BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy

NCT06149754 | Unknown DMC

• 1 other identifier: PROMISE20 V1.2, July 07 2023
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

N20 somatosensory evoked potential (SEP) response shows high predictive accuracy of functional recovery in patients with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT). This capacity is independent and even higher than clinical and advanced imaging variables. This study aims to validate BraiN20®, a portable, non-invasive, automatic device to monitor in real-time the presence and characteristics of N20 in AIS patients. 65 patients with AIS and anterior LVO undergoing EVT within 24 hours from onset will be included in three comprehensive stroke centers of Catalonia, Spain. Eligibility criteria are no significant pre-stroke functional dependence, baseline National of Institute of Health Stroke Scale (NIHSS) score equal or higher than 6 points, occlusion (modified Thrombolysis in Cerebral Infarction, (mTICI) 0-1) of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 suitable for EVT per local protocols, without infarct volume restrictions measured by Alberta Stroke Program Early CT (ASPECT) score or by Perfusion Computed Tomography (PCT)/Diffusion Weighted Imaging-Magnetic Resonance Imaging(DWI-MRI) prior to EVT . The primary objective is to confirm an optimal/good reliability of N20 registration before EVT higher than 75% by two blind expert neurophysiologists, assuming a true proportion equal to 87.5%. Secondary endpoints are the predictive accuracy of N20 response recorded by BraiN20® before and after EVT on functional outcome evaluated by the mRS at 7 and 90 days and analyzed by using Receiving Operating Characteristic curves (ROC). A futility interim analysis is planned after the inclusion of 25% population. The trial is sponsored by Time is Brain S.L. and started in September 2023. Primary endpoint results are expected for the first quarter of 2024. BraiN20® could be a useful medical device to predict salvageable brain and functional recovery of patients along the stroke chain.

Conditions

Acute Stroke; Mechanical Thrombectomy

Keywords

Evoked potentials, Somatosensory; Acute ischemic stroke; Mechanical Thrombectomy; Prognosis; Salvageable brain; Functional recovery; Medical device; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Reliability of the BraiN20® Medical Device

  Percentage of patients with optimal or good reliability of the automatic recording of N20 response by the BraiN20® Medical Device according to the classification of two expert physicians blind to BraiN20® reading results. The goal is to be equal or higher than 75%

  Prior to mechanical thrombectomy and at the end of the procedure

Secondary Outcomes (1)

• Predictive capacity of functional recovery

  Day 7 after thrombectomy

Other Outcomes (4)

• Predictive capacity of functional recovery at the end of follow-up

  90 days

• Rate of presence of N20 response by subgroups

  Baseline

• Rate of presence of N20 response by dramatic neurologic improvement

  24 hours

Study Arms (1)

Acute ischemic stroke with large vessel occlusion

Patients between 18 and 85 years old who have and acute cerebral stroke due to a demonstrated occlusion in the anterior circulation (M1 or M2 segment of middle cerebral artery with or without ipsilateral internal carotid artery (ICA), that undergo endovascular acute therapy fulfilling all inclusion criteria and with non exclusion criteria for that treatment. We also exclude patient with well-documented history of neuromuscular disorders, stroke or central nervous system tumors that could interfere in the SEPs assessment.

Device: BraiN20(R) monitoring of N20 somatosensory evoked potential

Interventions

BraiN20(R) monitoring of N20 somatosensory evoked potential DEVICE

N20 monitoring will be carried out using the BraiN20 medical device and appropriate electrodes. The device measures one N20 wave per 33 seconds. Scalp electrodes will be located on band and wrist electrodes on a globe. The device provides an automatic reading of N20 and outcome prediction and do not require a specific training.

Acute ischemic stroke with large vessel occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The PROMISE20 study will be performed in consecutive patients fulfilling eligibility criteria admitted because of severe acute ischemic stroke in three comprehensive stroke centers in Catalonia, Spain: * Neuroscience department, Hospital Germans Trias i Pujol, Badalona, Barcelona * Services of Neurology and Interventional Neuroradiology, Hospital Vall d'Hebron, Barcelona * Services of Neurology and Interventional Neuroradiology, Hospital Josep Trueta, Girona

You may qualify if:

• Acute ischemic stroke with large anterior vessel occlusion undergoing treatment with EVT according to local protocols.
• Age ≥18.
• No significant pre-stroke functional dependence (mRS ≤ 2).
• Patient treatable within 24 hours of symptom onset. Symptoms onset is defined as the time the patient was last seen well, and treatment point as the time of arterial puncture.
• Baseline NIHSS score obtained prior to procedure must be equal or higher than 6 points.
• Occlusion (mTICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA M1 segment or M2 suitable for EVT, as evidenced by CTA or MRA with or without concomitant cervical carotid occlusion or stenosis.
• Any infarct core, without volume restrictions, measured by ASPECT score or by PCT/DWI-MRI prior to EVT.
• Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the mechanical thrombectomy.

