Clinical trial NCT04534777: Multimodal Neuroprognostication in Disorders of Consciousness
Official title: Multimodal Neuroprognostication in Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Consciousness Disorder
Keywords: electroencephalography
evoked potentials
functional magnetic resonance imaging
minimally conscious state
positron emission tomography
resting state fMRI (functional magnetic resonance imaging )
transcranial magnetic stimulation
traumatic brain injury
unresponsive wakefulness syndrome
vegetative state
polysomnography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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 (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:

* repeated neurological assessments
* repeated behavioural assessments suing validated tools:
* neurophysiological explorations
* conventional brain imagery (CT, IRM)
* quantitative brain imagery
* functional brain imagery , mental imagery

Eligibility criteria: Inclusion Criteria:

1. Consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery)
2. Brain injuries on CT or MRI (e.g. TBI) (traumatic brain-injured ), anoxia or stroke related lesions, etc...)
3. Age between 18 and 80 years

Exclusion Criteria:

1. Deep sedation (e.g. elevated ICP(intracranial pressure ), refractory status epilepticus)
2. Sever known neurodegenerative disease (e.g. Alzheimer disease)
3. Pregnancy

Primary outcomes:
measure: prognosis accuracy of respective predictive markers of consciousness recovery
timeFrame: 24 MONTHS
Secondary outcomes:
measure: GOS-E Glasgow outcome scale - Extended
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
Study officials:
References:
citation: Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
citation: Hermann B, Goudard G, Courcoux K, Valente M, Labat S, Despois L, Bourmaleau J, Richard-Gilis L, Faugeras F, Demeret S, Sitt JD, Naccache L, Rohaut B; Pitie-Salpetriere hospital Neuro-ICU. Wisdom of the caregivers: pooling individual subjective reports to diagnose states of consciousness in brain-injured patients, a monocentric prospective study. BMJ Open. 2019 Feb 21;9(2):e026211. doi: 10.1136/bmjopen-2018-026211.
citation: Andre-Obadia N, Zyss J, Gavaret M, Lefaucheur JP, Azabou E, Boulogne S, Guerit JM, McGonigal A, Merle P, Mutschler V, Naccache L, Sabourdy C, Trebuchon A, Tyvaert L, Vercueil L, Rohaut B, Delval A. Recommendations for the use of electroencephalography and evoked potentials in comatose patients. Neurophysiol Clin. 2018 Jun;48(3):143-169. doi: 10.1016/j.neucli.2018.05.038. Epub 2018 May 18.
citation: Balanca B, Dailler F, Boulogne S, Ritzenthaler T, Gobert F, Rheims S, Andre-Obadia N. Diagnostic accuracy of quantitative EEG to detect delayed cerebral ischemia after subarachnoid hemorrhage: A preliminary study. Clin Neurophysiol. 2018 Sep;129(9):1926-1936. doi: 10.1016/j.clinph.2018.06.013. Epub 2018 Jul 5.