow increases in the brain in response to a stimulus, this is called cerebral vascular reactivity (CVR). The study aims to learn about CVR using a few minutes of special breathing similar to breath holding while in an MRI (magnetic resonance imaging), and CVR measures after one dose of a common drug called sildenafil (generic Viagra) 50 mg taken once during CVR measurements at each of up to 4 visits. The investigators will measure CVR at different times during a 6-month period in participants who have had a TBI to see how CVR measures and blood vessels function during the first 6 months after a brain injury.

There is a lack of evidence about the best method to involve the patient and population (IPP) into clinical practice guidelines (CPG) development. The goal of this pilot study is to document the acceptability, feasibility and effectiveness of two methods for the implication of patients with a traumatic brain injury (TBI) in CPG development. Method: A single blind, randomized crossover trial will be performed with patients having a TBI. Participants: A convenience sample of 20 patients a) with a moderate-to-severe TBI (Glascow Coma Scale <13), b) living with a TBI for two to four years, c) French-speaking, d) able to use a computer and e) able to participate in a two-hour group meeting will be recruited among the members of the Associations TCC Des Deux Rives. Procedures: The patients will first receive a in-person training on guidelines and IPP. They will be randomized into Group 1 or Group 2 by a researcher blinded to experimentation. They will experiment either group discussion (control intervention) or a Wiki (experimental intervention). Phase 1: A week after the training, Group 1 participants will be invited to a discussion group animated by an experimented moderator, where they will be asked to discuss a CPG recommendation chosen by the research team in an existing CPG. The participants will be asked : 1) about their opinion of the recommendation; 2) if they have a preference in regard to the recommendation ; 3) if they have some modification, correction or addition to bring to this recommendation. In the mean time, Group 2 participants will receive an email presenting a link to a Wiki. They will be invited to answer the same three questions as Group 1, but using a Wiki platform. The patients will have a week to interact and answer the questions; recalls could be sent by email if required. At the end of Phase 1, participants of both groups will fill a questionnaire documenting the acceptability of the method experimented. Phase 2: As per the crossover design, the Group 1 participants will then be assigned to the Wiki intervention and the Group 2 participants will be assigned to the discussion group intervention. The procedure will be repeated with a second recommendation. At the end of Phase 2, the patients will be asked to answer a short survey to validate their preferences about the two methods. Tools: The acceptability of the methods will be evaluated with a questionnaire adapted from Sidani and al. and validated with three TBI individuals. The feasibility of the intervention will be evaluated using a) the number of participants who reached the group or the Wiki, b) the number of participants who completed the intervention c) the number of support interventions required in the group and in the Wiki. The effectiveness of the two methods will be evaluated by submitting the adapted recommendations to a panel of expert clinicians evaluators blinded to the methodologies of recommendations adaptation. They will be invited to rate the clarity, accuracy, appropriateness and usefulness of the recommendations. Analysis: Feasibility indicators will be reported using descriptive statistics. Within-subject analysis using non-parametric statistics will be performed to assess the acceptability of the two methods. AC1 coefficient of raters' agreement will be calculated on the expert evaluation scores, and the effectiveness of the methods will be compared using appropriate non parametric statistics to. Impact: This pilot trial will be the first one to evaluate methodologies for involving disabled individuals into CPG development.

Studies have shown that a period of sleep, even in the form of a daytime nap, after a period of training on a motor learning task can boost subsequent performance beyond that observed after an equal amount of time spent awake and resting. This leap in performance has been referred to as "off-line" motor learning because it occurs during a period of sleep in the absence of additional practice. Motor learning is an integral part of the physical and occupational therapy that patients receive after traumatic brain injury (TBI) in which various activities of daily living may need to be relearned. Targeted motor skills may include dressing (learning how to zip up a jacket or button a shirt), using a fork and knife to eat, or using technology (tapping touch screen on a cell phone or typing on a computer). Yet the potential of sleep in the form of a strategic nap as a therapeutic tool to maximize motor learning in rehabilitation therapies has not been fully realized. In addition, a growing body of research among healthy individuals has shown evidence of changes in the brain associated with enhanced performance among those who slept following training compared with those who spent the same amount of time awake. The neural mechanisms of "off-line" motor learning have not been studied among individuals with TBI. Using functional neuroimaging and measurement of brain waves, the current study will examine the mechanisms underlying this sleep-related enhancement of motor learning among individuals with TBI and determine how brain physiology may influence the magnitude of the effect. By understanding how this treatment works and identifying the factors that modulate its effectiveness we can identify which individuals will be most likely to benefit from a nap after training to improve motor learning after TBI. This can provide a more person-centered approach to treatment delivery that can maximize the effectiveness of a simple but potent behavioral intervention.

Working memory is a limited capacity cognitive system in which information is held temporarily in order to make it available for processing. The amount of information that can be held in mind varies considerably from person to person and changes across the lifespan. Working memory is frequently affected following brain injury. As working memory is important for cognitive skills such as problem solving, planning and active listening, a deficit in working memory can lead to difficulties with many everyday activities that are necessary for work, study and general functioning. Impaired working memory may consequently have a significant impact on a person's quality of life and ability to participate in previous social roles, with potential for effects on mood and emotional wellbeing. Evidence shows that non-invasive transcranial direct current brain stimulation (tDCS) can be used in combination with computerized memory training (CT) over multiple days, to enhance working memory in healthy and clinical populations. In patients with an acquired brain injury (ABI), cognitive training or brain stimulation have been used alone to improve attention or memory-related impairment, but the effect of the concurrent used of the two interventions over multiple days is yet to be investigated. With this research the investigators propose to investigate the effect of the combined use of tDCS and CT to improve memory performance in patients with acquired brain injury. The investigators propose to use a multi-day cognitive training regime to exercise working memory, while stimulating the brain with low intensity direct currents. Success will be measured as improvement in performance in several cognitive domain, before and after training.

The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral symptoms?

This research project aims to find out if a multiplayer online video game can provide therapeutic benefit for people who have survived a brain injury. Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008). These positive emotional effects may enhance cognitive rehabilitation, because the cognitive and emotional sides of rehabilitation are connected (Mateer, 2005). The hypothesis is thus: that playing multiplayer online games can be a useful form of cognitive rehabilitation for brain-injured people. This research will identify whether or not multi-player online video games may be used as a complementary therapeutic tool. A further aim is to develop guidelines which would help others considering the use of video games for cognitive rehabilitation.