Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534777
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2020-03-27
Brief Title:
Multimodal Neuroprognostication in Disorders of Consciousness
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Multimodal Neuroprognostication in Disorders of Consciousness
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M-Neuro-DoC
Brief Summary:
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
Detailed Description:
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 eg pain management communication prognosis eg orientation to adapted rehabilitation center to maximize chance of recovery and end-of-life discussions eg withholding andor 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
repeated neurological assessments
repeated behavioural assessments suing validated tools
neurophysiological explorations
conventional brain imagery CT IRM
quantitative brain imagery
functional brain imagery mental imagery
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
repeated neurological assessments
repeated behavioural assessments suing validated tools
neurophysiological explorations
conventional brain imagery CT IRM
quantitative brain imagery
functional brain imagery mental imagery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None