Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03699397
Status:
UNKNOWN
Last Update Posted:
2022-06-09
First Post:
2018-10-03
Brief Title:
EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELECTRA-STROKE
Brief Summary:
Endovascular thrombectomy EVT is the standard treatment for patients with a large vessel occlusion LVO stroke Direct presentation of patients with an LVO to a comprehensive stroke center CSC reduces onset-to-treatment time by approximately an hour and thereby improves clinical outcome However a reliable tool for prehospital LVO-detection is currently not available Previous electroencephalography EEG studies have shown that hemispheric hypoxia quickly results in slowing of the EEG-signal Dry electrode EEG caps allow reliable EEG measurement in less than five minutes We hypothesize that dry electrode EEG is an accurate and feasible diagnostic test for LVO in the prehospital setting
ELECTRA-STROKE is a diagnostic pilot study that consists of four phases In phases 1 2 and 3 technical and logistical feasibility of performing dry electrode EEGs are tested in different in-hospital settings the outpatient clinic sample size max 20 patients Neurology ward sample size max 20 patients and emergency room sample size max 300 patients respectively In the final phase ambulance paramedics will perform dry electrode EEGs in 386 patients with a suspected stroke The aim of the ELECTRA-STROKE study is to determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS Sample size calculation is based on an expected specificity of 70 and an incidence of LVO stroke of 5
ELECTRA-STROKE is a diagnostic pilot study that consists of four phases In phases 1 2 and 3 technical and logistical feasibility of performing dry electrode EEGs are tested in different in-hospital settings the outpatient clinic sample size max 20 patients Neurology ward sample size max 20 patients and emergency room sample size max 300 patients respectively In the final phase ambulance paramedics will perform dry electrode EEGs in 386 patients with a suspected stroke The aim of the ELECTRA-STROKE study is to determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS Sample size calculation is based on an expected specificity of 70 and an incidence of LVO stroke of 5
Detailed Description:
RATIONALE
Endovascular thrombectomy EVT is standard treatment for acute ischemic stroke AIS if there is a large vessel occlusion in the anterior circulation LVO-a Because of its complexity EVT is performed in selected hospitals only Currently approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy This delays initiation of treatment by approximately an hour which decreases the chance of a good clinical outcome Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible since only approximately 7 of these patients are eligible for EVT Therefore an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary Electroencephalography EEG may be suitable for this purpose as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with wet EEGs Combined with algorithms for automated signal analysis we expect the time of EEG recording and analysis to eventually be below five minutes which would make stroke triage in the ambulance by EEG logistically feasible
HYPOTHESIS
We hypothesize that EEG accurately identifies the presence of an LVO-a stroke in patients with a suspected AIS when applied in the ambulance
OBJECTIVE
To determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS
STUDY DESIGN
This diagnostic study consists of four phases
Phase 1 Optimization of measurement time and software settings of the dry electrode cap EEG in a non-emergency setting in patients in whom a regular EEG iswill be performed for standard medical care Sample size maximum of 20 patients
Phase 2 Optimization of measurement time and software settings of the dry electrode cap EEG in patients close to our target population in a non-emergency setting Sample size maximum of 20 patients
Phase 3 Validation of several existing algorithms and development of one or more new algorithms for LVO-a detection as well as optimization of logistics and software settings of the dry electrode EEG cap in patients close to our target population in an in-hospital emergency setting Sample size maximum of 300 patients
Phase 4 Validation of several existing algorithms and algorithms developed in phase 3 for LVO-a detection in patients with a suspected AIS in the ambulance as well as assessment of technical and logistical feasibility of performing EEG with dry electrode caps in patients with a suspected AIS in the ambulance Sample size maximum of 386 patients
STUDY POPULATION
Phase 1 Patients in the outpatient clinic of the Clinical Neurophysiology department of the AMC in whom a regular EEG has beenwill be performed for standard medical care
