Clinical Trial: CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: CONNECT-ME: CONsciousness in NEurocritical Care cohorT Study Using fMRI and EEG
Brief Summary: Detecting preserved consciousness in brain-injured patients by traditional clinical means requires presence of motor function. Otherwise, patients may be erroneously classified as being in a vegetative state. In order to circumvent the need for motor function, paradigms using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) have been developed. According to a recent meta-analysis, 15% of patients with a clinical diagnosis of vegetative state can follow commands by performing mental imaginary tasks, strongly suggesting they are indeed conscious. This is of utmost importance for prognosis, treatment, and resource allocation. However, consciousness paradigms are usually employed in rehabilitation medicine. Therefore, opportunities to optimize patient outcome at an early stage may be lost. As a novel approach, the CONsciousness in NEurocritical Care cohorT study using fMRI and EEG (CONNECT-ME) will import the full range of consciousness paradigms into neurocritical care. The investigators aim to assess patients with acute brain injury for preserved consciousness by serial multimodal evaluations using active, passive and resting state fMRI- and EEG-based paradigms. A prospective longitudinal database and a biobank for genomic and metabolomic research will be established. This approach will add essential clinical information, including detection of preserved consciousness in patients previously thought of as unconscious. Due to its complexity, this project is divided into nine work packages. Eventually, the investigators will have established a clinical service for the systematic assessment of covert consciousness, as well as an interdisciplinary research group dedicated to the neuronal mechanisms by which consciousness recovers after acute brain injury.
Detailed Summary:
Searching for consciousness in non-communicating brain-injured patients by clinical examination is essential, yet challenging. The origin of many clinical signs is not entirely clear and their significance as to whether or not the patient is conscious is even less certain. In addition, consciousness may wax and wane within seconds to hours and days to months. Indeed, as many as 40% of patients with disorders of consciousness (DoC) are misclassified as being in a vegetative state (VS). Although these patients may not show any signs of consciousness during clinical examination because of lost motor output, some are able to willfully modulate their brain activity on command, occasionally even answering yes or no questions by performing mental imagery tasks. For patients with acute brain injury and their caregivers, this has significant ethical and practical implications, not least for prognostication, treatment decisions, resource allocation and end-of-life considerations.
Technologies based on functional Magnetic Resonance Imaging (fMRI) and electroencephalography (EEG) have been developed during the last two decades to assist clinical evaluation of patients in VS and minimal conscious states (MCS). There are three main approaches to test for preserved consciousness: (i) Active paradigms in which patients are required to execute cognitive tasks, as outlined above, (ii) passive paradigms relying on the documentation of preserved large-scale functional cortical connectivity, following an external stimulus, and (iii) resting state conditions in which assumptions about the patient's conscious state are made by extrapolation from patterns of spontaneous brain activity. Consciousness paradigms offer exciting opportunities but so far they have been almost exclusively employed in rehabilitation medicine, addressing patients with chronic brain disorders, typically several years foll
Sponsor: Rigshospitalet, Denmark
Current Primary Outcome: Numbers of patients with acute brain injury and signs of preserved consciousness as revealed by fMRI- and EEG-based active, passive and resting state consciousness paradigms [ Time Frame: 4 years ]
The investigators aim to rigorously and systematically examine non-communicating patients with acute brain injury for preserved consciousness by means of active, passive and resting state fMRI- and EEG-based consciousness paradigms, as well as standardized clinical rating scales such as the JFK Coma Recovery Scale-Revised. The degree of consciousness in a given patient will be estimated by using a composite reference standard comprising all available fMRI- and EEG-derived as well as clinical data as previously described in a review and meta-analysis by the investigators.
The target condition (primary outcome) is defined as signs of preserved consciousness in non-communicating patients with DoC due to traumatic brain injury (TBI), cerebrovascular disorders (CVA; including ischemic and hemorrhagic stroke, subarachnoid hemorrhage and cerebral venous sinus thrombosis), anoxic-ischemic encephalopathy (e.g., due to cardiac arrest) and similar critical brain disorders.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Rigshospitalet, Denmark
Dates:
Date Received: December 25, 2015
Date Started: April 12, 2017
Date Completion: December 2021
Last Updated: April 29, 2017
Last Verified: April 2017
