[FG] Engelter StefanHead of Research Unit Prof. Dr. med.Stefan EngelterOverviewMembersPublicationsProjects & CollaborationsProjects & Collaborations OverviewMembersPublicationsProjects & Collaborations Projects & Collaborations 5 foundShow per page10 10 20 50 Targeting secondary injury in intracerebral hemorrhage – neuroimaging and genetic insights from the iDEF randomized trial Research Project | 1 Project MembersImported from Grants Tool 4694712 ENDOVASCULAR TREATMENT AND THROMBOLYSIS IN ISCHEMIC STROKE PATIENTS (EVA-TRISP) Research Project | 2 Project MembersThe major aim of EVA-TRISP is to address clinically important questions about safety and outcomes in AIS patients treated with IVT and/or EVT that are not covered by RCTs. The idea of EVA-TRISP is that experienced stroke centres with a record and expertise in both: (1) usage of IVT and/or EVT and (2) maintenance of hospital-basedstroke databases pool their data. In addition to the characteristics of the EVA-TRISP centres stated previously, an advantage of EVA-TRISP is the availability of more additional variables than in other large-scale registries and the commitment by the collaborators to: (1) submit accurate and complete data and to (2) be willing to adapt the local databases and quickly add new variables retrospectively and prospectively. Recovery of mobility function and life-space mobility after ischemic stroke (MOBITEC-Stroke) Research Project | 9 Project MembersSchlaganfälle zählen zu den häufigsten Todesursachen und mit dem Alter steigt die Wahrscheinlichkeit, einen Schlaganfall zu erleiden. Wird ein Schlaganfall überlebt, so bleiben oft Behinderungen zurück. Häufig ist die Mobilität betroffen. Diese umfasst sowohl die Fähigkeit sich zu bewegen, als auch die Fähigkeit, den Lebensraum optimal zu nutzen. Hauptziel des Projektes ist es, Veränderungen der Mobilität von Patienten im ersten Jahr nach Schlaganfall zu charakterisieren. Hierbei stellt sich insbesondere die Frage, welche Erholungsverläufe von welchen Patientenmerkmalen begünstigt werden. Zudem sollen motivationale Aspekte sowie Umgebungsfaktoren untersucht werden, welche die Mobilität erleichtern oder erschweren können. Hierzu werden etwa 60 Patienten, die erstmalig einen Schlaganfall erlitten haben, in die Studie eingeschlossen. Ein Jahr lang werden sich diese Patienten regelmässig Analysen der funktionellen und der räumlichen Mobilität unterziehen. Hierzu kommen laborbasierte Testverfahren (z. B. Kraft-, Balance- und Ganganalysen) und Messungen im täglichen Leben der Patienten (z. B. mittels GPS) zum Einsatz. Zudem werden die Patienten mittels digitaler Karten zu motivationalen Aspekten und Umgebungsfaktoren befragt. Die detaillierte Kenntnis unterschiedlicher Erholungsverläufe wird es ermöglichen, Rehabilitationsmassnahmen gezielt und zum idealen Zeitpunkt einzusetzen. Zudem wird das gewonnene Wissen die Festlegung individualisierter und motivierender Rehabilitationsziele ermöglichen. Enhancement of Stroke Rehabilitation with Levodopa (ESTREL): a randomized placebo-controlled trial Research Project | 3 Project MembersIn stroke medicine, the large body of high-quality evidence proving benefits of acute revascularization therapies and secondary prevention is offset by a large gap of evidence on means to enhance stroke recovery. Levodopa is a promising candidate for pharmacological enhancement of stroke recovery. Dopamine is a key player in processes of motor learning, reward, and brain plasticity. Preclinical research and studies with healthy individuals suggest, that there is scope for benefit from applying levodopa in addition to standardized rehabilitation. Indeed, there are some, however limited and inconsistent data from small randomized controlled trials (RCTs) testing levodopa in stroke patients. The largest, recently completed but not yet published "Dopamine in Rehabilitation of Stroke" (DARS)-trial did not indicate a benefit of levodopa. A preliminary meta-analysis across 6 RCTs (including DARS) indicated the possibility of a more favorable outcome in levodopa-treated stroke patients than in control patients. Heterogeneity between trials was considerable. The RCTs differed with regard to patient populations (chronic/acute stroke), types of stroke (ischemic/hemorrhagic), dosage and duration of the study treatment, length of follow-up, and outcome measures. None mentioned adaptation of concomitant rehabilitative therapies to the principles of motor learning. Of note, safety concerns were absent. Motor deficits are common and affect quality of life in stroke patients prompting for motor improvement as a