Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421337
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-15
Brief Title:
BraiN20 Medical Device in Suspected Acute Stroke Patients
Sponsor:
Alicia Martínez Piñeiro
Organization:
Fundació Institut Germans Trias i Pujol
Study Overview
Official Title:
Somatosensory Evoked Potential SEP N20 Monitoring With BraiN20 Medical Device for Prediction of Functional Independence Defined as Rankin Scale Score 0-2 in Global Patients With Suspected Acute Stroke
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
PROMISE-GLOB
Brief Summary:
Time is Brain company httpwwwtibtimeisbraincomabout_us developed BraiN20 a medical device to assess the presence and characteristics of the N20 signal of SEP Investigators have demonstrated a high prognostic accuracy of N20 on functional recovery of patients with acute ischemic stroke AIS due to large vessel occlusion LVO undergoing endovascular thrombectomy EVT the gold standard treatment The aim if this new project is to validate BraiN20 in global patients presenting with suspected acute ischemic or hemorrhagic stroke in three comprehensive stroke centers in Spain The primary objective is to establish the predictive performance of the presence of the N20 SEP over functional recovery as the primary outcome measure likelihood of having a modified Rankin Scale mRS score 0-2 at 3 months evaluated by blinded independent raters The effect will be measured by the metrics sensitivity specificity and predictive values and compared with clinical and imaging predictive models by Receiving Operating Characteristics ROC curve analysis in the global population stroke subtype and stroke mimics Secondary aims are 1 to determine the area under the curve AUC of the presence of the N20 SEP as biomarker of functional recovery in small subcortical infarctions and in patients with cortical infarctions and no large vessel occlusion 2 to characterize N20 SEP signal in hemorrhagic stroke and stroke mimics and 3 to evaluate the discriminant capacity of an explanatory new algorithm combining pre-hospital clinical variables and N20-SEP signal characteristics between ischemic hemorrhagic and stroke mimics
This project would represent the first pilot study to validate the ability of BraiN20 to predict the functional recovery in the different types of acute stroke but also its ability to discriminate between stroke subtypes Thus BraiN20 monitoring could arise as a paradigm shift in acute stroke management since it would standardize and accelerate patient triage enable real time monitoring increase access to EVT treatment and improve its outcome The trial is sponsored by Time is Brain SL and started in March 2024 Primary endpoint results are expected by the end of the 2024
BraiN20 could be a useful medical device aiding stroke subtype diagnosis and functional recovery
This project would represent the first pilot study to validate the ability of BraiN20 to predict the functional recovery in the different types of acute stroke but also its ability to discriminate between stroke subtypes Thus BraiN20 monitoring could arise as a paradigm shift in acute stroke management since it would standardize and accelerate patient triage enable real time monitoring increase access to EVT treatment and improve its outcome The trial is sponsored by Time is Brain SL and started in March 2024 Primary endpoint results are expected by the end of the 2024
BraiN20 could be a useful medical device aiding stroke subtype diagnosis and functional recovery
Detailed Description:
The likelihood of a favourable outcome of acute stroke is critically dependent on patients presenting promptly after symptom onset and on hospitals providing immediate access to the gold standard treatment the EVT The current clinical stroke management is complex time-consuming requires different hospital settings with specialized equipment and diagnostic is based on momentaneous snapshot providing brain imaging and clinical scores without real-time monitoring tools In addition the current standard of care is unfavourable to patients localized far from a Comprehensive Stroke Center CSC especially for those living in rural regions Thus 50 undergoing EVT do not respond to the treatment because their brain tissue has been already irreversibly damaged
Thus neurologists from the Germans Trias I Pujol CSC Barcelona Spain started a new research line by introducing a new diagnostic approach based on neurophysiological techniques to optimize the selection of patients benefiting from EVT and improve its outcome In 2018 the Somatosensory Evoked Potentials MonItoring During Acute Ischemic Stroke PROMISE clinical trial confirmed in a large cohort n228 that the N20 SEP determined before EVT increases 30 the diagnostic accuracy of salvageable brain compared to the technologies currently used
