PROMISE (Somatosensory Evoked POtEntials MonItoring During Acute Ischemic StrokE) Study

NCT04099615 | Completed

• 1 other identifier: 201708.10
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular treatment in patients with acute ischemic stroke due to large vessel occlusion does not always lead to good clinical and functional outcome, despite achieving complete arterial recanalization. The rate of significant functional disability or death after three months of an acute ischemic stroke still ranges from 40% to 67%. There is experimental and clinical evidence that somatosensory evoked potentials (SEPs) are good indicators of cerebral blood flow. The primary objective of this study is to determine the sensitivity and specificity of N20 response of SEPs prior to mechanical thrombectomy (MT) as a predictor of functional independence at 90 days after endovascular treatment. Secondly, the investigators will study whether SEPs may be neurophysiological markers of brain tissue in ischemic penumbra and optimal collateral circulation. Bilateral median nerve SEPs will be recorded before and continuously during MT in patients with acute ischemic stroke and anterior large vessel occlusion. N20 response ipsilateral to the cerebral hemisphere affected will be measured (qualitatively and quantitatively). The adjusted predictive value of the N20 biomarker on functional independence after MT will be analyzed by binary logistic regression and its predictive value on the full range of disability by ordinal logistic regression. The investigators will construct different regression models with other clinical predictors available at the prehospital setting and with those determined after hospital admission to determine the independent predictive power of the N20 response for a potential treatment decision-making. Finally, the investigators will study whether SEP can be neurophysiological markers ischemic penumbra tissue and optimal collateral circulation through its correlation with multimodal neuroimaging techniques. SEPs recording is non-invasive technique that can be performed at the bedside of the patient. The development of a portable device which could allow SEPs recording by sanitary staff (pre- and intrahospitally) would provide early data about N20 value, speeding up streamline decision making.

Conditions

Acute Cerebrovascular Accident; Endovascular Procedures

Keywords

Evoked Potentials, Somatosensory; Acute Cerebrovascular Accident; Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

• Functional independence at 7 days or discharge

  The primary outcome is the functional independence at 7 days or discharge, defined by the modified Rankin scale score 0- 2. This early and more feasible outcome has a very high correlation with functional dependence at 90 days (Davalos A et al. Lancet Neurol 2017). Local certified assessors who are unaware of the SEPs monitoring findings evaluate the primary outcome variable in each patient by means of a structured interview.

  Baseline to 7 days or the day of discharge from hospital if it happens before the 7th day

Secondary Outcomes (8)

• Functional independence at 90 days from the stroke

  Baseline to 90 days

• Early dramatic response to treatment

  Baseline to 24 hours

• Neurologic improvement

  Baseline to 24 hours

• Clinical status

  Baseline to 7 days or the day of discharge from hospital if it happens before the 7th day

• Infarct volume at 24 hours

  Baseline to 24 hours

Study Arms (1)

Endovascular urgent stroke treatment group

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.

Procedure: Somatosensory Evoked Potentials

Interventions

Somatosensory Evoked Potentials PROCEDURE

We stimulate both median nerves at wrist by means of surface adhesive electrodes. We apply square wave electrical pulses of 0.2 ms duration at a frequency of 5.7Hz. SEPs are recorded in a referential fashion from the C3' and C4' positions and from a reference electrode at Fpz or Cz' electrodes(international 10-20 system) with needle electrodes. The target signal is the presence of N20 response ipsilateral to the stroke site and, if present, measure amplitude and latency comparing with the contralateral if present. SEPs are registered during the whole procedure.

Also known as: SEP

Endovascular urgent stroke treatment group

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

Patients from our influence area (Barcelones-Nord-Maresme) ,other parts of Catalonia or people in this area at the moment of the acute stroke, arriving to our hospital because of an acute stroke of the anterior brain circulation, fulfilling criteria of endovascular urgent therapy

You may qualify if:

• Acute stroke with a demonstrated occlusion in the anterior circulation (M1 or M2 segment of middle cerebral artery with or without ipsilateral internal carotid artery (ICA)significant stenosis or occlusion diagnosed by CT angiography (CTA) or angio-MRI) undergoing urgent thrombectomy procedure.
• Prestroke functional independence of 2 or less on the modified Rankin scale (ranging from 0 \[no symptoms\] to 6 \[death\]),
• Baseline score of at least 6 points on the National Institutes of Health Stroke Scale (NIHSS), which ranges from 0 to 42, with higher values indicating more severe deficit.

You may not qualify if:

• Evidence by imaging of a large ischemic core, as indicated by an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of less than 5 on computed tomography (CT) without the use of contrast material or a score of less than 4 on diffusion-weighted magnetic resonance imaging (MRI) (ASPECTS values range from 0 to 10, with higher values indicating less infarct burden). These cutoff values of the ischemic core have been selected in agreement with the treatment effect showed in the HERMES trial meta-analysis collaboration (Presented at the International Stroke Conference, Houston, 2017).
• Well-documented history of neuromuscular disorders, stroke or central nervous system tumors that could interfere in the SEPs assessment.

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

Location

Related Publications (5)

• Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

  PMID: 25882510 BACKGROUND

• Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.

  PMID: 27673305 BACKGROUND

• Lopez-Cancio E, Jovin TG, Cobo E, Cerda N, Jimenez M, Gomis M, Hernandez-Perez M, Caceres C, Cardona P, Lara B, Renu A, Llull L, Boned S, Muchada M, Davalos A. Endovascular treatment improves cognition after stroke: A secondary analysis of REVASCAT trial. Neurology. 2017 Jan 17;88(3):245-251. doi: 10.1212/WNL.0000000000003517. Epub 2016 Dec 9.

  PMID: 27940648 BACKGROUND

• Davalos A, Cobo E, Molina CA, Chamorro A, de Miquel MA, Roman LS, Serena J, Lopez-Cancio E, Ribo M, Millan M, Urra X, Cardona P, Tomasello A, Castano C, Blasco J, Aja L, Rubiera M, Gomis M, Renu A, Lara B, Marti-Fabregas J, Jankowitz B, Cerda N, Jovin TG; REVASCAT Trial Investigators. Safety and efficacy of thrombectomy in acute ischaemic stroke (REVASCAT): 1-year follow-up of a randomised open-label trial. Lancet Neurol. 2017 May;16(5):369-376. doi: 10.1016/S1474-4422(17)30047-9. Epub 2017 Mar 16.

  PMID: 28318984 BACKGROUND

• Alicia Martinez-Piñeiro , Giuseppe Lucente, María Hernandez-Perez, Jordi Cortés, Andrea Arbex, Natalia Pérez de la Ossa, Alba Ramos-Fransí, Miriam Almendrote, Mònica Millán, Meritxell Gomis, Laura Dorado, Carlos Castaño, Sebastián Remollo, Patricia Cuadras, Alicia Garrido, Nicolau Guanyabens, Joaquim Broto, Elena López-Cancio, Jaume Coll-Canti, Antoni Dávalos 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, originally publishedJune 14, 2023, https://doi.org/10.1161/SVIN.122.000735

  RESULT

MeSH Terms

Conditions

Stroke

Interventions

Evoked Potentials, Somatosensory

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antoni Dávalos Errando, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: September 23, 2019
• Study Start: January 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)