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Traumatic Brain Injury clinical trials

View clinical trials related to Traumatic Brain Injury.

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NCT ID: NCT03307070 Completed - Clinical trials for Major Depressive Disorder

Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury

Start date: September 23, 2017
Phase: N/A
Study type: Interventional

Cognitive behavioral therapy for major depressive disorder (MDD) was adapted for individuals with moderate to severe traumatic brain injury (TBI) (CBT-TBI). A structured, treatment manual was developed. The primary aim is to evaluate the acceptability and tolerability of, and adherence to, CBT-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40). The exploratory aim is to evaluate the potential efficacy of CBT-TBI for MDD in the randomized pilot trial (N=40) and possible moderators and mediators of outcome.

NCT ID: NCT03306563 Completed - Clinical trials for Traumatic Brain Injury

Rapid Biochemical Diagnostics of Traumatic Brain Injury

Start date: December 28, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.

NCT ID: NCT03304899 Recruiting - Clinical trials for Traumatic Brain Injury

Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Start date: October 23, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death. The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.

NCT ID: NCT03296293 Completed - Clinical trials for Traumatic Brain Injury

Effects of Positive End-expiratory Pressure on Intracranial Pressure in Patients With Severe Traumatic Brain Injury

PEEP,ICP,CVP
Start date: August 1, 2016
Phase: N/A
Study type: Interventional

The impact of PEEP on ICP was dependent on the difference between elevated CVP levels and baseline ICP levels. ICP would increase once elevated CVP through PEEP adjustment exceeds the baseline ICP.

NCT ID: NCT03287557 Completed - Clinical trials for Traumatic Brain Injury

Dysregulated CNS Inflammation After Acute Brain Injury

Start date: January 2, 2018
Phase:
Study type: Observational

By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.

NCT ID: NCT03281759 Recruiting - Clinical trials for Traumatic Brain Injury

Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

LED-TBI
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.

NCT ID: NCT03280485 Recruiting - Clinical trials for Traumatic Brain Injury

Validation of the Scandinavian Guidelines for Management of TBI in Adults

Start date: September 10, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Traumatic brain injuries (TBI) are one of the most common reasons for patients to attend the emergency department (ED). 90% of patients with TBI are defined as mild TBI (mTBI). A small minority of patients with mTBI would show pathological computed tomography (CT) results and even fewer need neurosurgical intervention. Nevertheless, complications would be so severe, if neurosurgical intervention is delayed, that it has become common practice to subject all patients with mTBI to CT. The high number of CT scans has an impact on health care resources but may also involve risk by subjecting patients through potentially harmful ionizing radiation. Several independent research groups have attempted to optimize CT use in mTBI patients by forming guidelines that aim to identify patients at high risk for intracranial complications. Most guidelines have been published in the past 15 years and have been validated both prospectively internally and externally; all guidelines have been shown to be safe when implemented in clinical use with few missed complications. However the number of CT scans has not been reduced dramatically, in some cases it has even increased. In 2013, the new Scandinavian guidelines (SNC13) were published. They are the first guidelines that use a biomarker, S100B, as a tool for managing patients with mTBI. Although S100B has a low specificity for intracranial complications, a high sensitivity makes it suitable to be implemented into clinical practice as a tool for CT reduction. Previous SNC guidelines have been compared to other prominent guidelines with impressive results. The SNC13 have been externally validated in a retrospective study from the USA that was underpowered for important outcomes. Nevertheless, SNC13 have already been partially implemented in clinical practice in Scandinavia. However, a strict multicenter validation has not been performed yet nor a systematic comparison to other available guidelines. Our primary aim is to validate the performance of the SNC13 in predicting intracranial complications in adult patients presenting with traumatic head injury in Swedish hospitals. A secondary aim is to compare the performance of SNC 13 with 6 other clinical guidelines, with respect to important outcomes. Moreover, to explore the performances of different biomarkers in predicting intracranial complications in predefined subgroups of TBI. Finally, to evaluate the possibility of further improvement of the SNC13.

NCT ID: NCT03277859 Completed - Clinical trials for Traumatic Brain Injury

Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)

SAA-TBI
Start date: August 16, 2017
Phase: N/A
Study type: Interventional

The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.

NCT ID: NCT03268304 Withdrawn - Stroke Clinical Trials

Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments

Start date: November 1, 2018
Phase:
Study type: Observational

Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process. Objectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients & methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L). Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training.

NCT ID: NCT03261674 Completed - Clinical trials for Traumatic Brain Injury

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Start date: June 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).