top priority. Given the high prevalence and tremendous burden of stroke, a straightforward applicable measure to improve motor outcome is highly relevant. Given the promising but inconclusive clinical trial evidence on benefits, a well-designed, randomized controlled trial studying the usefulness of levodopa in enhancing motor recovery after stroke is warranted.Aim: to study whether levodopa compared to placebo given in addition to standardized rehabilitation based on the principles of motor learning is associated with a patient-relevant enhancement of functional recovery in acute ischemic stroke patients.Design: Multicenter, randomized (ratio 1:1), parallel-group, placebo-controlled superiority trial with blinded patients, care-providers, investigators, and outcome assessors.Patients: Patients with acute ischemic stroke (= 7days) causing clinically meaningful hemiparesis. Eligibility criteria: (i)in-hospital-rehabilitation required and patient capable to participate in standardized rehabilitation therapy; (ii)previous independence in daily living; (iii)absence of indications for dopaminergic agents; (iv)absence of contraindications for levodopa; (v)informed consent.Intervention: Levodopa 100mg/Carbidopa 25mg three times daily, administered for 5 weeks in addition to standardized rehabilitative therapy.Comparison: Matching placebo.Outcome Measures: The primary outcome is the between-group difference of final scores in the Fugl-Meyer-Motor Assessment-(FMA) measured 3 months after randomization. The FMA will also be assessed at the end of study treatment, at 6 and 12 months. Secondary outcomes include patient-reported outcomes, Rivermead Mobility Index, NIH-Stroke Scale score, modified Rankin Scale, Box-and-Block-Test, Jamar dynamometer test, and as measures of harm: mortality, recurrent stroke, and serious adverse events.Main statistical hypothesis: Levodopa administered in addition to standardized rehabilitative therapy is superior to placebo and standardized rehabilitative therapy, resulting in an at least 6 points higher FMA score at 3 months.Sample Size: 610 patients will be recruited. The sample size is estimated to detect a statistically significant and clinically meaningful difference between treatment groups of =6 points in the FMA at 3 months (primary outcome) assuming it is normally distributed with a standard deviation of 25 points (power 80%, two-sided significance level 5%, drop-out-rate 10%). Thrombolysis in Ischemic Stroke Patients (TRISP): a multicentre research collaboration Research Project | 2 Project MembersTRISP is an open, investigator-driven collaborative research initiative of European stroke centres with expertise in treatment with revascularisation therapies and maintenance of hospital-based registries. All participating centres made a commitment to prospectively collect data on consecutive patients with stroke treated with IVT using standardised definitions of variables and outcomes, to assure accuracy and completeness of the data and to adapt their local databases to answer novel research questions. TRISP aims to address clinically relevant questions about safety and outcomes of intravenous thrombolysis (IVT) and endovascular thrombectomy. The findings can provide observational information on treatment of patients derived from everyday clinical practice. 1 1 OverviewMembersPublicationsProjects & Collaborations
Projects & Collaborations 5 foundShow per page10 10 20 50 Targeting secondary injury in intracerebral hemorrhage – neuroimaging and genetic insights from the iDEF randomized trial Research Project | 1 Project MembersImported from Grants Tool 4694712 ENDOVASCULAR TREATMENT AND THROMBOLYSIS IN ISCHEMIC STROKE PATIENTS (EVA-TRISP) Research Project | 2 Project MembersThe major aim of EVA-TRISP is to address clinically important questions about safety and outcomes in AIS patients treated with IVT and/or EVT that are not covered by RCTs. The idea of EVA-TRISP is that experienced stroke centres with a record and expertise in both: (1) usage of IVT and/or EVT and (2) maintenance of hospital-basedstroke databases pool their data. In addition to the characteristics of the EVA-TRISP centres stated previously, an advantage of EVA-TRISP is the availability of more additional variables than in other large-scale registries and the commitment by the collaborators to: (1) submit accurate and complete data and to (2) be willing to adapt the local databases and quickly add new variables retrospectively and prospectively. Recovery of mobility function and life-space mobility after ischemic stroke (MOBITEC-Stroke) Research