Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG

NCT ID: NCT06564129

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Anterior Large Vessel Occlusion Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DEVICE

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Junwei Hao, MD

Characteristics and prehospital triage of anterior large vessel occlusion stroke based on EEG

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

junwei Hao, MD

Role: CONTACT

haojunwei@vip.163.com

01083198277

Gaoting Ma, MD

Role: CONTACT

demo_doctor@163.com

18301579891

Other Identifiers

XMEC-2024-01

Identifier Type: -

Identifier Source: org_study_id