Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG

Xuanwu Hospital, Beijing1,194 enrolled

Overview

This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke.

This is a multicenter, prospective, observational study,which will screen a total of 1194 patients in the participating centers during the period of June 1, 2024-December 31, 2025, and record single scalp EEG signals with eyes open at rest in the lying position of the patients using a non-invasive EEG acquisition device, and collect clinical data.

Study Type

OBSERVATIONAL

Enrollment

1,194

Conditions

Anterior Large Vessel Occlusion Stroke

Interventions

electroencephalographyDEVICE

Fifty-nine EEG electrodes conforming to international standard points were placed using a saline electrode EEG cap (Gelfree, Prysmian, China), and an accompanying portable multimodal EEG acquisition system (Neurohub, Prysmian, China) was used. EEG data were collected using collect software (Brycon, China).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Phase I.1.Acute ischemic stroke caused by occlusion of the anterior circulation (intracranial origin of the internal carotid artery or proximal middle cerebral artery (M1/M2)) confirmed by CTA, MRA or DSA (diagnosis in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023")；2. Patient age ≥18 years；3: Last normal time to EEG acquisition time ≤ 72 hours；4: Signed informed consent. Phase II-III 1. Diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient 2. Patient age ≥18 years 3. Last normal time to EEG acquisition time ≤ 24 hours 4. Signed informed consent Exclusion Criteria: 1. Wounds in the area of electrode cap placement or active infection in the scalp; 2. Patients who do not cooperate with the EEG examination.

Locations (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;

Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of large vessel occlusion Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of anterior large vessel occlusion stroke

Time frame: 24 hours

Secondary Outcomes

Other EEG features including relative δ, θ, α power, δ/α ratio, δ+θ/α+β ratio, pdBSI, and WPLI diagnostic accuracy for LVO-a;

ROC curves were plotted for each EEG data feature predicting LVO-a, and sensitivity, specificity, PPV, and NPV were calculated at the optimal cutoff value.

Time frame: 24 hours

Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;

Remove EEG data artifacts and report the percentage of EEG data available for analysis for each patient

Time frame: 24 hours

Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data

ROC curves for predicted LVO-a based on this algorithm were plotted and sensitivity, specificity, PPV and NPV were calculated at the optimal cutoff value.

Time frame: 24 hours

Central Contacts

junwei Hao, MD

CONTACT

01083198277 haojunwei@vip.163.com

Gaoting Ma, MD

CONTACT

18301579891 demo_doctor@163.com

Data from ClinicalTrials.gov

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