Project | 9 Project MembersSchlaganfälle zählen zu den häufigsten Todesursachen und mit dem Alter steigt die Wahrscheinlichkeit, einen Schlaganfall zu erleiden. Wird ein Schlaganfall überlebt, so bleiben oft Behinderungen zurück. Häufig ist die Mobilität betroffen. Diese umfasst sowohl die Fähigkeit sich zu bewegen, als auch die Fähigkeit, den Lebensraum optimal zu nutzen. Hauptziel des Projektes ist es, Veränderungen der Mobilität von Patienten im ersten Jahr nach Schlaganfall zu charakterisieren. Hierbei stellt sich insbesondere die Frage, welche Erholungsverläufe von welchen Patientenmerkmalen begünstigt werden. Zudem sollen motivationale Aspekte sowie Umgebungsfaktoren untersucht werden, welche die Mobilität erleichtern oder erschweren können. Hierzu werden etwa 60 Patienten, die erstmalig einen Schlaganfall erlitten haben, in die Studie eingeschlossen. Ein Jahr lang werden sich diese Patienten regelmässig Analysen der funktionellen und der räumlichen Mobilität unterziehen. Hierzu kommen laborbasierte Testverfahren (z. B. Kraft-, Balance- und Ganganalysen) und Messungen im täglichen Leben der Patienten (z. B. mittels GPS) zum Einsatz. Zudem werden die Patienten mittels digitaler Karten zu motivationalen Aspekten und Umgebungsfaktoren befragt. Die detaillierte Kenntnis unterschiedlicher Erholungsverläufe wird es ermöglichen, Rehabilitationsmassnahmen gezielt und zum idealen Zeitpunkt einzusetzen. Zudem wird das gewonnene Wissen die Festlegung individualisierter und motivierender Rehabilitationsziele ermöglichen. Enhancement of Stroke Rehabilitation with Levodopa (ESTREL): a randomized placebo-controlled trial Research Project | 3 Project MembersIn stroke medicine, the large body of high-quality evidence proving benefits of acute revascularization therapies and secondary prevention is offset by a large gap of evidence on means to enhance stroke recovery. Levodopa is a promising candidate for pharmacological enhancement of stroke recovery. Dopamine is a key player in processes of motor learning, reward, and brain plasticity. Preclinical research and studies with healthy individuals suggest, that there is scope for benefit from applying levodopa in addition to standardized rehabilitation. Indeed, there are some, however limited and inconsistent data from small randomized controlled trials (RCTs) testing levodopa in stroke patients. The largest, recently completed but not yet published "Dopamine in Rehabilitation of Stroke" (DARS)-trial did not indicate a benefit of levodopa. A preliminary meta-analysis across 6 RCTs (including DARS) indicated the possibility of a more favorable outcome in levodopa-treated stroke patients than in control patients. Heterogeneity between trials was considerable. The RCTs differed with regard to patient populations (chronic/acute stroke), types of stroke (ischemic/hemorrhagic), dosage and duration of the study treatment, length of follow-up, and outcome measures. None mentioned adaptation of concomitant rehabilitative therapies to the principles of motor learning. Of note, safety concerns were absent. Motor deficits are common and affect quality of life in stroke patients prompting for motor improvement as a top priority. Given the high prevalence and tremendous burden of stroke, a straightforward applicable measure to improve motor outcome is highly relevant. Given the promising but inconclusive clinical trial evidence on benefits, a well-designed, randomized controlled trial studying the usefulness of levodopa in enhancing motor recovery after stroke is warranted.Aim: to study whether levodopa compared to placebo given in addition to standardized rehabilitation based on the principles of motor learning is associated with a patient-relevant enhancement of functional recovery in acute ischemic stroke patients.Design: Multicenter, randomized (ratio 1:1), parallel-group, placebo-controlled superiority trial with blinded patients, care-providers, investigators, and outcome assessors.Patients: Patients with acute ischemic stroke (= 7days) causing clinically meaningful hemiparesis. Eligibility criteria: (i)in-hospital-rehabilitation required and patient capable to participate in standardized rehabilitation therapy; (ii)previous independence in daily living; (iii)absence of indications for dopaminergic agents; (iv)absence of contraindications for levodopa; (v)informed consent.Intervention: Levodopa 100mg/Carbidopa 25mg three times daily, administered for 5 weeks in addition to standardized rehabilitative therapy.Comparison: Matching placebo.Outcome Measures: The primary outcome is the between-group difference of