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

• Conditions: Unresponsive Wakefulness Syndrome; Caregivers; Minimally Conscious State; Disorders of Consciousness
• Interventions: Behavioral: Coma scales; Behavioral: Questionnaires; Diagnostic Test: Imaging, electrophysiology, body signals, and brain stimulation

• Registration Number: NCT04798456
• Lead Sponsor: Paris Brain Institute (ICM)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with DoC	Coma scales	-
Patients with DoC	Imaging, electrophysiology, body signals, and brain stimulation	-
Caregivers/ legal guardian of patients with DoC	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
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	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)	Semi-structured qualitative Interview based on a thematic grid for brochure development
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients	Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury	Structural MRI and functional MRI (without contrast agent)

Secondary Outcome Measures

Name	Time	Method
Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results	12 months	Working 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.

Trial Locations

Locations (4)

Paris Brain Institute (ICM); 🇫🇷 Paris, France

University Hospital of the Ludwig-Maximilians-University of Munich; 🇩🇪 Munich, Germany

Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA); 🇮🇹 Milan, Italy

Loewenstein Hospital; 🇮🇱 Raanana, Israel