Disorders of ConsciousnessPerBrainNCT04798456
Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations
An observational study of Disorders of Consciousness and Minimally Conscious State, run by Paris Brain Institute (ICM) at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Disorders of Consciousness, Minimally Conscious State, Unresponsive Wakefulness Syndrome
- What is being tested?
- Coma scales, Imaging, electrophysiology, body signals, and brain stimulation and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Jun 2020to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care units and rehabilitation centres
Who may be able to join
- Disorder of consciousness (UWS and MCS) patients and their caregiver/legal guardian
- Patient age: 18-85 years
- Informed consent signed by legal guardian
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
France1 site, 1 recruiting
- Recruiting
Paris Brain Institute (ICM)
Paris, 75013
Jacobo Sitt, MD/PhD, jacobo.sitt@icm-institute.org
Benjamin Rohaut, MD/PhD, benjamin.rohaut@icm-institute.org
Germany1 site, 1 recruiting
- Recruiting
University Hospital of the Ludwig-Maximilians-University of Munich
Munich, 81377
Andreas Bender, MD/Prof, andreas.bender@med.uni-muenchen.de
Theresa Raiser, PhD, theresa.raiser@med.uni-muenchen.de
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Hospital
Raanana, 43100
Noam Sobel, Prof, noam.sobel@weizmann.ac.il
Danielle Honigstein, PhD, danielle.honigstein@weizmann.ac.il
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA)
Milan
Angela Comanducci, MD, acomanducci@dongnocchi.it
About this study
Official title: A Multimodal Approach to Personalized Tracking of Evolving State-Of-Consciousness in Brain- Injured Patients
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.
- Conditions
- Disorders of Consciousness, Minimally Conscious State, Unresponsive Wakefulness Syndrome, Caregivers
- Being tested
- Coma scales, Imaging, electrophysiology, body signals, and brain stimulation, Questionnaires
- Keywords
- Clinical Neuroscience, Disorders of Consciousness, Neuroimaging, Brain-Body interactions, Multimodal precision diagnosis, Machine Learning, Caregivers well-being, Unresponsive wakefulness syndrome, Minimally conscious state
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma scalesBehavioural
CRS-R and GOSE
Imaging, electrophysiology, body signals, and brain stimulationDiagnostic test
MRI, fMRI, EEG, TMS-EEG, Olfaction, Respiration, EKG
QuestionnairesBehavioural
several questionnaires and an interview with the caregiver
| Study group | Role | What they receive |
|---|---|---|
| Patients with DoC | Not described Receives: Behavioral: Coma scales; Diagnostic Test: Imaging, electrophysiology, body signals, and brain stimulation | |
| Caregivers/ legal guardian of patients with DoC | Not described Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Coma Recovery Scale Revised (CRS-R) [0-23] Higher score better outcome
Measured: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Extended Glasgow Outcome Scale (GOSE) [1-8] Higher score better outcome
Measured: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Quantitative high density EEG (64 Electrodes)
Measured: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Standard EEG and transcranial magnetic stimulation (TMS-EEG)
Measured: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients
Structural MRI and functional MRI (without contrast agent)
Measured: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury
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
Sociodemographic characteristics
Measured: 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)
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
Brief Illness Perception Questionnaire (BIPQ) [0-80] Higher score more positive illness representation
Measured: 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)
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
Euro-Qol 5 (EQ-5D61) [0-15] higher values indicating better perceived quality of life.
Measured: 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)
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
Adult Carer Quality of Life Questionnaire (ACQoL24) [0-120] higher values better quality of life
Measured: 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)
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
Hospital Anxiety and Depression Scale (HADS) [0-52] higher scores indicating higher levels of anxiety and depression.
Measured: 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)
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
Resilience (RS14) [14-98] higher scores relate to higher resilience levels.
Measured: 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)
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
Sense of coherence (SOCS) [13-91] higher scores indicate higher sense of coherence.
Measured: 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)
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
Treatment choices survey [28-140] higher score indicates a stronger agreement with the treatment and higher reason to take a given treatment decision
Measured: 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)
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
Semi-structured qualitative Interview based on a thematic grid for brochure development
Measured: 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 (1)
Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jun 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paris Brain Institute (ICM)
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Fondazione Don Carlo Gnocchi ETS, Weizmann Institute of Science, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Jacobo Sitt, Paris Brain Institute (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798456
- Sponsor's protocol ID
- ERAPERMED2019-101 - PerBrain
- Other IDs
- 01KU2003
- Acronym
- PerBrain
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16350959Raimondo 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.
PubMed 28892566Arzi 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.
PubMed 32461641Casali 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.
PubMed 23946194Engemann 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.
PubMed 30285102Vogler 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.
PubMed 24945467Derchi CC, Comanducci A, Bassi M, Rosenfelder MJ, Valota C, Willacker L, Oehl P, Rosanova M, Sitt JD, Bender A, Kuehlmeyer K. Surrogate decision-making for people with disorders of consciousness: considering the control-preferences of informal caregivers before implementing multimodal testing. BMC Med Ethics. 2026 Jan 2;27(1):11. doi: 10.1186/s12910-025-01357-4.