Time is Brain SL TiB was founded in July 2020 by neurologists from Germans Trias I Pujol CSC to develop BraiN20 a medical device to assess presence and characteristics of N20 SEP signal from AIS onset and during the entire stroke patient journey It promises to be an accurate relatively inexpensive userfriendly device to quickly determine N20 signal of the SEPs This technology is safe and non-invasive and therefore may be especially useful at the pre-hospital stage of stroke patients monitoring brain viability in-hospital and in particular in the angio-room guiding therapeutic strategies
PROMISE20 Somatosensory Evoked Potentials Monitoring in Patients with Acute Ischemic Stroke and Large Anterior Vessel Occlusion Undergoing Endovascular Thrombectomy A Clinical Validation of the BraiN20 Medical Device NCT06149754 is underway
The primary aim is to prove that the percentage of patients with optimal or good reliability of the BraiN20 Medical Device automatic recording of N20 is higher than 75 ie the lower limit of the one-sided 95 confidence interval is higher or equal to 75 assuming a true proportion equal to 875 according to the classification by two expert physicians blind to BraiN20 reading results
While the usefulness of N20 SEP in AIS patients undergoing EVT has already been demonstrated the predictive performance of BraiN20 is unknown in other stroke subtypes and stroke mimics This project aims to validate for the first time BraiN20 monitoring in global patients presenting with suspected acute ischemic or hemorrhagic stroke The accomplishments so far make a strongly believe that BraiN20 will enable a step improvement and become the cornerstone of the acute stroke patient journey
The study will investigate the ability of the BraiN20 medical device to detect and characterize N20 signal in a global population of suspected stroke patients
The primary objective is to establish the predictive performance of the presence of N20 SEP registered by BraiN20 over functional recovery primary outcome likelihood of having a mRS score 0-2 at 90 days evaluated by blinded independent raters The effect will be measure by the metrics sensitivity specificity and predictive values and compared with clinical and imaging predictive models by ROC curve analysis in the global population stroke subtypes and stroke mimics
Secondary aims are
to determine the area under the AUC of the N20 amplitude predicting functional recovery in small subcortical infarctions and in patients with spontaneous LVO revascularization
to characterize N20 signal in intracranial hemorrhage ICH and stroke mimics
to evaluate the discriminant capacity of an explanatory new algorithm combining prehospital clinical variables and N20 signal characteristics between ischemic stroke ICH and stroke mimics
to characterize N20 signal in posterior ischemic strokes and basilar occlusion
Safety outcomes related to BraiN20 monitoring are
Frequency of patients in whom N20 recording prior to treatment disappears after specific treatment such as thrombectomy procedure or surgical treatment
Mortality at day 7
Tolerability of the BraiN20 monitoring
Number of consumables used with mean and standard deviation
PROMISE-GLOB is a prospective interventional single arm multi-center open trial with blinded evaluation of the primary endpoint of a cohort of patients with suspected acute stroke admitted in the emergency department of a CSC The study will be performed in consecutive patients fulfilling eligibility criteria in three comprehensive stroke centers in Spain
Patients will be studied and managed according to local protocols No special recommendations are given but protocols must define criteria for acute medical treatment intravenous thrombolysis endovascular thrombectomy hemicraniectomy and surgical evacuation of ICH Regarding diagnostic tools computed tomography CT CT angiography CTA magnetic resonance MR or MR angiography MRA and ultrasound will be used at discretion of investigators for a required classification of stroke subtype or stroke mimics
SEP monitoring with the BraiN20 medical device will be performed as soon as possible after admission preferably before IV thrombolysis as long as it does not entail a delay in the acute emergency therapies In patients undergoing EVT or surgical therapies baseline SEP monitoring should be performed before these procedures and repeated at the end of them SEP monitoring should also be repeated in case of neurologic deterioration 4 points in the National Institute of Health Stroke Scale NIHSS within the first 24 hours
Patients cohort will be followed up to 90 days after inclusion mRS score will be determined at day 7 or discharge and at day 90 by a local investigator blind to the BraiN20 recordings both face to face or by telephone interview There are no specific study interventions Patients will be discharged at home other centers or admitted at acute stroke units or intensive care units if needed and treated following the European Stroke Organization guidelines
