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Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations

A Multimodal Approach to Personalized Tracking of Evolving State-Of-Consciousness in Brain- Injured Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04798456
Acronym
PerBrain
Enrollment
150
Registered
2021-03-15
Start date
2020-06-01
Completion date
2023-06-30
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers, Disorders of Consciousness, Minimally Conscious State, Unresponsive Wakefulness Syndrome

Keywords

Clinical Neuroscience, Disorders of Consciousness, Neuroimaging, Brain-Body interactions, Multimodal precision diagnosis, Machine Learning, Caregivers well-being, Unresponsive wakefulness syndrome, Minimally conscious state

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.

Interventions

BEHAVIORALComa scales

CRS-R and GOSE

DIAGNOSTIC_TESTImaging, electrophysiology, body signals, and brain stimulation

MRI, fMRI, EEG, TMS-EEG, Olfaction, Respiration, EKG

BEHAVIORALQuestionnaires

several questionnaires and an interview with the caregiver

Sponsors

University of Milan
CollaboratorOTHER
Fondazione Don Carlo Gnocchi Onlus
CollaboratorOTHER
Weizmann Institute of Science
CollaboratorOTHER
Ludwig-Maximilians - University of Munich
CollaboratorOTHER
Paris Brain Institute (ICM)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patientsChanges from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injuryComa Recovery Scale Revised (CRS-R) \[0-23\] Higher score better outcome
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 patientsChanges 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)Sociodemographic characteristics

Secondary

MeasureTime frameDescription
Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results12 monthsWorking closely with Patient organizations/ patient representatives: Representatives of organizations (Schädel- Hirnpatienten in Not e.V. in Germany) will be consulted in focus groups to jointly discuss the met and unmet needs and communication problems reported by caregivers in the study. Additionally, we will conduct a semi-structures interview with the caregivers. This information will help to devise with the research team effective communication strategies to be implemented in a brochure for the presentation of multimodal technology-based DOC testing.

Countries

France, Germany, Israel, Italy

Contacts

Primary ContactJacobo Sitt, MD/PhD
jacobo.sitt@icm-institute.org+33 (0)1 57 27 40 00
Backup ContactBenjamin Rohaut, MD/PhD
benjamin.rohaut@icm-institute.org+33 (0)1 57 27 40 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026