Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG

Not yet recruiting

• Conditions: Anterior Large Vessel Occlusion Stroke

• Registration Number: NCT06564129
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Study Start: 2024-09-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1194

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;	24 hours	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

Secondary Outcome Measures

Name	Time	Method
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;	24 hours	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.
Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data	24 hours	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.
Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;	24 hours	Remove EEG data artifacts and report the percentage of EEG data available for analysis for each patient

Trial Locations

Locations (1)

Xuanwu Hospital, Beijing; 🇨🇳 Beijing, Beijing, China