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NCT06149754: PROMISE20
BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy
trial testing BraiN20(R) monitoring of N20 somatosensory evoked potential in Acute Stroke in 65 participants. Status unknown.
28 February 2024
Quick facts
| Lead sponsor | Fundació Institut Germans Trias i Pujol |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 65 |
| Start date | 15 September 2023 |
| Primary completion | 28 February 2024 |
| Estimated completion | 31 May 2024 |
| Sites | 3 locations across Spain |
Drugs / interventions tested
- BraiN20(R) monitoring of N20 somatosensory evoked potential
Conditions studied
- Acute Stroke — all drugs for Acute Stroke →
- Mechanical Thrombectomy — all drugs for Mechanical Thrombectomy →
Sponsor
Fundació Institut Germans Trias i Pujol — full company profile →
Who can join
18 and older, any sex, with Acute Stroke or Mechanical Thrombectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06149754
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06149754 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundació Institut Germans Trias i Pujol
- Last refreshed: 29 November 2023
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