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Brain Injuries clinical trials

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NCT ID: NCT04651803 Completed - Clinical trials for Traumatic Brain Injury

Outcome in Traumatic Brain Injury Elderly Patients

Start date: April 2013
Phase:
Study type: Observational

In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years). Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37% of all injury-related death in Europe. This was particularly true for patients ≥ 65 years old and in the most severe case(Glasgow coma score ≤ 8) with mortality rates between 31 to 51%. Over time, epidemiological patterns of TBI are changing. Indeed, in high-income countries, overall incidence is steadily decreasing, but increasing in elderly population with falls becoming the leading cause of TBI. In parallel, the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 (9%) million persons aged ≥65 years in the global population and that this proportion is projected to rise further to 16 % in 2050. Accordingly, we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades. In a study performed in three neuro-intensive care unit (ICUs) from 1997 to 2007, 6-month mortality in patients aged of 70-79 and ≥ 80 years was 59% and 79%, respectively. In severe elderly (≥ 65 years) TBI patients admitted in ICU, hospital and 6-month mortality was 64.6% and 72.9%, respectively. Beyond mortality, TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities, frequent use of oral anticoagulants and/or antiplatelet and/or previous brain disorders. In patients hospitalized in ICU, age (> 59 years) was the strongest parameter associated with an unfavorable outcome including death, vegetative state and severe disability, at 6 month. Moreover, TBI elderly patients (≥ 65 years) had worse functional outcome at discharge than younger patients. Identifying elderly patients who may benefit from ICU remained challenging, since there is no consensual guideline of triage. Traumatic brain-injured patients are particularly concerned by this issue. Nevertheless, few data are available related to outcome in elderly TBI patients requiring ICU.

NCT ID: NCT04646876 Completed - Clinical trials for Traumatic Brain Injury

Mgso4 as Neuroprotective in Post Traumatic Brain Injury

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the potential role of magnesium sulphate (MgSo4) as a neuroprotective agent using the Glasgow outcome scale following moderate and severe traumatic brain injury.

NCT ID: NCT04641767 Completed - Clinical trials for Mild Traumatic Brain Injury

BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

BIOTRABIS
Start date: October 28, 2020
Phase:
Study type: Observational

Traumatic brain injury (TBI) is defined as a structural alteration of brain function caused by external causes, where mild traumatic brain injury (mTBI) represents approximately 80% of all TBI, and although its prognosis is relatively good, it represents a significant cost to the system due to the need to perform a cranial computed tomography (CT) scan, a test of high economic value and not without risks such as irradiation, especially important and dangerous in the pediatric age. The investigators aim to set-up a point of-care (POC) device to validate a biomarker (H-FABP) able to diagnose the presence of brain damage in children and adults with mTBI at trauma and paediatric Emergency Departments using a blood sample, in order to save resources and avoid subjecting patients to a potentially damaging imaging test. But also, to assess whether the incorporation of new biomarkers improves the prediction of brain damage that can be done with H-FABP. For that, the investigators will recruit a 400 patients' cohort with blood samples using the available POC device for H-FABP biomarker.

NCT ID: NCT04639570 Completed - Clinical trials for Autism Spectrum Disorder

KneuroKnits: Participation and Anxiety in People With Neurological Conditions Participating in a Knitting Group

Start date: November 3, 2018
Phase: N/A
Study type: Interventional

The reported social benefits of knitting combined with the urgent need for social and activity-based programs in the disability community suggest that a knitting intervention may fill a substantial gap in available programs. Knitting may also be well suited to autistic strengths, combining sensory aspects (colourful sights, soft touch, rhythmic sounds), visual patterning, and repetitive actions. Surprisingly, no knitting programs for ASD or other conditions are reported in the literature. It is proposed that a knitting group can provide social and skill-building opportunities, improving real-world social outcomes for youth with ASD, and resulting in KneuroKnits, a program designed specifically to serve this need. The program will be designed and run by a collaborative team of clinicians, researchers, knitting experts, and a self-advocate with ASD. This program will enhance evidence supporting programs providing contexts for the dual goals of meaningful social interaction for young people with neurodevelopmental disorders, physical disabilities, and acquired brain injuries and building a real world creative skill that can facilitate social interaction within and beyond the program. This study will evaluate participants' experiences of the program as well as their levels of anxiety at various points during the program.

NCT ID: NCT04628741 Completed - Clinical trials for Traumatic Brain Injury

Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Up to 28% of undergraduate college students report a suspected history of traumatic brain injury. Following traumatic brain injury, college students fail and repeat more courses and have lower grade point averages. Further complicating this problem may be the fact that college students lack knowledge of traumatic brain injury definition, its associated symptoms, and individuals involved in post-injury management. In this project, the investigators propose to compare the use of an established treatment model (i.e., the Dynamic Coaching Model) to a novel protocol (i.e., the Apprenticeship Approach) that includes explicit instruction about traumatic brain injury in college students with this population. The investigators will use a group comparison design to examine the efficacy of this instructional component. This work incorporates findings from educational psychology and speech-language pathology (e.g., the included instructional materials adhere to the principles of adult learning). As such, this work will advance the field's basic understanding of currently recommended treatment components and will systematically examine the effects of incorporating explicit instruction into an existing treatment model.

