Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG

NCT06564129 | Not Yet Recruiting

• 1 other identifier: XMEC-2024-01
• Study Type: observational
• Target: 1,194
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anterior Large Vessel Occlusion Stroke

Keywords

anterior large vessel occlusion stroke; electroencephalography; prehospital triage

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (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;

  24 hours

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

  24 hours

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

  24 hours

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with suspected stroke or known stroke were included in the study

You may qualify if:

• 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

You may not qualify if:

• Wounds in the area of electrode cap placement or active infection in the scalp;
• Patients who do not cooperate with the EEG examination.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

junwei Hao, MD

CONTACT

01083198277; haojunwei@vip.163.com

Gaoting Ma, MD

CONTACT

18301579891; demo_doctor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Characteristics and prehospital triage of anterior large vessel occlusion stroke based on EEG

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)