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Traumatic Brain Injury clinical trials

View clinical trials related to Traumatic Brain Injury.

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NCT ID: NCT03028376 Completed - Clinical trials for Traumatic Brain INjury

Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients

PreTBI II
Start date: February 15, 2017
Phase:
Study type: Observational

The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma. Hypotheses: 1. A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients. 2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients. 3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention. 4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.

NCT ID: NCT03008434 Completed - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury and Yoga

Start date: October 2015
Phase: Phase 1
Study type: Interventional

This long-term goal of this project was to advance best practices in occupational therapy in conjunction with yoga. To address the long-term goal, this research team developed a pilot yoga intervention. The intervention was designed to focus on balance, balance confidence, body responsiveness, pain, physical ability and quality of life. Assessments were then chosen to address these areas pre and post yoga intervention. A manual and protocol were developed for the intervention and then the intervention was implemented with a group of individuals with chronic traumatic brain injury.

NCT ID: NCT03000400 Completed - Clinical trials for Traumatic Brain Injury

Family Centered Intervention After Traumatic Brain Injury

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. The intervention will be provided in collaboration with the municipal rehabilitation service. The intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by Oslo University Hospital (OUH).

NCT ID: NCT02997371 Not yet recruiting - Clinical trials for Traumatic Brain INjury

IL-1ra Dose-range Study for Moderate-to-severe TBI Patients

IL1ra
Start date: October 2017
Phase: Phase 2
Study type: Interventional

Traumatic brain injury (TBI) is a common condition with high degree of morbidity and mortality (Hyder et al., 2007). Current treatment paradigms for TBI focus on mitigating secondary injury and maintaining cerebral physiology (Carney et al., 2016), however, there are currently no approved drugs that target the underlying conditions for patients suffering from TBI (Bullock et al., 1999). It is increasingly recognised that the innate inflammatory response to TBI may inflict injury (Lucas et al., 2006), and one of the most prominent mediators of inflammation in the injured brain is the Interleukin-1 (IL-1) receptor pathway (Allan et al., 2005). An endogenous antagonist to IL-1, is available in recombinant form (IL-1ra, Kineret), and is known to be safe in TBI (Helmy et al., 2014). In order to fully understand, and potentially optimize, the effect of Kineret, the investigators wish to conduct a dose-response study by giving three cohorts (n=20 per group) either placebo (isotonic saline), 1.5g or 3.0g of active substance administered intravenously in a double-blind, randomized setting. The concentrations have in previous studies not been shown to present any side-effects (Singh et al., 2014). The drug will be provided within 12 hours after trauma. The goal will be to provide a dose-response effect on the cerebral inflammatory response. As secondary goals, the investigators will assess the brain damage by measuring proteins in blood and cerebrospinal fluid, functional outcome and inflammation in the brain using positron emission tomography.

NCT ID: NCT02993549 Recruiting - Clinical trials for Traumatic Brain INjury

TBI Multimodal Monitoring Study

monTBI
Start date: September 16, 2017
Phase:
Study type: Observational

Head injury is a common and devastating condition that can affect people at any stage of their lives. The treatment of severe head injury takes place in intensive care where interventions are designed to protect the brain from further injury and provide the best environment for recovery. A number of different monitors are used after head injury, including a monitor called microdialysis, to measure how the brain is generating energy. Abnormalities in these monitors guide doctors to the right treatments when the brain is at risk of further injury. There are lots of ways that the brain can be injured further after head injury such as raised pressure in the skull from brain swelling, low oxygen levels and low glucose levels. In this study we aim to combine information from all of these monitors to figure out what the underlying problem is and choose the right intervention to treat the problem that is affecting the patient at the time and compare this with previous treatment protocols to see if it improved outcome. Aim: To establish and validate a protocol to treat abnormalities in a microdialysis measure called lactate/pyruvate ratio (LPR) that reflects how cells are generating energy, and compare it with patient cohorts not being monitored using the current protocol.

NCT ID: NCT02990793 Recruiting - Clinical trials for Traumatic Brain Injury

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder

MeRT-005-B
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post-Traumatic Stress Disorder

NCT ID: NCT02983786 Completed - Clinical trials for Traumatic Brain Injury

Detection of Cerebral Ischemia With a Noninvasive Neurometabolic Optical Monitor

NNOM
Start date: December 2015
Phase:
Study type: Observational

The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow and metabolism monitor, by allowing physiologic and pharmacologic decisions based on real-time brain physiology, potentially will become an important tool for clinicians in their efforts to prevent additional brain tissue death in patients admitted with stroke, brain hemorrhage and traumatic brain injury.

NCT ID: NCT02980484 Terminated - Clinical trials for Major Depressive Disorder

fMRI-neuronavigated rTMS for the Treatment of Major Depression Associated With TBI

Start date: August 2016
Phase: Phase 2
Study type: Interventional

This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain injury (TBI). Half of patients will receive active treatment, while the other will receive a sham treatment with the option of receiving open-label active treatment afterwards.

NCT ID: NCT02974959 Completed - Clinical trials for Traumatic Brain Injury

Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The purpose of this single-center, prospective, randomized (1:1), double-blind, sham-controlled parallel-arm pilot study is to provide initial evidence of use of the noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and moderate traumatic brain injury to improve clinical recovery. The study compares the safety and effectiveness of an active gammaCore treatment against a sham treatment.

NCT ID: NCT02962349 Recruiting - Clinical trials for Traumatic Brain Injury

TRansfusion Strategies in Acute Brain INjured Patients

TRAIN
Start date: September 2016
Phase: N/A
Study type: Interventional

A Prospective Multicenter Randomized Interventional Study. Blood transfusion can be lifesaving in extreme circumstances, in the absence of life threatening hemorrhage, the indications for transfusion are somewhat controversial. The aim of the current study is to determine whether a"liberal" strategy of maintaining Hb concentrations above 9 g/dL would result in a different neurological outcome when compared to a "restrictive" approach to red-cell transfusion to avoid hemoglobin concentrations < 7 g/dL in critically ill anemic patients (i.e. Hb< 9 g/dL) with acute brain injury.