final scores in the Fugl-Meyer-Motor Assessment-(FMA) measured 3 months after randomization. The FMA will also be assessed at the end of study treatment, at 6 and 12 months. Secondary outcomes include patient-reported outcomes, Rivermead Mobility Index, NIH-Stroke Scale score, modified Rankin Scale, Box-and-Block-Test, Jamar dynamometer test, and as measures of harm: mortality, recurrent stroke, and serious adverse events.Main statistical hypothesis: Levodopa administered in addition to standardized rehabilitative therapy is superior to placebo and standardized rehabilitative therapy, resulting in an at least 6 points higher FMA score at 3 months.Sample Size: 610 patients will be recruited. The sample size is estimated to detect a statistically significant and clinically meaningful difference between treatment groups of =6 points in the FMA at 3 months (primary outcome) assuming it is normally distributed with a standard deviation of 25 points (power 80%, two-sided significance level 5%, drop-out-rate 10%). Thrombolysis in Ischemic Stroke Patients (TRISP): a multicentre research collaboration Research Project | 2 Project MembersTRISP is an open, investigator-driven collaborative research initiative of European stroke centres with expertise in treatment with revascularisation therapies and maintenance of hospital-based registries. All participating centres made a commitment to prospectively collect data on consecutive patients with stroke treated with IVT using standardised definitions of variables and outcomes, to assure accuracy and completeness of the data and to adapt their local databases to answer novel research questions. TRISP aims to address clinically relevant questions about safety and outcomes of intravenous thrombolysis (IVT) and endovascular thrombectomy. The findings can provide observational information on treatment of patients derived from everyday clinical practice. 1 1
Targeting secondary injury in intracerebral hemorrhage – neuroimaging and genetic insights from the iDEF randomized trial Research Project | 1 Project MembersImported from Grants Tool 4694712
ENDOVASCULAR TREATMENT AND THROMBOLYSIS IN ISCHEMIC STROKE PATIENTS (EVA-TRISP) Research Project | 2 Project MembersThe major aim of EVA-TRISP is to address clinically important questions about safety and outcomes in AIS patients treated with IVT and/or EVT that are not covered by RCTs. The idea of EVA-TRISP is that experienced stroke centres with a record and expertise in both: (1) usage of IVT and/or EVT and (2) maintenance of hospital-basedstroke databases pool their data. In addition to the characteristics of the EVA-TRISP centres stated previously, an advantage of EVA-TRISP is the availability of more additional variables than in other large-scale registries and the commitment by the collaborators to: (1) submit accurate and complete data and to (2) be willing to adapt the local databases and quickly add new variables retrospectively and prospectively.
Recovery of mobility function and life-space mobility after ischemic stroke (MOBITEC-Stroke) Research Project | 9 Project MembersSchlaganfälle zählen zu den häufigsten Todesursachen und mit dem Alter steigt die Wahrscheinlichkeit, einen Schlaganfall zu erleiden. Wird ein Schlaganfall überlebt, so bleiben oft Behinderungen zurück. Häufig ist die Mobilität betroffen. Diese umfasst sowohl die Fähigkeit sich zu bewegen, als auch die Fähigkeit, den Lebensraum optimal zu nutzen. Hauptziel des Projektes ist es, Veränderungen der Mobilität von Patienten im ersten Jahr nach Schlaganfall zu charakterisieren. Hierbei stellt sich insbesondere die Frage, welche Erholungsverläufe von welchen Patientenmerkmalen begünstigt werden. Zudem sollen motivationale Aspekte sowie Umgebungsfaktoren untersucht werden, welche die Mobilität erleichtern oder erschweren können. Hierzu werden etwa 60 Patienten, die erstmalig einen Schlaganfall erlitten haben, in die Studie eingeschlossen. Ein Jahr lang werden sich diese Patienten regelmässig Analysen der funktionellen und der räumlichen Mobilität unterziehen. Hierzu kommen laborbasierte Testverfahren (z. B. Kraft-, Balance- und Ganganalysen) und Messungen im täglichen Leben der Patienten (z. B. mittels GPS) zum Einsatz. Zudem werden die Patienten mittels digitaler Karten zu motivationalen Aspekten und Umgebungsfaktoren befragt. Die detaillierte Kenntnis unterschiedlicher Erholungsverläufe wird es ermöglichen, Rehabilitationsmassnahmen gezielt und zum idealen Zeitpunkt einzusetzen. Zudem wird das gewonnene Wissen die Festlegung individualisierter und motivierender Rehabilitationsziele ermöglichen.