SEP monitoring will be carried out using the BraiN20 medical device and appropriate electrodes SEP of both median nerves will be recorded transferred and stored to the internal card for their evaluation BraiN20 Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral as control to the cerebral hemisphere affected by the stroke and do not require specific training Furthermore the device provides an outcome prediction percentage of likelihood of having mRS 2 day 7 and 90 after stroke onset based on an internal algorithm BraiN20 measures one N20 wave per 33 seconds Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove
SEP recording will be done in the emergency room or in the angiography or surgical room if required Examiners will be physicians or nurses in charge of the patient N20 recordings will be stored in the device for review at the end of the trial It is recommended to obtain three recordings of the N20 response to confirm its presence or absence and exclude a noisy registration in the affected side this takes approximately 3 min Presence of the N20 response in the contralateral side will be used as control to rule out technical issues or the effect of other conditions that could affect the SEPs recordings
At admission at the Emergency Unit patients with suspected acute stroke will be immediately attended by neurologists NIHSS will be evaluated blood will be drawn for baseline analysis and CTCTA neuroimaging performed if indicated by local protocols Anytime during these procedures BraiN20 electrodes will be placed and three N20 recordings obtained from each brain side stroke side and control hemisphere Serum glucose body temperature and blood pressure will be controlled following the American Stroke Association guidelines Alberta Stroke Program Early CT ASPECT score ICH volume AxBxC2 and location will be measured by local investigators on baseline CT Informed consent either oral signed or deferred will be obtained
Stroke subtype will be classified according to the Oxfordshire Community Stroke Project OCSP complemented with neuroimaging findings as total anterior cerebral infarction TACI partial anterior cerebral infarction PACI posterior cerebral infarction POCI and lacunar infarction LACI in addition deep ICH and lobar ICH Stroke etiology following the classification of the Cerebrovascular Diseases Study Group of the Spanish Neurological Society as small vessel disease large artery atherosclerosis extracranial or intracranial atrial fibrillation AF or other cardioembolic diseases Unknown Other ei arterial dissection and stroke mimic
A specific case record form CRF will be generated for each eligible patient The completion of the CRF will be made by authorized site personnel A copy of the CRF will be kept in the hospital records and the original will be collected by the sponsor The investigator must ensure the accuracy completeness and timeliness of data reported in the CRF The sponsor will test all data for completeness consistency and plausibility and produce queries for erroneous incomplete and missing data Any necessary queries will be sent to the investigator by email Periodic monitoring visits will be made by the sponsor throughout the investigation to ensure that the investigators obligations are being fulfilled The database will be keep anonymized and confidentially at the sponsor workplace for centralized monitoring of the electronic records Resolved queries will be returned to the sponsor by email If answers are incomplete or discrepant with other data re-queries may be necessary
No a priori sample size calculation has been done because it is unknown the potential predictive capacity of BraiN20 in a non-selected stroke population This population has not been previously studied and this pilot study aims to establish the proof of concept for a future phase III design The study period is limited to 8-12 months inclusion in three stroke centers and 500 evaluable patients are expected This sample size is appropriate for including more than 100 patients in each stroke subtype Patients that do not fulfil eligibility criteria will be replaced in order to obtain 500 evaluable patients
No risk or benefit for patients is expected in the trial since it is an study without any specific decision-making based on the BraiN20 results Any device malfunction or unexpected characteristics will be registered and the device unit discarded returned to Time is Brain SL for inspection
Thus neurologists from the Germans Trias I Pujol CSC Barcelona Spain started a new research line by introducing a new diagnostic approach based on neurophysiological techniques to optimize the selection of patients benefiting from EVT and improve its outcome In 2018 the Somatosensory Evoked Potentials MonItoring During Acute Ischemic Stroke PROMISE clinical trial confirmed in a large cohort n228 that the N20 SEP determined before EVT increases 30 the diagnostic accuracy of salvageable brain compared to the technologies currently used
