University Hospital, Basel, Switzerland — Biomedical Watch V2

Traitements12programmes

Essais6liés

Publications7liées

SourceDBlocale

Traitements

12

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are partly independent of lesion formation and relapse activity , but represent the direct driver of clinical long-term disability and cognitive decline. Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and numerical data which are closely correlated to the EDSS. As EP capture the functional integrity of the examined systems they represent a method unbiased for directional changes, while remaining specific for the neuronal function, and hence can measure deterioration, as well as improvement, a germane advantage to capture drug response. High-resolution electroencephalography (EEG) allow for explorative analysis of potential surrogate markers for cognitive decline. Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense lesions as well as on the annualized relapse rate in a recent phase II trial in relapsing-remitting MS. The present study will investigate the effects of OCR on multimodal evoked potentials (EP), Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue will be explored.	SEP	À vérifier	Immunomodulation	Switzerland	À vérifier
CHOOSE-POC — Micro-choice-based Intervention for Multicausal FatigueThis proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.	Myopathies	Non applicable	Traitement symptomatique	Switzerland	À vérifier
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance TomographyIn systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. We studied whether a comprehensive cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart disease in SLE patients without known CAD	Lupus	À vérifier	À vérifier	Switzerland	À vérifier
Copeptin in Childhood EpilepsyIn many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.	Épilepsie	À vérifier	À vérifier	Switzerland	À vérifier
INsIDER — Imaging the Interplay Between Axonal Damage and Repair in Multiple SclerosisThis project is to: 1. Quantify differences in axonal integrity and organization in aMS versus naPMS patients. 2. Quantify changes in axonal integrity and organization in aMS versus naPMS patients over a two-year period. 3. Validate the combination of imaging parameters that best differentiate aMS versus naPMS patients using histopathology.	SEP	À vérifier	Neuroprotection	Switzerland	À vérifier
SMSC — Swiss Multiple Sclerosis Cohort-StudyThe Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are 1. To maintain a long-term cohort for an undefined duration of patients with Multiple Sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in Switzerland. This requires effective measures to limit drop-outs and the continuous recruitment of MS patients and 2. To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids. The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data. Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the: 1. Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response. 2. Exploration of the safety and impact on long-term disability of existing and next generation MS treatments 3. Individualized therapy: A number of highly active but potentially also harmful therapies have lately been established for the treatment of MS. To date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it. 4. Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.	SEP	À vérifier	Remyélinisation	Switzerland	À vérifier
Copeptin in Childhood EpilepsyIn many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.	Épilepsie	À vérifier	À vérifier	Switzerland	À vérifier
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance TomographyIn systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. We studied whether a comprehensive cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart disease in SLE patients without known CAD	Lupus	À vérifier	À vérifier	Switzerland	À vérifier
Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are partly independent of lesion formation and relapse activity , but represent the direct driver of clinical long-term disability and cognitive decline. Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and numerical data which are closely correlated to the EDSS. As EP capture the functional integrity of the examined systems they represent a method unbiased for directional changes, while remaining specific for the neuronal function, and hence can measure deterioration, as well as improvement, a germane advantage to capture drug response. High-resolution electroencephalography (EEG) allow for explorative analysis of potential surrogate markers for cognitive decline. Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense lesions as well as on the annualized relapse rate in a recent phase II trial in relapsing-remitting MS. The present study will investigate the effects of OCR on multimodal evoked potentials (EP), Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue will be explored.	SEP	À vérifier	Immunomodulation	Switzerland	À vérifier
INsIDER — Imaging the Interplay Between Axonal Damage and Repair in Multiple SclerosisThis project is to: 1. Quantify differences in axonal integrity and organization in aMS versus naPMS patients. 2. Quantify changes in axonal integrity and organization in aMS versus naPMS patients over a two-year period. 3. Validate the combination of imaging parameters that best differentiate aMS versus naPMS patients using histopathology.	SEP	À vérifier	Neuroprotection	Switzerland	À vérifier
CHOOSE-POC — Micro-choice-based Intervention for Multicausal FatigueThis proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.	Myopathies	Non applicable	Traitement symptomatique	Switzerland	À vérifier
SMSC — Swiss Multiple Sclerosis Cohort-StudyThe Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are 1. To maintain a long-term cohort for an undefined duration of patients with Multiple Sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in Switzerland. This requires effective measures to limit drop-outs and the continuous recruitment of MS patients and 2. To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids. The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data. Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the: 1. Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response. 2. Exploration of the safety and impact on long-term disability of existing and next generation MS treatments 3. Individualized therapy: A number of highly active but potentially also harmful therapies have lately been established for the treatment of MS. To date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it. 4. Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.	SEP	À vérifier	Remyélinisation	Switzerland	À vérifier

Essais cliniques

6

Molécule	Indication / population	Phase	NCT	Titre	Statut
SMSC — Swiss Multiple Sclerosis Cohort-Study	SEP	À vérifier	NCT02433028	SMSC — Swiss Multiple Sclerosis Cohort-Study	RECRUITING
CHOOSE-POC — Micro-choice-based Intervention for Multicausal Fatigue	Myopathies	Non applicable	NCT07726082	CHOOSE-POC — Micro-choice-based Intervention for Multicausal Fatigue	RECRUITING
INsIDER — Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis	SEP	À vérifier	NCT05177523	INsIDER — Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis	RECRUITING
Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and	SEP	À vérifier	NCT01765361	Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG)	COMPLETED
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography	Lupus	À vérifier	NCT03488654	CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography	TERMINATED
Copeptin in Childhood Epilepsy	Épilepsie	À vérifier	NCT01884766	Copeptin in Childhood Epilepsy	COMPLETED

Publications

7

Molécule	Indication / population	Titre	Journal	Date
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography		Feasibility and Yield of a Diagnostic Protocol for Myocardial Infarction With Nonobstructive Coronary Arteries.	The American journal of cardiology
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography		Electrophysiology-MRI integration for epileptogenic zone detection and surgical prediction - A narrative review.	Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography		Morphological and Epidemiological Analysis of the Sphenoid Sinus Based on Computed Tomography and Magnetic Resonance Imaging: A Narrative Review.	Life (Basel, Switzerland)
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography		Validation of the VasCog-2-WSO VCID Criteria in a Dementia-Free and Stroke-Free Community Cohort: Cardiovascular Risk and Mortality.	Neurology
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography		Integrating cardiac CT into the diagnostic pathway of Takotsubo syndrome: current evidence and future directions.	European journal of radiology
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography		Left ventricular non-compaction in heart failure: contemporary perspective on diagnostic challenges and treatment opportunities.	Heart failure reviews
Copeptin in Childhood Epilepsy		Serum Neurofilament Levels in Children With Febrile Seizures and in Controls.	Frontiers in neuroscience