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

NCT04099615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 228

Last updated 2023-11-08

No results posted yet for this study

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

Interventions

PROCEDURE

Somatosensory Evoked Potentials

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.

Sponsors & Collaborators

  • Fundació La Marató de TV3

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Antoni Dávalos Errando, PhD · Fundació Institut d'Investigació en Ciències de la Salut Germans Trias iPujol

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04099615 on ClinicalTrials.gov