BraiN20® Medical Device in Suspected Acute Stroke Patients

NCT06421337 | Recruiting

• 1 other identifier: PROMISE GLOBAL CIP V2.0
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

Time is Brain company (http://www.tibtimeisbrain.com/about\_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 S.L. 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.

Conditions

Acute Stroke

Keywords

Somatosensory evoked potentials; Acute stroke ischemic; Acute stroke hemorrhagic; Stroke mimics; Prognosis; Functional recovery; Medical device; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Functional recovery at 3 months

  Functional recovery is defined by modified Rankin Scale score 0-2 (min 0, no disability; max 6, death) at day 90 after stroke. Modified Rankin Scale score will be measured by blinded local raters according to a structured interview at day 7 or before discharge and at day 90 by telephone interview or face to face. Two cohort groups are defined: Stroke functional recovery: mRS lower or equal than 2 at 90 ± 15 days. Stroke functional dependence: mRS higher than 2 at 90 ± 15 days.

  Day 90

Secondary Outcomes (2)

• N20 signal characteristics

  At admission within 24 hours from stroke onset

• National Institute of Health Stroke Scale score (NIHSS)

  Days 7 and 90

Other Outcomes (1)

• Tolerability of the BraiN20® monitoring

  At admission within 24 hours from stroke onset

Study Arms (1)

Study group

EXPERIMENTAL

Subjects presenting at emergency departments of participating hospitals with suspected acute stroke within 24 hours from symptom onset with or without stroke code activation

Device: BraiN20(R)

Interventions

BraiN20(R) DEVICE

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.

Study group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected acute stroke ischemic or hemorrhagic admitted in the emergency department within 24 hours from symptoms onset or from the last time seen normal.
• Stroke mimics classified after neurologic examination and diagnostic procedures will be also included.
• Age ≥18.
• No significant pre-stroke functional dependence (mRS ≤ 2).
• Baseline NIHSS score obtained prior to procedure must be equal or higher than 1 point. Patients with TIA and full recovery on admission must not be included.
• Patients in whom BraiN20® monitoring can be performed without delay of acute stroke therapies.
• Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the stroke emergency therapies.

You may not qualify if:

• \- Clinical criteria
• Serious, advanced, or terminal illness with an anticipated life expectancy of less than three months.
• Women in the premenopausal period.
• \- Neuroimaging criteria
• 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 lesions in the area where electrical stimulation is to 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, vein puncture).

Sponsors & Collaborators

• Alicia Martínez Piñeiro: lead

Study Sites (3)

Hospital Universitari de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, 28006, Spain

RECRUITING

Related Publications (3)

• 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

  BACKGROUND

• Pittock SJ, Meldrum D, Hardiman O, Thornton J, Brennan P, Moroney JT. The Oxfordshire Community Stroke Project classification: correlation with imaging, associated complications, and prediction of outcome in acute ischemic stroke. J Stroke Cerebrovasc Dis. 2003 Jan;12(1):1-7. doi: 10.1053/jscd.2003.7.

  PMID: 17903897 BACKGROUND

• Sobrino Garcia P, Garcia Pastor A, Garcia Arratibel A, Vicente Peracho G, Rodriguez Cruz PM, Perez Sanchez JR, Diaz Otero F, Vazquez Alen P, Villanueva Osorio JA, Gil Nunez A. [Aetiological classification of ischaemic strokes: comparison of the new A-S-C-O classification and the classification by the Spanish Society of Neurology's Cerebrovascular Disease Study Group]. Neurologia. 2013 Sep;28(7):417-24. doi: 10.1016/j.nrl.2012.07.005. Epub 2012 Sep 19. Spanish.

  PMID: 22998938 BACKGROUND

Related Links

• Startup developing BraiN20(R)

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, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Alicia Martinez, MD, PhD

CONTACT

+34662121408; aliciamp@tibtimeisbrain.com

Antoni Dávalos, MD, PhD

CONTACT

+34616968690; antonide@tibtimeisbrain.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome will be evaluated by an independent assessor blinded to the monitoring results at the acute phase
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 20, 2024
• Study Start: March 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)