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Brain Injuries clinical trials

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NCT ID: NCT06409806 Suspended - Brain Injury Clinical Trials

Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

EMBRI
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments. Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.

NCT ID: NCT04515212 Suspended - Clinical trials for Traumatic Brain Injury

In-Field Detection of Intracranial Pressure

Start date: February 3, 2021
Phase: N/A
Study type: Interventional

This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.

NCT ID: NCT04244058 Suspended - Clinical trials for Traumatic Brain Injury

Changes in Glutamatergic Neurotransmission of Severe TBI Patients

Start date: September 23, 2020
Phase: Early Phase 1
Study type: Interventional

Studies in patients with disorders of consciousness (DOC) after severe brain injury implicate dysfunction of the anterior forebrain mesocircuit dysfunction a key underlying mechanism. The anterior forebrain metabolism in DOC is markedly downregulated across brain regions underpinning highly elaborated cognitive behaviors demonstrating a collapse of the level of synaptic background activity required for consistent goal-directed behavior and arousal regulation. Since dopamine levels are one of the primary controllers of the level of synaptic background activity within these forebrain structures and in regulating excitatory glutamatergic homeostasis, the investigators propose to investigate the specific contribution of presynaptic dopamine function in glutamatergic neurotransmission in posttraumatic DOC. The aim of the present study is to measure metabotropic glutamate receptors 5 occupancy in the main gutamatergic structures of the brain using (3-[18F]fluoro-5-(2-pyridinylethynyl)benzonitrile)-positron emission tomography ( [18F]FPEB-PET) at rest and following a short pharmacological challenge with amantadine, an N-methyl-D-aspartate receptor (NMDA-R) antagonist, following L-DOPA, and amantadine + L-DOPA. Using this novel technique in DOC the investigators will characterize the relevance of a presynaptic deficiency to synthesize and/or release dopamine in the final regulation of excitatory interneurons of the anterior forebrain mesocircuit. It is unknown whether glutamatergic neurotransmission is affected across the population of subjects with DOC and, if this condition is secondary to a presynaptic dopaminergic failure of the anterior forebrain mesocircuit (i.e., down-regulation). Since the investigators previously identified the existence of a presynaptic dopaminergic deficit in these subjects due to a failure in the biosynthesis of dopamine, the investigators will evaluate if by providing the main biological substrate of the biosynthesis process (i.e., L-DOPA) the glutamatergic system regains homeostasis. The investigators therefore propose to investigate patients with posttraumatic DOC using [18F]FPEB-PET at rest and following short pharmacological challenges aimed at increasing glutamate and dopamine release.

NCT ID: NCT04070092 Suspended - Clinical trials for Traumatic Brain Injury

The Impact of Traumatic Brain Injury in the Elderly

Start date: July 29, 2019
Phase:
Study type: Observational [Patient Registry]

A better understanding of the impact of Traumatic Brain Injury (TBI) in the elderly, in terms of brain damage, cognitive and motor functions, sleep quality and quality of life is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the short-term consequences of TBI by studying injury patterns, injury severity, risk profiles, brain damage, co-morbidities, post-traumatic history, level of dependency, serum-based injury biomarkers, cognitive and motor functions, sleep quality and quality of life 6 months after TBI. All the obtained results will be integrated in a new prognostic tool for the course of the outcomes of TBI in the elderly population.

NCT ID: NCT03249220 Suspended - Brain Injuries Clinical Trials

Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients

CBMS FIH
Start date: January 18, 2018
Phase: N/A
Study type: Interventional

Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.

NCT ID: NCT02773888 Suspended - Stroke Clinical Trials

An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

Start date: December 2015
Phase: N/A
Study type: Interventional

Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

NCT ID: NCT02174016 Suspended - Clinical trials for Acute Brain Injuries

The Ketogenic Diet for Pediatric Acute Brain Injury

Start date: January 2015
Phase: N/A
Study type: Interventional

This is a prospective pilot study evaluating the safety and feasibility of implementing the ketogenic diet in children admitted to the pediatric intensive care unit with acute brain injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in clinical practice for the treatment of medication resistant epilepsy and is intended to switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be detectable through serum tests and MRI spectroscopy studies of the brain within several days of diet initiation, and that there will be a low incidence of side effects and adverse events, Measures of interest will include the incidence of kidney stones, excessive acidosis and excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies within the brain will be measured through MRI spectroscopy sequence which will be acquired at the same time as a follow-up MRI brain study ordered for clinical purposes.

NCT ID: NCT01571375 Suspended - Clinical trials for Traumatic Brain Injury

The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury - a Prospective Study

Start date: June 2012
Phase:
Study type: Observational

The Aim of the Study is to Measure the Effect of Finnish Physician-staffed EMS Unit Treatment Methods on Traumatic Brain Injury (TBI) Patient Prognosis. Physician-staffed HEMS unit was implemented to the EMS 2011. The aim of this study is to compare the results against a historical database to see if the implementation of a HEMS unit will improve the prognosis of TBI patients.

NCT ID: NCT01132898 Suspended - Clinical trials for Traumatic Brain Injury

Long-term Clinical Correlates of Traumatic Brain Injury

Start date: March 31, 2011
Phase:
Study type: Observational

Background: - Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury. Objectives: - To study the natural history of traumatic brain injury by examining the changes in brain scans, blood samples, and brain function over 5 years after injury. Eligibility: - Individuals 18 years of age and older who have had a traumatic brain injury within the past 1 year. Design: - This study will include about eight visits to the NIH Clinical Center over 5 years. Participants will have four visits in the first year, and one visit each year for the following 4 years. Each visit will take between 1 and 4 days, and participants will be in the outpatient clinic for about 8 hours each day of the visit. - At each study visit, participants will have some or all of the following tests: - Medical history and physical examination - Blood and urine tests - Questionnaires and assessments of thinking and memory, which may be spoken aloud, written down, or entered into a computer - Imaging scans, such as magnetic resonance imaging (MRI) or positron emission tomography/computed tomography (PET/CT). - This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

NCT ID: NCT00761228 Suspended - Brain Injury Clinical Trials

Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury

NH001-2
Start date: July 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.