Study on the Incremental Predictive Value of Early Resting-State EEG Phenotypes for Functional Prognosis and Risk Stratification in Acute Ischemic Stroke

NCT07741669 | Not Yet Recruiting

• 1 other identifier: xw206-001
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, observational cohort study that plans to consecutively enroll 400 patients with acute ischemic stroke from July 2026 to July 2029. The study will not interfere with acute-phase treatment decisions; information on reperfusion and non-reperfusion treatment will be recorded according to the actual clinical care pathway. After completion of necessary acute treatment, once vital signs are stable and clinical conditions permit, all participants will undergo one resting-state EEG recording as early as possible, within 7 days after symptom onset or the last-known-well time. For patients receiving reperfusion therapy, EEG will be acquired after completion of the reperfusion procedure, and intervals such as onset-to-reperfusion initiation and completion of reperfusion-to-EEG acquisition will be recorded. For patients not receiving reperfusion therapy, EEG will be acquired after the stroke diagnosis is established, routine treatment has been initiated, and the clinical condition is stable; onset-to-admission and onset-to-EEG acquisition intervals will be recorded. EEG features will be extracted and combined with clinical and imaging variables to construct prognostic models. The primary outcome is functional outcome at 3 months after onset, dichotomized as mRS 0-2 versus 3-6. The primary analysis will evaluate the incremental predictive value of EEG phenotypes for poor 3-month functional outcome beyond a conventional clinical-imaging model. Secondary analyses will include validation of 6-month outcomes, functional and cognitive scale outcomes, and differences in EEG phenotypes across treatment pathways.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Dichotomized mRS of 0-2 vs. 3-6

  Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  90(±28)days

Secondary Outcomes (3)

• Ordinal mRS score

  90 (±28) days

• Dichotomized mRS of 0-2 vs. 3-6

  180(±28) days

• Score on the BI at 90 (±28) days and 180(±28) days

  90 (±28) days and 180(±28) days

Eligibility Criteria

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

Study Population

The study population will consist of stroke patients treated at Xuanwu Hospital, Capital Medical University. Participants will be grouped according to their actual treatment pathway into a reperfusion therapy group and a non-reperfusion therapy group. The study team will record the type of reperfusion therapy, key treatment time points, and related information.

You may qualify if:

• Age \>=18 years, regardless of sex;
• Meets diagnostic criteria for acute ischemic stroke, supported by cranial CT/MRI and/or vascular imaging;
• Symptom onset time or last-known-well time is clear;
• Clinical assessment indicates that resting-state EEG can be completed without delaying acute treatment;
• Pre-stroke mRS \<=2, or basic independence in daily living before stroke;
• The patient, legal guardian, or impartial witness provides informed consent to participate in this study.
• The primary analysis population will be restricted to patients with mild-to-moderate to moderately severe acute ischemic stroke; an NIHSS score of 4-18 is recommended.

You may not qualify if:

• Primary diagnosis of hemorrhagic stroke, cerebral venous sinus thrombosis, brain tumor, encephalitis, severe traumatic brain injury, or other non-ischemic brain injury;
• Pre-existing marked neurological disability, pre-stroke mRS \>2, severe prior dementia, or severe psychiatric disorder that would make follow-up functional or cognitive outcomes difficult to interpret;
• Persistent deep sedation, coma, mechanical ventilation, severe metabolic disturbance, severe infection, or other conditions at the time of EEG acquisition that the investigator judges would markedly affect resting-state EEG background activity;
• Status epilepticus or recent frequent clinical seizures around the time of EEG acquisition that the investigator judges would substantially affect interpretation of resting-state EEG;
• Any other condition that the investigator judges unsuitable for participation in this study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jun wei Hao, MD

CONTACT

01083198277; haojunwei@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 3, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): July 28, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)