Clinical trial NCT04798456: Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations
Official title: A Multimodal Approach to Personalized Tracking of Evolving State-Of-Consciousness in Brain- Injured Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorders of Consciousness
Minimally Conscious State
Unresponsive Wakefulness Syndrome
Caregivers
Keywords: Clinical Neuroscience
Disorders of Consciousness
Neuroimaging
Brain-Body interactions
Multimodal precision diagnosis
Machine Learning
Caregivers well-being
Unresponsive wakefulness syndrome
Minimally conscious state
Lead sponsor: Paris Brain Institute (ICM)
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Fondazione Don Carlo Gnocchi Onlus
name: Weizmann Institute of Science
name: Ludwig-Maximilians - University of Munich
First posted: 2021-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: intensive care units and rehabilitation centres

Brief summary: Improved treatment of severe brain injuries has resulted in increased survival rates. While some of these patients regain consciousness after a transient state of coma, others may develop a disorder of consciousness (DoC). Diagnosis of DoC currently relies on standardized behavioral assessment. The importance of accuracy in such diagnosis cannot be overstated, as it guides critical decisions on treatment (including pain management), and could underlie end-of-life decisions. Despite this importance, current behavioral diagnosis often fails, if because of the major sensory and motor deficits associated with DoC, or because of the heterogeneous etiology and pathophysiology associated with the condition. Finally, the need for accurate diagnosis and prognosis transcends the needs of the patients alone: caregiving of these patients is very stressful, principally for the large uncertainty associated with them. Thus, more accurate diagnosis and prognosis provide major relief for caregivers, and paradoxically, even if the news is not "good". For all these reasons it is critical to developing personalized diagnosis and prognosis prediction tools that permit a stratified analysis at the single-patient level. The PerBrain Project will benefit from the multidisciplinary partners' expertise, and the unique opportunity to perform longitudinal assessments in four clinical sites through both established and novel electrophysiological, neuroimaging, and physiological techniques. Based on the collected data, the investigators will develop a multimodal personalized diagnostic tool for DoC patients using state-of-the-art computational tools, such as machine learning, in order to better determine the current state (diagnosis) and future outcome (prognosis). The overall aim of this project will provide for a better understanding of the pathophysiological mechanisms in DoC, which will, in turn, allow personalized rehabilitation strategies, and improved single-patient predictions of state and prognosis.


Eligibility criteria: * Recruitment is taking place in:

  * France, Paris, Pitie-Salpetriere Hospital;
  * Italy, Milan, Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA);
  * Israel, Raanana, Loewenstein Hospital;
  * Germany, Munich: intensive care units of the University Clinic LMU Munich and Therapiezentrum Burgau
* Inclusion criteria:

  * Disorder of consciousness (UWS and MCS) patients and their caregiver/legal guardian
  * Patient age: 18-85 years
  * Informed consent signed by legal guardian
* Exclusion criteria:

  * Pregnancy
  * Pre-existing coma/VS/MCS
  * Continuous medical sedation (induced coma)
  * Use of barbiturates for sedation
  * Terminal malignant disease, as it increases the likelihood of not being alive for the 12-month follow-up
  * Prediction of a highly unlikely survival until the time of the 12-month follow-up due to conditions such as multi-organ failure based on the judgement of a critical care physician
  * Withdrawal of life-support
  * Palliative care setting
  * Epileptic seizures (TMS contraindication)
  * MRI contraindications (magnetic material in or on person such as pacemakers, cochlear implants, shell splinters, metal plates, certain prosthetic joints/limbs, copper-based intrauterine device, magnetic clips or stents, some large tattoos)

Primary outcomes:
measure: Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
timeFrame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
measure: Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
timeFrame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
measure: Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
timeFrame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
measure: Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
timeFrame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
measure: Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
timeFrame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from 0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
measure: Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients
timeFrame: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)
Secondary outcomes:
measure: Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Brain Institute (ICM)
city: Munich
country: Germany
facility: University Hospital of the Ludwig-Maximilians-University of Munich
city: Raanana
country: Israel
facility: Loewenstein Hospital
city: Milan
country: Italy
facility: Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA)
Study officials:
References:
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