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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Functional recovery at 3 months
研究概览
简要总结
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.
详细描述
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 (n=228) that the N20 SEP determined before EVT increases 30% the diagnostic accuracy of salvageable brain compared to the technologies currently used.
Time is Brain S.L. (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% (i.e., the lower limit of the one-sided 95% confidence interval is higher or equal to 75%), assuming a true proportion equal to 87.5%, according to the classification by two expert physicians blind to BraiN20® reading results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Outcome will be evaluated by an independent assessor blinded to the monitoring results at the acute phase
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Participation in other treatment or diagnostic test clinical trial is allowed if the patients fulfill the inclusion criteria of PROMISE-GLOBAL.
- •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.
排除标准
- •- Clinical criteria
- •Patients with a well-documented history of neuromuscular diseases and other severe neurodegenerative disorders (Mild Cognitive Impairment is not exclusion criteria), prior stroke (TIA is not exclusion criteria) or nervous system tumors that could interfere with SEP assessment.
- •Serious, advanced, or terminal illness with an anticipated life expectancy of less than three months.
- •Women in the premenopausal period.
- •- Neuroimaging criteria
- •Acute infarct volume (ASPECTS) or ICH volume (AxBxC/2) on plane CT should be measured but they are not exclusion criteria and should not preclude any specific treatment according to local protocols (i.e., mechanical thrombectomy, hemicraniectomy or ICH evacuation).
- •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).
研究组 & 干预措施
Study group
Subjects presenting at emergency departments of participating hospitals with suspected acute stroke within 24 hours from symptom onset with or without stroke code activation
干预措施: BraiN20(R) (Device)
结局指标
主要结局
Functional recovery at 3 months
时间窗: Day 90
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.
次要结局
- N20 signal characteristics(At admission within 24 hours from stroke onset)
- National Institute of Health Stroke Scale score (NIHSS)(Days 7 and 90)
研究者
Alicia Martínez Piñeiro
Principal Investigator
Fundació Institut Germans Trias i Pujol