You may not qualify if:

• Clinical criteria
• Patients with a well-documented history of neuromuscular diseases and other neurodegenerative disorders, prior stroke (TIA not excluded) or nervous system tumors that could interfere with SEP assessment.
• Serious, advanced, or terminal illness with anticipated life expectancy of less than three months.
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
• Known pregnant women. In case of women of childbearing potential (WOCBP) with no highly effective methods for birth control, a pregnancy test should be performed.
• Neuroimaging criteria
• CT or MR evidence of hemorrhage (the presence of microbleeds is allowed).
• Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
• Evidence of intracranial tumor (except small meningioma).
• BraiN20® medical device safety issues:
• Subjects with a demand-type cardiac pacemaker, defibrillator, or other electrical implant or metal.
• Patients with suspected or well-known cancerous skin lesion in the area where electrical stimulation will be applied.
• Patients who have a localized disorder in the wrist and forearm where electrical stimulation is to be applied (i.e., fractures or dislocations).

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• European Innovation Council: collaborator
• Anagram-ESIC: collaborator

Study Sites (3)

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

RECRUITING

Hospital Universitario Vall d'Hebrón

Barcelona, Spain

RECRUITING

Hospital Universitario Doctor Josep Trueta

Girona, Spain

NOT YET RECRUITING

Related Publications (14)

• From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

  PMID: 29786478 BACKGROUND

• Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

  PMID: 26898852 BACKGROUND

• Venema E, Roozenbeek B, Mulder MJHL, Brown S, Majoie CBLM, Steyerberg EW, Demchuk AM, Muir KW, Davalos A, Mitchell PJ, Bracard S, Berkhemer OA, Lycklama A Nijeholt GJ, van Oostenbrugge RJ, Roos YBWEM, van Zwam WH, van der Lugt A, Hill MD, White P, Campbell BCV, Guillemin F, Saver JL, Jovin TG, Goyal M, Dippel DWJ, Lingsma HF; HERMES collaborators and MR CLEAN Registry Investigators*. Prediction of Outcome and Endovascular Treatment Benefit: Validation and Update of the MR PREDICTS Decision Tool. Stroke. 2021 Aug;52(9):2764-2772. doi: 10.1161/STROKEAHA.120.032935. Epub 2021 Jul 16.

  PMID: 34266308 BACKGROUND

• Bourcier R, Goyal M, Muir KW, Desal H, Dippel DWJ, Majoie CBLM, van Zwam WH, Jovin TG, Mitchell PJ, Demchuk AM, van Oostenbrugge RJ, Brown SB, Campbell B, White P, Hill MD, Saver JL, Weimar C, Jahan R, Guillemin F, Bracard S, Naggara O; HERMES Trialists Collaboration. Risk factors of unexplained early neurological deterioration after treatment for ischemic stroke due to large vessel occlusion: a post hoc analysis of the HERMES study. J Neurointerv Surg. 2023 Mar;15(3):221-226. doi: 10.1136/neurintsurg-2021-018214. Epub 2022 Feb 15.

  PMID: 35169030 BACKGROUND

• van de Graaf RA, Samuels N, Chalos V, Lycklama A Nijeholt GJ, van Beusekom H, Yoo AJ, van Zwam WH, Majoie CBLM, Roos YBWEM, van Doormaal PJ, Ben Hassen W, van der Lugt A, Dippel DWJ, Lingsma HF, van Es ACGM, Roozenbeek B; MR CLEAN Registry investigators. Predictors of poor outcome despite successful endovascular treatment for ischemic stroke: results from the MR CLEAN Registry. J Neurointerv Surg. 2022 Jul;14(7):660-665. doi: 10.1136/neurintsurg-2021-017726. Epub 2021 Jul 15.

  PMID: 34266905 BACKGROUND

• Li H, Huang J, Ye S, Chen H, Yuan L, Liao G, Du W, Li C, Fang L, Liu S, Yang P, Zhang Y, Xing P, Zhang X, Ye X, Peng Y, Cao J, Zhang L, Yang Z, Liu J; DIRECT-MT investigators. Predictors of mortality in acute ischemic stroke treated with endovascular thrombectomy despite successful reperfusion: subgroup analysis of a multicentre randomised clinical trial. BMJ Open. 2022 Mar 1;12(3):e053765. doi: 10.1136/bmjopen-2021-053765.