NCT ID: NCT04614792 Completed - Clinical trials for Disorder of Consciousness

Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients

VEG-TDCS
Start date: April 30, 2014
Phase: N/A
Study type: Interventional

In response to "conscious" EEG findings related to detectable cognitive function that reliably denote awareness in vegetative state patients, in the current study, we will assess the covert conscious EEG activity (as well as standard clinical overt measures) and neuroplasctic propensity (i.e., changes in EEG spectral power synchronization values following tDCS intervention) in vegetative-state patients receiving repetitive transcranial direct current stimulation (tDCS) treatment over frontal motor areas for a period of two weeks. In support of this approach, a recent tDCS study with vegetative and minimally conscious patients implied that a twenty minutes anodal stimulation (i.e., excitatory stimulation) to the left dorsolateral prefrontal cortex (DLPFC) significantly increased CRS-R scores versus sham (placebo: non-active stimulation) stimulation condition. It was noted that this tDCS effect was more pronounced in minimally conscious state patients versus vegetative state patients excluding effects of chronicity or etiology. Thus, the investigators in this study suggested that tDCS could be effective in improving cognitive recovery in severely brain-injured patients. However, their findings would benefit neural activation correlates that could support their conclusion regarding the effectiveness of this type of non-invasive intervention in promoting neurocognitive recovery. Most importantly, tDCS is safe for use in humans, has no adverse effects, is considered the most non-invasive transcranial stimulation method because it uses extremely weak currents (0.5 to 2 mA), and, is known to only temporarily shift the neuron's membrane potential towards excitation/inhibition. In regard to the method's potential to induce functional recovery in vegetative state patients, recent clinical studies indicate that tDCS could counteract the negative effects of brain damage by influencing neurophysiological mechanisms, and is likely to contribute to the "formation of functionally meaningful connections and the maintenance of existing pathways" .

NCT ID: NCT04602806 Completed - Clinical trials for Traumatic Brain Injury

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

Start date: June 1, 2021
Phase:
Study type: Observational

This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.

NCT ID: NCT04592575 Completed - Clinical trials for Brain Injuries, Traumatic

Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients

Start date: December 15, 2020
Phase:
Study type: Observational

The purpose of this study is to determine the incidence of vestibular dysfunction in traumatic brain injury patients admitted to acute inpatient rehabilitation. This study also seeks to validate the AbilityLab Vestibular Screening Tool (AVeST) and the AVeST+, tools designed to quickly screen individuals for vestibular dysfunction following traumatic brain injury.

NCT ID: NCT04590911 Completed - Aging Clinical Trials

Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood

Start date: September 1, 2012
Phase: N/A
Study type: Interventional

In a worldwide context of accelerated demographic aging, traumatic brain injury (TBI) in older adults has become a public health problem. TBI incidence grows following an exponential curve as people get older, increasing the occurrence of TBI in ageing individuals. Rehabilitation programs used in clinical settings have generally been developed for younger adults, and their efficacy with older adults who sustain a TBI has not been evaluated. The investigators have tailored a modular cognitive rehabilitation program for individuals who sustain a TBI in older adulthood, the Cognitive Enrichment Program (CEP), by adapting approaches which have shown to be effective in normal ageing and with other neurological conditions. The aim of the study is to evaluate the effectiveness of the CEP in adults having sustained a TBI during later adulthood. Specific objectives are to evaluate the effectiveness on memory, executive functions, psychological well-being and daily life activities using psychometric tests, self-reported questionnaires, and daily life-like tasks. The investigators hypothesize that memory and executive functions training included in the CEP will result in an improvement in both psychometric and self-reported scores in a trained group of older individuals with TBI, whereas this will not be the case for a comparable TBI group who did not receive the CEP intervention.

NCT ID: NCT04584554 Completed - Clinical trials for Brain Injuries, Traumatic

Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families

R03
Start date: February 17, 2021
Phase: N/A
Study type: Interventional

Despite high risks of readmission and complex medical needs, there are no transitional care standards in the U.S. for patients with moderate-to-severe traumatic brain injury (TBI) discharged home from acute hospital care without inpatient rehabilitation. To enhance the standard of TBI care, we will develop and refine a patient- and family-centered TBI transitional care intervention that addresses specific needs and preferences for patients with TBI (age < 65 years) and families and will assess the feasibility, acceptability, and preliminary efficacy of the intervention.