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Coma clinical trials

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NCT ID: NCT02901262 Completed - Clinical trials for Traumatic Brain Injury

Continuous Quantified EEG in NeuroIntensive Care

CrazyEEG
Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.

NCT ID: NCT02798588 Completed - Coma Clinical Trials

Improving Awakening Prognostication After Non Anoxic Coma Using PET-MRI in Intensive Care Unit

ETIC
Start date: February 16, 2017
Phase: N/A
Study type: Interventional

In last decades, several advances in the neuro-intensive management have lead to decrease mortality in Intensive Care Units. A significant morbidity remains as patients survive after a traumatic coma with uncertain quality of awakening and a high risk of functional disability. Predicting awareness recovery and functional disability of those who will awake constitutes a major challenge to inform patients' relatives, to give the best chances in terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools currently available are not sufficient neither to predict bad awakening outcome nor to predict good functional outcome. In many countries, life's support cessation is a constant call for robust evaluation as soon as possible in ICU but it is mandatory to reach a positive predictive value of non-awaking close to 100%. Many clinical, electro-physiological, biological, radiological and functional parameters have been conducted with comatose patients assuming the purpose to predict outcome. Regarding unfavourable outcome, the gold standard is the abolition of the N20 component of somatosensory evoked potentials but the specificity is high enough only for patients with anoxic coma. Several neurophysiological markers such as MMN, P300 are correlated to a favourable outcome but the sensitivity and specificity remains low for patients who suffered a severe traumatic brain injury. New Diffusion Tensor imaging sequences provide complementary information to detect small structural lesions (diffuse axonal lesions). Recently, functional MRI analyzing Resting State has also been proposed as a prognostic marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the metabolism in key regions of the awakening network in either anaesthesia or sleep. Recent studies have reported interesting results at the chronic stage but to knowledge, these tools have only been used to address pathophysiology's issues and never to improve coma prognosis at the initial stage. The investigators hypothesize that the heterogeneity of the population requires a global and accurate assessment of the central nervous system, combining structural, metabolic and functional information in order to refine the prognosis. The protocol integrates in one-sequence most radiological markers of brain injury within a unique PET-MRI in Lyon. The most relevant originality of the study consists in confronting FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery. The added clinical value would be to question the synergistic effect of each parameter and to find out which ones are the most useful for awakening prediction, as they have not been compared in a multi-parametric database. PET-MRI, as a new device combining physiological and prognostic questioning, allows us: - to implement a more integrative physio-pathological analysis - to avoid the cofounding effect of awareness' fluctuations in recording simultaneously multiple functional imaging techniques. The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity, related to neuronal activity (glucose metabolism) and brain perfusion.

NCT ID: NCT02742506 Completed - Coma Clinical Trials

Beneficial Effects of Music on Cognition and Consciousness Level

MUSICOREVEIL
Start date: June 25, 2013
Phase: N/A
Study type: Interventional

Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged patients. However, it is still difficult to understand what precisely in music causes a positive effect : are they emotional components, familiarity or preference which improve cognition or is there any specific effect of music? Moreover, it is not yet possible to characterize the neural and functional links between the brain systems solicited by music and those associated with other cognitive functions enhanced by music. Finally, researches on brain-damaged patients have not exploited the potential effect of music on the level of alert and perceptual awareness, while this type of stimulation could be a valuable tool to improve cognition in patients with a disturbance of consciousness and alertness. The main objective is to describe the impact of music on the brain's response to self-referential or neutral stimuli in brain-damaged patients with persistent consciousness disorder after a coma and in healthy participants.

NCT ID: NCT02588482 Terminated - Post Anoxic Coma Clinical Trials

Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients

COMETIQUE
Start date: June 17, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients

NCT ID: NCT02566720 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

Start date: January 2016
Phase: N/A
Study type: Interventional

This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.

NCT ID: NCT02486211 Completed - Heart Arrest Clinical Trials

Amantadine to Speed Awakening After Cardiac Arrest

AWAKE
Start date: September 2015
Phase: Phase 2
Study type: Interventional

This study evaluates if amantadine will increase the rate of awakening in patients resuscitated from cardiac arrest but comatose (not following commands) after their resuscitation. Half of the participants will receive amantadine and the other will receive placebo.

NCT ID: NCT02442791 Completed - Cardiac Arrest Clinical Trials

GLP-1 Analogs for Neuroprotection After Cardiac Arrest

GLIP1
Start date: June 2014
Phase: N/A
Study type: Interventional

Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1 analogs in various degenerative neurological diseases, and in hypoxic brain injuries in experimental designs. This study is designed as a safety and feasibility study with patients randomized 1:1 to receive GLP-1 analogs immediately after hospital admission after out of hospital cardiac arrest.

NCT ID: NCT02427633 Completed - Coma Clinical Trials

Study of Body Positions in Unconsciousness

Start date: August 23, 2014
Phase: N/A
Study type: Interventional

In resource limited settings, access to one-on-one nursing care and airway protection by intubation may be unavailable. Patients with coma but adequate oxygenation are frequently cared for on medical wards, and nursed by their family members. The investigators previously audited the use of the recovery position in patients with cerebral malaria and found that its usage was greatly increased by an educational intervention aimed at patient's caregivers. A trend to reduction in coma duration and aspiration pneumonia was also found. Since there is no evidence that placing comatose, non-intubated patients in a recovery position improves outcome, the investigators plan to conduct a randomised controlled study comparing standard care with an educational intervention targeting patients' relatives, teaching them to maintain their relative in one of two different recovery positions. With the preliminary efficacy and safety data and feedback that this study will provide, the investigators would then move to conduct a large multicenter study powered to detect a difference in mortality.

NCT ID: NCT02338284 Recruiting - Coma Clinical Trials

Optic Nerve Sheath Diameter as a Screening Test for Increased Intracranial Pressure

Start date: October 2014
Phase: N/A
Study type: Observational

Patients admitted to the ICU may have delayed awakening after their critical illness has resolved. Though most either are due to metabolic causes or delayed elimination of sedative medications, more serious pathologies such as intracranial hemorrhage, ischemic stroke, and vasogenic edema may also be the cause of coma. These pathologies all result in increases in intracranial pressure (ICP) with cerebral edema. Identifying elevated intracranial pressure elevations have so far, relied on invasive monitoring techniques requiring placement of an intracranial or intraventricular catheter. The optic nerve sheath diameter (ONSD) has been described as a highly sensitive (88-94%) and specific (85% - 94%) noninvasive technique of identifying increased intracranial pressures in patients with brain trauma, intracranial bleeding or stroke[1-4]. This method requires placement of an ultrasound probe on the patient's closed eyelid and then a direct measurement of the diameter of the optic nerve sheath at a pre-specified distance from the globe. A value greater than 58 mm has been shown to correlate significantly with an increased ICP (> 20 cm H20); r = 0.71, p<0.001 [5]. The investigators hypothesize that bedside ultrasound measurement of the ONSD is a simple screening test for increased intracranial pressure and can be used to rapidly and efficiently identify patients in the ICU who have coma due to an increase in intracranial pressure. The investigators propose to carry out an observational trial to determine the predictive ability of the Optic Nerve Sheath Diameter for cerebral edema/ increased intracranial pressure and to compare it with the results of neuroimaging (CT and/or MRI).

NCT ID: NCT02329028 Completed - Epilepsy Clinical Trials

Feasibility of Mini-EEG in the Prehospital Setting

Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work. The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)