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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke

• Study Type: Observational
• Enrollment (Estimated): 5

Contacts and Locations

• Study Contact: Name: Jun wei Hao, MD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital
    • Contact: Junwei Hao, MD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ordinal mRS score	Ordinal mRS score at 90 (±28) 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
Dichotomized mRS of 0-2 vs. 3-6	Dichotomized mRS of 0-2 vs. 3-6 at 180(±28) 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)	180(±28) days
Score on the BI at 90 (±28) days and 180(±28) days	Barthel Index，BI: The total score is 100 points. The higher the score, the better the independence and the lower the dependence.If the total score is ≤ 40 points, it indicates severe dependence, and full - time care by others is required.If the total score is between 41 - 60 points, it indicates moderate dependence, and most of the care needs to be provided by others.If the total score is between 61 - 99 points, it indicates mild dependence, and only a small part of care needs to be provided by others.If the total score is 100 points, it indicates no dependence, and no care from others is required.	90 (±28) days and 180(±28) days

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): July 28, 2029

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: xw206-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No