PubMed 41484601Willacker L, Raiser TM, Bassi M, Bender A, Comanducci A, Rosanova M, Sobel N, Arzi A, Belloli L, Casarotto S, Colombo M, Derchi CC, Flo Rama E, Grill E, Hohl M, Kuehlmeyer K, Manasova D, Rosenfelder MJ, Valota C, Sitt JD. PerBrain: a multimodal approach to personalized tracking of evolving state-of-consciousness in brain-injured patients: protocol of an international, multicentric, observational study. BMC Neurol. 2022 Dec 9;22(1):468. doi: 10.1186/s12883-022-02958-x.
PubMed 36494776
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Approach to Personalized Tracking of Evolving State-Of-Consciousness in Brain- Injured Patients
- ClinicalTrials.gov ID
- NCT04798456
- Acronym / sponsor ID
- PerBrain / ERAPERMED2019-101 - PerBrain
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Paris Brain Institute (ICM)University, hospital or other
- Collaborators
- University of Milan, Fondazione Don Carlo Gnocchi ETS, Weizmann Institute of Science, Ludwig-Maximilians - University of Munich
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with DoC | – | Behavioral: Coma scales, Diagnostic Test: Imaging, electrophysiology, body signals, and brain stimulation |
| Caregivers/ legal guardian of patients with DoC | – | Behavioral: Questionnaires |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care units and rehabilitation centres
Key inclusion criteria (3 listed)
Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coma scalesCRS-R and GOSE | Behavioural | Patients with DoC |
| Imaging, electrophysiology, body signals, and brain stimulationMRI, fMRI, EEG, TMS-EEG, Olfaction, Respiration, EKG | Diagnostic test | Patients with DoC |
| Questionnairesseveral questionnaires and an interview with the caregiver | Behavioural | Caregivers/ legal guardian of patients with DoC |
Primary outcome
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
Coma Recovery Scale Revised (CRS-R) [0-23] Higher score better outcome
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
Extended Glasgow Outcome Scale (GOSE) [1-8] Higher score better outcome
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
Quantitative high density EEG (64 Electrodes)
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
Standard EEG and transcranial magnetic stimulation (TMS-EEG)
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
Structural MRI and functional MRI (without contrast agent)
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)
Sociodemographic characteristics
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)
Brief Illness Perception Questionnaire (BIPQ) [0-80] Higher score more positive illness representation
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)
Euro-Qol 5 (EQ-5D61) [0-15] higher values indicating better perceived quality of life.
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)
Adult Carer Quality of Life Questionnaire (ACQoL24) [0-120] higher values better quality of life
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)
Hospital Anxiety and Depression Scale (HADS) [0-52] higher scores indicating higher levels of anxiety and depression.
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)
Resilience (RS14) [14-98] higher scores relate to higher resilience levels.
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)
Sense of coherence (SOCS) [13-91] higher scores indicate higher sense of coherence.
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)
Treatment choices survey [28-140] higher score indicates a stronger agreement with the treatment and higher reason to take a given treatment decision
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)
Semi-structured qualitative Interview based on a thematic grid for brochure development
1 secondary outcome
Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 16350959Giacino 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.
- Background: PubMed 28892566Raimondo 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.
- Background: PubMed 32461641Arzi 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.
- Background: PubMed 23946194Casali 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.
- Background: PubMed 30285102Engemann 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.
- Background: PubMed 24945467Vogler 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.
- Derived from this study: PubMed 41484601Derchi CC, Comanducci A, Bassi M, Rosenfelder MJ, Valota C, Willacker L, Oehl P, Rosanova M, Sitt JD, Bender A, Kuehlmeyer K. Surrogate decision-making for people with disorders of consciousness: considering the control-preferences of informal caregivers before implementing multimodal testing. BMC Med Ethics. 2026 Jan 2;27(1):11. doi: 10.1186/s12910-025-01357-4.
- Derived from this study: PubMed 36494776Willacker L, Raiser TM, Bassi M, Bender A, Comanducci A, Rosanova M, Sobel N, Arzi A, Belloli L, Casarotto S, Colombo M, Derchi CC, Flo Rama E, Grill E, Hohl M, Kuehlmeyer K, Manasova D, Rosenfelder MJ, Valota C, Sitt JD. PerBrain: a multimodal approach to personalized tracking of evolving state-of-consciousness in brain-injured patients: protocol of an international, multicentric, observational study. BMC Neurol. 2022 Dec 9;22(1):468. doi: 10.1186/s12883-022-02958-x.
- Individual participant dataSharing planned: No
Related trials for Disorders of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness and Minimally Conscious State, run by Paris Brain Institute (ICM) at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacobo Sitt, MD/PhD (+33 (0)1 57 27 40 00, jacobo.sitt@icm-institute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798456, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.