  PMID: 35232782 BACKGROUND

• Lansberg MG, Mlynash M, Hamilton S, Yeatts SD, Christensen S, Kemp S, Lavori PW, Ortega-Gutierrez S, Broderick J, Heit J, Marks MP, Albers GW; DEFUSE 3 Investigators. Association of Thrombectomy With Stroke Outcomes Among Patient Subgroups: Secondary Analyses of the DEFUSE 3 Randomized Clinical Trial. JAMA Neurol. 2019 Apr 1;76(4):447-453. doi: 10.1001/jamaneurol.2018.4587.

  PMID: 30688974 BACKGROUND

• Bhuva P, Yoo AJ, Jadhav AP, Jovin TG, Haussen DC, Bonafe A, Budzik RJ, Yavagal DR, Hanel RA, Hassan AE, Ribo M, Cognard C, Sila CA, Morgan PM, Zhang Y, Shields R, Smith W, Saver JL, Liebeskind DS, Nogueira RG; DAWN Trial Investigators. Noncontrast Computed Tomography Alberta Stroke Program Early CT Score May Modify Intra-Arterial Treatment Effect in DAWN. Stroke. 2019 Sep;50(9):2404-2412. doi: 10.1161/STROKEAHA.118.024583. Epub 2019 Jul 26.

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• Campbell BCV, Majoie CBLM, Albers GW, Menon BK, Yassi N, Sharma G, van Zwam WH, van Oostenbrugge RJ, Demchuk AM, Guillemin F, White P, Davalos A, van der Lugt A, Butcher KS, Cherifi A, Marquering HA, Cloud G, Macho Fernandez JM, Madigan J, Oppenheim C, Donnan GA, Roos YBWEM, Shankar J, Lingsma H, Bonafe A, Raoult H, Hernandez-Perez M, Bharatha A, Jahan R, Jansen O, Richard S, Levy EI, Berkhemer OA, Soudant M, Aja L, Davis SM, Krings T, Tisserand M, San Roman L, Tomasello A, Beumer D, Brown S, Liebeskind DS, Bracard S, Muir KW, Dippel DWJ, Goyal M, Saver JL, Jovin TG, Hill MD, Mitchell PJ; HERMES collaborators. Penumbral imaging and functional outcome in patients with anterior circulation ischaemic stroke treated with endovascular thrombectomy versus medical therapy: a meta-analysis of individual patient-level data. Lancet Neurol. 2019 Jan;18(1):46-55. doi: 10.1016/S1474-4422(18)30314-4. Epub 2018 Nov 6.

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  PMID: 15030797 BACKGROUND

• Alicia Martinez-Piñeiro MD, PhD aliciamp@tibtimeisbrain.com , Giuseppe Lucente MD, PhD , María Hernandez-Perez MD, PhD , Jordi Cortés PhD , Andrea Arbex MD , Natalia Pérez de la Ossa MD, PhD , Alba Ramos-Fransí MD, PhD , Miriam Almendrote MD , Mònica Millán MD, PhD , Meritxell Gomis MD, PhD , Laura Dorado MD, PhD , Carlos Castaño MD, PhD , Sebastián Remollo MD , Patricia Cuadras MD, PhD , Alicia Garrido MD , Nicolau Guanyabens MD , Joaquim Broto MD , Elena López-Cancio MD, PhD , Jaume Coll-Canti MD, PhD , Antoni Dávalos MD, PhD , and PROMISE (Somatosensory Evoked POtEntials MonItoring During Acute Ischemic StrokE) Study Group. Prognostic Accuracy of N20 Somatosensory Potential in Patients With Acute Ischemic Stroke and Endovascular Thrombectomy. Stroke: Vascular and Interventional Neurology. 2023 | Volume 3, Issue 5: e000735

  RESULT

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoni Dávalos, Prof. MD.PhD

  Fundació Institut d'Investigació en Ciències de la Salut Germans Trias iPujol

  STUDY CHAIR

Central Study Contacts

Alicia Martinez-Piñeiro, MD, PhD

CONTACT

0034662121408; amartinezp.germanstrias@gencat.cat

Antoni Dávalos, Prof.MD.PhD

CONTACT

0034616968690; adavalos.germanstrias@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 29, 2023
• Study Start: September 15, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)