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Brain Injuries, Traumatic clinical trials

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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: NCT04642443 Recruiting - Clinical trials for Traumatic Brain Injury

Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage

Start date: December 23, 2020
Phase: N/A
Study type: Interventional

This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the detection and monitoring of intracranial hemorrhages.

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: 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: NCT04624152 Completed - Trauma, Brain Clinical Trials

The Role of Hypoxia on Subconcussive Head Impacts

Start date: October 22, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the combined effects of hypoxia and a short bout of subconcussive head impacts on neurocognitive and ocular-motor function and plasma expression of brain-derived blood biomarkers.

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: NCT04610697 Recruiting - Depression Clinical Trials

Cognitive Remediation in Forensic Mental Health Care

CRFMHC
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

NCT ID: NCT04603443 Recruiting - Clinical trials for Traumatic Brain Injury

SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI

SmART-TBI
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementation with branched chain amino acids (BCAA), based on the study team's previous preclinical work showing restoration of glutamate neurotransmitter balance in sleep and memory circuits. Supplementation with Amino acid Rehabilitative Therapy in TBI (SmART-TBI) is a randomized, placebo-controlled, double-blinded, exploratory clinical trial of BCAA intended to establish the feasibility, acceptability, and limited efficacy of long-term BCAA to improve sleep and cognition in Veterans with mTBI. These results will inform the optimal study design of a future, full-scale randomized controlled trial, including the identification of the proper dose and duration of BCAA to improve sleep and the potential subpopulations of Veterans with mTBI that may benefit the most.

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: NCT04597879 Recruiting - Trauma Clinical Trials

Impact of Severe Brain Injury on Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.

MicroTC
Start date: August 1, 2021
Phase:
Study type: Observational

Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults, but its peripheral vascular consequences in humans are poorly understood. This prospective, monocentric, pathophysiological study aims to investigate differences in vasoreactivity in the anterior aspect of the contralateral forearm at the most injured cerebral hemisphere between patients with severe head trauma and patients with severe trauma without associated brain injury matched on sex and age (+/- 5 years).