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Brain Injuries, Traumatic clinical trials

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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: NCT03011983 Completed - Clinical trials for Mild Traumatic Brain Injury

Neural Injury in Adolescents With Concussion

Start date: April 11, 2017
Phase:
Study type: Observational

This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain injury and to improve understanding of the biological basis of brain pathology in adolescents with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology assessments acutely and four months after injury.

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: 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: NCT02982122 Completed - Clinical trials for Brain Injuries, Traumatic

CPPopt Guided Therapy: Assessment of Target Effectiveness

COGITATE
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains 25% and only 40% of patients survive without major handicap. Medical/surgical interventions aim to maintain adequate brain perfusion, which is critically dependent on cerebral perfusion pressure (CPP); calculated as the difference between mean arterial pressure (MAP) and intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on population means. However, this 'one size fits all' approach is flawed, because the relation between CPP and brain perfusion varies between individuals. Further, this approach takes no account of autoregulation, a key protective mechanism that maintains cerebral perfusion despite CPP fluctuations. Autoregulation is variably preserved following TBI, and there are large between patient variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a certain time window. The investigators have shown that maintenance of CPP close to CPPopt is associated with improved outcomes. These data pose the hypothesis that optimisation of management in individuals may be achieved by using the zone of optimal autoregulation as a basis for defining individualised CPP targets. The investigators propose, together with collaborators in the CPPopt study group (Maastricht, Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study to develop a protocol for a definitive outcome randomized controlled trial (RCT). This study aims to develop protocols for CPPopt guided critical care, and show that they maintain patients closer to their optimum perfusion levels than standard protocols which keep above a population CPP threshold of 60 mmHg. Hence, the main objective is to offer clinicians monitoring and therapy algorithms that achieve individualized optimal CPPopt targets and potentially improve TBI outcome.

NCT ID: NCT02977728 Completed - Clinical trials for Mild Traumatic Brain Injury

Olfactory Function in Patients With Acute Mild Traumatic Brain Injury

Start date: January 2017
Phase:
Study type: Observational [Patient Registry]

In this project the investigators aim to evaluate olfactory and non-olfactory function in patients within the first 24h following a mild traumatic brain injury (acute mTBI) and compare their results to a group of age and sex matched control patients suffering from an orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year after the trauma

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: NCT02959216 Completed - Clinical trials for Mild Traumatic Brain Injury

Aerobic Exercise for Concussion

Start date: July 23, 2018
Phase: N/A
Study type: Interventional

The use of aerobic exercise treatment in the chronic phase of concussion recovery is well-described in the literature but there are limited existing data on the effect of exercise treatment in the acute phase after sport-related concussion (SRC). This study will compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold aerobic exercise versus those randomized to placebo stretching to evaluate the effect of aerobic exercise in the acute recovery phase.

NCT ID: NCT02957461 Completed - Clinical trials for Brain Injuries, Traumatic

Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes

CASVAL
Start date: February 3, 2017
Phase:
Study type: Observational

This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.