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NCT Number: NCT06564129

Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG

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

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Key information

Conditions

Anterior Large Vessel Occlusion Stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalography

Device

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 outcomes

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

    Time frame: 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 outcomes

  1. 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

    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.

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

    Time frame: 24 hours

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

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gaoting Ma, MD

CONTACT

[email protected]

18301579891

junwei Hao, MD

CONTACT

[email protected]

01083198277

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.