An observational study in Consciousness Disorder, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Disorders of consciousness frequently occur at the acute phase of brain injuries. For the most severe cases, consciousness impairment can be prolonged. To optimize the medical plan and the goal of care, it is fundamental to have precise tools to predict chances of recovery of consciousness and potential disability. Currently, multimodal assessment including behavioral, neurophysiological and neuroimaging technics is recommended. However, the respective predictive values of these markers are poorly understood and decision making is challenging when results are contradictory
Improved treatment of critically ill patients has resulted in increased patients' survival rates in Intensive Care Units (ICU). This is particularly true for brain injury such as traumatic brain injuries, cerebral hemorrhages or cardiac arrest. While some of these patients regain consciousness after a transient state known as coma, other will develop a prolonged disorder of consciousness (DoC) such as chronic unresponsive wakefulness syndrome (also known as vegetative state) or minimally conscious state, or will remain severely disabled. Consciousness diagnosis and prediction of recovery in DoC currently relies on standardized behavioral assessment and disease-specific markers. However, this strategy may fail to detect covert consciousness due to major sensory and motor deficits. Moreover, the DoC etiology and pathophysiology are heterogenous and most likely result from the combination of factors whose interplay still needs to be clarified. Consciousness detection in DoC is of great importance in term of medical management (e.g., pain management, communication), prognosis (e.g., orientation to adapted rehabilitation center to maximize chance of recovery) and end-of-life discussions (e.g., withholding and/or withdrawing of life support discussion). Furthermore, taking care of these patients can be very stressful due to the high levels of uncertainty associated to their potential of recovery. For all these reasons it is critical to develop personalized diagnosis and prognosis assessment tools that can allow better decisions.
The M-NeuroDoC study will take advantage from the state-of-the-art multimodal assessment ongoing at our institution for both acute and chronic patients in order to improve recovery prediction.
Indeed, our multimodal assessment practice constitutes a great and unique opportunity to better understand the respective diagnostic and prognostic accuracy performances of markers such as behavioral, electrophysiological and neuroimaging that are routinely performed at our institution.
The overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches.
Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
Data of interest will be:
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's planned enrollment of 500 is above the median of 79 across 86 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery) or with Brain injuries on CT or MRI
Exclusion Criteria:
The overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches. Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
Other: repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery
Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
prognosis accuracy of respective predictive markers of consciousness recovery
Calculation of the value (Chi2 tests, specificity, sensitivity, positive and negative predictive values of each tests and of their combinations to distinguish patients states and outcome (24-month GOS-E ≥ 4 or \< 4).
Time frame: 24 MONTHS
GOS-E Glasgow outcome scale - Extended
Evolution of GOS-E (Glasgow outcome scale - Extended) scale from category 1 ==\> Death to category 8: good recovery upper ==\>no current problems related to the brain injury that affect daily life
Time frame: 6, 12 and 18 months
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Assistance Publique - Hôpitaux de Paris