- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798456
Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations (PerBrain)
A Multimodal Approach to Personalized Tracking of Evolving State-Of-Consciousness in Brain- Injured Patients
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jacobo Sitt, MD/PhD
- Phone Number: +33 (0)1 57 27 40 00
- Email: jacobo.sitt@icm-institute.org
Study Contact Backup
- Name: Benjamin Rohaut, MD/PhD
- Phone Number: +33 (0)1 57 27 40 00
- Email: benjamin.rohaut@icm-institute.org
Study Locations
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Paris, France, 75013
- Recruiting
- Paris Brain Institute (ICM)
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Contact:
- Jacobo Sitt, MD/PhD
- Email: jacobo.sitt@icm-institute.org
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Contact:
- Benjamin Rohaut, MD/PhD
- Email: benjamin.rohaut@icm-institute.org
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Munich, Germany, 81377
- Recruiting
- University Hospital of the Ludwig-Maximilians-University of Munich
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Contact:
- Andreas Bender, MD/Prof
- Email: andreas.bender@med.uni-muenchen.de
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Contact:
- Theresa Raiser, PhD
- Email: theresa.raiser@med.uni-muenchen.de
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Raanana, Israel, 43100
- Recruiting
- Loewenstein Hospital
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Contact:
- Noam Sobel, Prof
- Email: noam.sobel@weizmann.ac.il
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Contact:
- Danielle Honigstein, PhD
- Email: danielle.honigstein@weizmann.ac.il
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Milan, Italy
- Recruiting
- Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA)
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Contact:
- Angela Comanducci, MD
- Email: acomanducci@dongnocchi.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with DoC
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CRS-R and GOSE
MRI, fMRI, EEG, TMS-EEG, Olfaction, Respiration, EKG
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Caregivers/ legal guardian of patients with DoC
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several questionnaires and an interview with the caregiver
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Time Frame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Coma Recovery Scale Revised (CRS-R) [0-23] Higher score better outcome
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Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Time Frame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Extended Glasgow Outcome Scale (GOSE) [1-8] Higher score better outcome
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Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Time Frame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Quantitative high density EEG (64 Electrodes)
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Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Time Frame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Standard EEG and transcranial magnetic stimulation (TMS-EEG)
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Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Time Frame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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Structural MRI and functional MRI (without contrast agent)
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Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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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
Time Frame: 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)
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Sociodemographic characteristics
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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)
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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
Time Frame: 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)
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Brief Illness Perception Questionnaire (BIPQ) [0-80] Higher score more positive illness representation
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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)
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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
Time Frame: 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)
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Euro-Qol 5 (EQ-5D61) [0-15] higher values indicating better perceived quality of life.
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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)
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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
Time Frame: 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)
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Adult Carer Quality of Life Questionnaire (ACQoL24) [0-120] higher values better quality of life
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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)
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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
Time Frame: 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)
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Hospital Anxiety and Depression Scale (HADS) [0-52] higher scores indicating higher levels of anxiety and depression.
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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)
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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
Time Frame: 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)
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Resilience (RS14) [14-98] higher scores relate to higher resilience levels.
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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)
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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
Time Frame: 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)
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Sense of coherence (SOCS) [13-91] higher scores indicate higher sense of coherence.
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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)
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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
Time Frame: 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)
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Treatment choices survey [28-140] higher score indicates a stronger agreement with the treatment and higher reason to take a given treatment decision
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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)
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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
Time Frame: 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)
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Semi-structured qualitative Interview based on a thematic grid for brochure development
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results
Time Frame: 12 months
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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. |
12 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Casali AG, Gosseries O, Rosanova M, Boly M, Sarasso S, Casali KR, Casarotto S, Bruno MA, Laureys S, Tononi G, Massimini M. A theoretically based index of consciousness independent of sensory processing and behavior. Sci Transl Med. 2013 Aug 14;5(198):198ra105. doi: 10.1126/scitranslmed.3006294.
- 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.
- Engemann DA, Raimondo F, King JR, Rohaut B, Louppe G, Faugeras F, Annen J, Cassol H, Gosseries O, Fernandez-Slezak D, Laureys S, Naccache L, Dehaene S, Sitt JD. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain. 2018 Nov 1;141(11):3179-3192. doi: 10.1093/brain/awy251.
- Raimondo F, Rohaut B, Demertzi A, Valente M, Engemann DA, Salti M, Fernandez Slezak D, Naccache L, Sitt JD. Brain-heart interactions reveal consciousness in noncommunicating patients. Ann Neurol. 2017 Oct;82(4):578-591. doi: 10.1002/ana.25045. Epub 2017 Oct 11.
- Arzi A, Rozenkrantz L, Gorodisky L, Rozenkrantz D, Holtzman Y, Ravia A, Bekinschtein TA, Galperin T, Krimchansky BZ, Cohen G, Oksamitni A, Aidinoff E, Sacher Y, Sobel N. Olfactory sniffing signals consciousness in unresponsive patients with brain injuries. Nature. 2020 May;581(7809):428-433. doi: 10.1038/s41586-020-2245-5. Epub 2020 Apr 29.
- Vogler J, Klein AM, Bender A. Long-term health-related quality-of-life in patients with acquired brain injury and their caregivers. Brain Inj. 2014;28(11):1381-8. doi: 10.3109/02699052.2014.919536. Epub 2014 Jun 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERAPERMED2019-101 - PerBrain
- 01KU2003 (Other Grant/Funding Number: Federal ministry for education and research (Germany))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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