Status:
UNKNOWN
BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Collaborating Sponsors:
European Innovation Council
Anagram-ESIC
Conditions:
Acute Stroke
Mechanical Thrombectomy
Eligibility:
All Genders
18+ years
Brief Summary
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 ca...
Detailed Description
EVT is the gold standard treatment in patients with AIS and LVO (1). However, currently, the probability of severe functional dependence or death at 3 months remains between 14-31% according to the re...
Eligibility Criteria
Inclusion
- Acute ischemic stroke with large anterior vessel occlusion undergoing treatment with EVT according to local protocols.
- Age ≥18.
- No significant pre-stroke functional dependence (mRS ≤ 2).
- Patient treatable within 24 hours of symptom onset. Symptoms onset is defined as the time the patient was last seen well, and treatment point as the time of arterial puncture.
- Baseline NIHSS score obtained prior to procedure must be equal or higher than 6 points.
- Occlusion (mTICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA M1 segment or M2 suitable for EVT, as evidenced by CTA or MRA with or without concomitant cervical carotid occlusion or stenosis.
- Any infarct core, without volume restrictions, measured by ASPECT score or by PCT/DWI-MRI prior to EVT.
- Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the mechanical thrombectomy.
Exclusion
- Clinical criteria
- Patients with a well-documented history of neuromuscular diseases and other neurodegenerative disorders, prior stroke (TIA not excluded) or nervous system tumors that could interfere with SEP assessment.
- Serious, advanced, or terminal illness with anticipated life expectancy of less than three months.
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
- Known pregnant women. In case of women of childbearing potential (WOCBP) with no highly effective methods for birth control, a pregnancy test should be performed.
- Neuroimaging criteria
- CT or MR evidence of hemorrhage (the presence of microbleeds is allowed).
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- 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 lesion in the area where electrical stimulation will 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).
Key Trial Info
Start Date :
September 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06149754
Start Date
September 15 2023
End Date
May 31 2024
Last Update
November 29 2023
Active Locations (3)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain, 08916
2
Hospital Universitario Vall d'Hebrón
Barcelona, Spain
3
Hospital Universitario Doctor Josep Trueta
Girona, Spain