Enhancement of Stroke Rehabilitation with Levodopa (ESTREL): a randomized placebo-controlled trial Research Project | 3 Project MembersIn stroke medicine, the large body of high-quality evidence proving benefits of acute revascularization therapies and secondary prevention is offset by a large gap of evidence on means to enhance stroke recovery. Levodopa is a promising candidate for pharmacological enhancement of stroke recovery. Dopamine is a key player in processes of motor learning, reward, and brain plasticity. Preclinical research and studies with healthy individuals suggest, that there is scope for benefit from applying levodopa in addition to standardized rehabilitation. Indeed, there are some, however limited and inconsistent data from small randomized controlled trials (RCTs) testing levodopa in stroke patients. The largest, recently completed but not yet published "Dopamine in Rehabilitation of Stroke" (DARS)-trial did not indicate a benefit of levodopa. A preliminary meta-analysis across 6 RCTs (including DARS) indicated the possibility of a more favorable outcome in levodopa-treated stroke patients than in control patients. Heterogeneity between trials was considerable. The RCTs differed with regard to patient populations (chronic/acute stroke), types of stroke (ischemic/hemorrhagic), dosage and duration of the study treatment, length of follow-up, and outcome measures. None mentioned adaptation of concomitant rehabilitative therapies to the principles of motor learning. Of note, safety concerns were absent. Motor deficits are common and affect quality of life in stroke patients prompting for motor improvement as a top priority. Given the high prevalence and tremendous burden of stroke, a straightforward applicable measure to improve motor outcome is highly relevant. Given the promising but inconclusive clinical trial evidence on benefits, a well-designed, randomized controlled trial studying the usefulness of levodopa in enhancing motor recovery after stroke is warranted.Aim: to study whether levodopa compared to placebo given in addition to standardized rehabilitation based on the principles of motor learning is associated with a patient-relevant enhancement of functional recovery in acute ischemic stroke patients.Design: Multicenter, randomized (ratio 1:1), parallel-group, placebo-controlled superiority trial with blinded patients, care-providers, investigators, and outcome assessors.Patients: Patients with acute ischemic stroke (= 7days) causing clinically meaningful hemiparesis. Eligibility criteria: (i)in-hospital-rehabilitation required and patient capable to participate in standardized rehabilitation therapy; (ii)previous independence in daily living; (iii)absence of indications for dopaminergic agents; (iv)absence of contraindications for levodopa; (v)informed consent.Intervention: Levodopa 100mg/Carbidopa 25mg three times daily, administered for 5 weeks in addition to standardized rehabilitative therapy.Comparison: Matching placebo.Outcome Measures: The primary outcome is the between-group difference of final scores in the Fugl-Meyer-Motor Assessment-(FMA) measured 3 months after randomization. The FMA will also be assessed at the end of study treatment, at 6 and 12 months. Secondary outcomes include patient-reported outcomes, Rivermead Mobility Index, NIH-Stroke Scale score, modified Rankin Scale, Box-and-Block-Test, Jamar dynamometer test, and as measures of harm: mortality, recurrent stroke, and serious adverse events.Main statistical hypothesis: Levodopa administered in addition to standardized rehabilitative therapy is superior to placebo and standardized rehabilitative therapy, resulting in an at least 6 points higher FMA score at 3 months.Sample Size: 610 patients will be recruited. The sample size is estimated to detect a statistically significant and clinically meaningful difference between treatment groups of =6 points in the FMA at 3 months (primary outcome) assuming it is normally distributed with a standard deviation of 25 points (power 80%, two-sided significance level 5%, drop-out-rate 10%).
Thrombolysis in Ischemic Stroke Patients (TRISP): a multicentre research collaboration Research Project | 2 Project MembersTRISP is an open, investigator-driven collaborative research initiative of European stroke centres with expertise in treatment with revascularisation therapies and maintenance of hospital-based registries. All participating centres made a commitment to prospectively collect data on consecutive patients with stroke treated with IVT using standardised definitions of variables and outcomes, to assure accuracy and completeness of the data and to adapt their local databases to answer novel research questions. TRISP aims to address clinically relevant questions about safety and outcomes of intravenous thrombolysis (IVT) and endovascular thrombectomy. The findings can provide observational information on treatment of patients derived from everyday clinical practice.