Time is Brain SL TiB was founded in July 2020 by neurologists from Germans Trias I Pujol CSC to develop BraiN20 a medical device to assess presence and characteristics of N20 SEP signal from AIS onset and during the entire stroke patient journey It promises to be an accurate relatively inexpensive userfriendly device to quickly determine N20 signal of the SEPs This technology is safe and non-invasive and therefore may be especially useful at the pre-hospital stage of stroke patients monitoring brain viability in-hospital and in particular in the angio-room guiding therapeutic strategies
PROMISE20 Somatosensory Evoked Potentials Monitoring in Patients with Acute Ischemic Stroke and Large Anterior Vessel Occlusion Undergoing Endovascular Thrombectomy A Clinical Validation of the BraiN20 Medical Device NCT06149754 is underway
The primary aim is to prove that the percentage of patients with optimal or good reliability of the BraiN20 Medical Device automatic recording of N20 is higher than 75 ie the lower limit of the one-sided 95 confidence interval is higher or equal to 75 assuming a true proportion equal to 875 according to the classification by two expert physicians blind to BraiN20 reading results
While the usefulness of N20 SEP in AIS patients undergoing EVT has already been demonstrated the predictive performance of BraiN20 is unknown in other stroke subtypes and stroke mimics This project aims to validate for the first time BraiN20 monitoring in global patients presenting with suspected acute ischemic or hemorrhagic stroke The accomplishments so far make a strongly believe that BraiN20 will enable a step improvement and become the cornerstone of the acute stroke patient journey
The study will investigate the ability of the BraiN20 medical device to detect and characterize N20 signal in a global population of suspected stroke patients
The primary objective is to establish the predictive performance of the presence of N20 SEP registered by BraiN20 over functional recovery primary outcome likelihood of having a mRS score 0-2 at 90 days evaluated by blinded independent raters The effect will be measure by the metrics sensitivity specificity and predictive values and compared with clinical and imaging predictive models by ROC curve analysis in the global population stroke subtypes and stroke mimics
Secondary aims are
to determine the area under the AUC of the N20 amplitude predicting functional recovery in small subcortical infarctions and in patients with spontaneous LVO revascularization
to characterize N20 signal in intracranial hemorrhage ICH and stroke mimics
to evaluate the discriminant capacity of an explanatory new algorithm combining prehospital clinical variables and N20 signal characteristics between ischemic stroke ICH and stroke mimics
to characterize N20 signal in posterior ischemic strokes and basilar occlusion
Safety outcomes related to BraiN20 monitoring are
Frequency of patients in whom N20 recording prior to treatment disappears after specific treatment such as thrombectomy procedure or surgical treatment
Mortality at day 7
Tolerability of the BraiN20 monitoring
Number of consumables used with mean and standard deviation
PROMISE-GLOB is a prospective interventional single arm multi-center open trial with blinded evaluation of the primary endpoint of a cohort of patients with suspected acute stroke admitted in the emergency department of a CSC The study will be performed in consecutive patients fulfilling eligibility criteria in three comprehensive stroke centers in Spain
Patients will be studied and managed according to local protocols No special recommendations are given but protocols must define criteria for acute medical treatment intravenous thrombolysis endovascular thrombectomy hemicraniectomy and surgical evacuation of ICH Regarding diagnostic tools computed tomography CT CT angiography CTA magnetic resonance MR or MR angiography MRA and ultrasound will be used at discretion of investigators for a required classification of stroke subtype or stroke mimics
SEP monitoring with the BraiN20 medical device will be performed as soon as possible after admission preferably before IV thrombolysis as long as it does not entail a delay in the acute emergency therapies In patients undergoing EVT or surgical therapies baseline SEP monitoring should be performed before these procedures and repeated at the end of them SEP monitoring should also be repeated in case of neurologic deterioration 4 points in the National Institute of Health Stroke Scale NIHSS within the first 24 hours
