Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: electroencephalography.
- Who it may be relevant to
- Registry conditions: Anterior Large Vessel Occlusion Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characteristics and Prehospital Triage of Anterior Large Vessel Occlusion Stroke Based on EEG
Overview
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
- Device electroencephalography
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).
Primary outcome measures
- Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio; [Time frame: 24 hours]
Secondary outcome measures (3)
- 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; [Time frame: 24 hours]
- Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics; [Time frame: 24 hours]
- Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data [Time frame: 24 hours]
Eligibility criteria
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
- Diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient
- Patient age ≥18 years
- Last normal time to EEG acquisition time ≤ 24 hours
- Signed informed consent
Exclusion criteria
- Wounds in the area of electrode cap placement or active infection in the scalp;
- Patients who do not cooperate with the EEG examination.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xuanwu Hospital, Beijing — Beijing
Identifiers
NCT: NCT06564129 · XMEC-2024-01