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Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG

Characteristics and Prehospital Triage of Anterior Large Vessel Occlusion Stroke Based on EEG

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06564129
Enrollment
1194
Registered
2024-08-21
Start date
2024-09-01
Completion date
2025-12-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Large Vessel Occlusion Stroke

Keywords

anterior large vessel occlusion stroke, electroencephalography, prehospital triage

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.

Interventions

DEVICEelectroencephalography

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).

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;24 hoursAccuracy 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

MeasureTime frameDescription
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 hoursROC curves were plotted for each EEG data feature predicting LVO-a, 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 hoursRemove EEG data artifacts and report the percentage of EEG data available for analysis for each patient
Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data24 hoursROC curves for predicted LVO-a based on this algorithm were plotted and sensitivity, specificity, PPV and NPV were calculated at the optimal cutoff value.

Countries

China

Contacts

Primary Contactjunwei Hao, MD
haojunwei@vip.163.com01083198277
Backup ContactGaoting Ma, MD
demo_doctor@163.com18301579891

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026