Patients cohort will be followed up to 90 days after inclusion mRS score will be determined at day 7 or discharge and at day 90 by a local investigator blind to the BraiN20 recordings both face to face or by telephone interview There are no specific study interventions Patients will be discharged at home other centers or admitted at acute stroke units or intensive care units if needed and treated following the European Stroke Organization guidelines
SEP monitoring will be carried out using the BraiN20 medical device and appropriate electrodes SEP of both median nerves will be recorded transferred and stored to the internal card for their evaluation BraiN20 Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral as control to the cerebral hemisphere affected by the stroke and do not require specific training Furthermore the device provides an outcome prediction percentage of likelihood of having mRS 2 day 7 and 90 after stroke onset based on an internal algorithm BraiN20 measures one N20 wave per 33 seconds Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove
SEP recording will be done in the emergency room or in the angiography or surgical room if required Examiners will be physicians or nurses in charge of the patient N20 recordings will be stored in the device for review at the end of the trial It is recommended to obtain three recordings of the N20 response to confirm its presence or absence and exclude a noisy registration in the affected side this takes approximately 3 min Presence of the N20 response in the contralateral side will be used as control to rule out technical issues or the effect of other conditions that could affect the SEPs recordings
At admission at the Emergency Unit patients with suspected acute stroke will be immediately attended by neurologists NIHSS will be evaluated blood will be drawn for baseline analysis and CTCTA neuroimaging performed if indicated by local protocols Anytime during these procedures BraiN20 electrodes will be placed and three N20 recordings obtained from each brain side stroke side and control hemisphere Serum glucose body temperature and blood pressure will be controlled following the American Stroke Association guidelines Alberta Stroke Program Early CT ASPECT score ICH volume AxBxC2 and location will be measured by local investigators on baseline CT Informed consent either oral signed or deferred will be obtained
Stroke subtype will be classified according to the Oxfordshire Community Stroke Project OCSP complemented with neuroimaging findings as total anterior cerebral infarction TACI partial anterior cerebral infarction PACI posterior cerebral infarction POCI and lacunar infarction LACI in addition deep ICH and lobar ICH Stroke etiology following the classification of the Cerebrovascular Diseases Study Group of the Spanish Neurological Society as small vessel disease large artery atherosclerosis extracranial or intracranial atrial fibrillation AF or other cardioembolic diseases Unknown Other ei arterial dissection and stroke mimic
A specific case record form CRF will be generated for each eligible patient The completion of the CRF will be made by authorized site personnel A copy of the CRF will be kept in the hospital records and the original will be collected by the sponsor The investigator must ensure the accuracy completeness and timeliness of data reported in the CRF The sponsor will test all data for completeness consistency and plausibility and produce queries for erroneous incomplete and missing data Any necessary queries will be sent to the investigator by email Periodic monitoring visits will be made by the sponsor throughout the investigation to ensure that the investigators obligations are being fulfilled The database will be keep anonymized and confidentially at the sponsor workplace for centralized monitoring of the electronic records Resolved queries will be returned to the sponsor by email If answers are incomplete or discrepant with other data re-queries may be necessary
No a priori sample size calculation has been done because it is unknown the potential predictive capacity of BraiN20 in a non-selected stroke population This population has not been previously studied and this pilot study aims to establish the proof of concept for a future phase III design The study period is limited to 8-12 months inclusion in three stroke centers and 500 evaluable patients are expected This sample size is appropriate for including more than 100 patients in each stroke subtype Patients that do not fulfil eligibility criteria will be replaced in order to obtain 500 evaluable patients
No risk or benefit for patients is expected in the trial since it is an study without any specific decision-making based on the BraiN20 results Any device malfunction or unexpected characteristics will be registered and the device unit discarded returned to Time is Brain SL for inspection
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