Phase 2 Patients with an AIS admitted to the Neurology ward of the coordinating hospital with an LVO-a after reperfusion therapy
Phase 3 Patients with a suspected AIS in the emergency room ER of the coordinating hospital before endovascular treatment
Phase 4 Patients with a suspected AIS in the ambulance
INTERVENTION
Performing a dry electrode cap EEG in phase 1 in the outpatient clinic in phase 2 during hospital admission in phase 3 in the ER and in phase 4 in the ambulance
MAIN END POINTS
Primary end point the diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting study phase 4 expressed as the area under the receiver operating characteristics ROC curve of the thetaalpha ratio
Secondary end points
Sensitivity specificity PPV and NPV of the thetaalpha ratio and test characteristics of other existing EEG data based algorithms for LVO-a detection eg Weighted Phase Lag Index deltaalpha ratio
Logistical and technical feasibility of paramedics performing dry electrode cap EEG in the ambulance in suspected AIS patients
Developing one or more novel EEG data based algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG
Endovascular thrombectomy EVT is standard treatment for acute ischemic stroke AIS if there is a large vessel occlusion in the anterior circulation LVO-a Because of its complexity EVT is performed in selected hospitals only Currently approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy This delays initiation of treatment by approximately an hour which decreases the chance of a good clinical outcome Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible since only approximately 7 of these patients are eligible for EVT Therefore an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary Electroencephalography EEG may be suitable for this purpose as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with wet EEGs Combined with algorithms for automated signal analysis we expect the time of EEG recording and analysis to eventually be below five minutes which would make stroke triage in the ambulance by EEG logistically feasible
HYPOTHESIS
We hypothesize that EEG accurately identifies the presence of an LVO-a stroke in patients with a suspected AIS when applied in the ambulance
OBJECTIVE
To determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS
STUDY DESIGN
This diagnostic study consists of four phases
Phase 1 Optimization of measurement time and software settings of the dry electrode cap EEG in a non-emergency setting in patients in whom a regular EEG iswill be performed for standard medical care Sample size maximum of 20 patients
Phase 2 Optimization of measurement time and software settings of the dry electrode cap EEG in patients close to our target population in a non-emergency setting Sample size maximum of 20 patients
Phase 3 Validation of several existing algorithms and development of one or more new algorithms for LVO-a detection as well as optimization of logistics and software settings of the dry electrode EEG cap in patients close to our target population in an in-hospital emergency setting Sample size maximum of 300 patients
Phase 4 Validation of several existing algorithms and algorithms developed in phase 3 for LVO-a detection in patients with a suspected AIS in the ambulance as well as assessment of technical and logistical feasibility of performing EEG with dry electrode caps in patients with a suspected AIS in the ambulance Sample size maximum of 386 patients
STUDY POPULATION
Phase 1 Patients in the outpatient clinic of the Clinical Neurophysiology department of the AMC in whom a regular EEG has beenwill be performed for standard medical care
Phase 2 Patients with an AIS admitted to the Neurology ward of the coordinating hospital with an LVO-a after reperfusion therapy
Phase 3 Patients with a suspected AIS in the emergency room ER of the coordinating hospital before endovascular treatment
Phase 4 Patients with a suspected AIS in the ambulance
INTERVENTION
Performing a dry electrode cap EEG in phase 1 in the outpatient clinic in phase 2 during hospital admission in phase 3 in the ER and in phase 4 in the ambulance
MAIN END POINTS
Primary end point the diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting study phase 4 expressed as the area under the receiver operating characteristics ROC curve of the thetaalpha ratio
Secondary end points
Sensitivity specificity PPV and NPV of the thetaalpha ratio and test characteristics of other existing EEG data based algorithms for LVO-a detection eg Weighted Phase Lag Index deltaalpha ratio
Logistical and technical feasibility of paramedics performing dry electrode cap EEG in the ambulance in suspected AIS patients
Developing one or more novel EEG data based algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None