Status:
UNKNOWN
Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations
Lead Sponsor:
Paris Brain Institute (ICM)
Collaborating Sponsors:
University of Milan
Fondazione Don Carlo Gnocchi Onlus
Conditions:
Disorders of Consciousness
Minimally Conscious State
Eligibility:
All Genders
18-85 years
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 o...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04798456
Start Date
June 1 2020
End Date
June 1 2023
Last Update
March 15 2021
Active Locations (4)
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1
Paris Brain Institute (ICM)
Paris, France, 75013
2
University Hospital of the Ludwig-Maximilians-University of Munich
Munich, Germany, 81377
3
Loewenstein Hospital
Raanana, Israel, 43100
4
Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA)
Milan, Italy