- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07741669
Study on the Incremental Predictive Value of Early Resting-State EEG Phenotypes for Functional Prognosis and Risk Stratification in Acute Ischemic Stroke
28. juli 2026 opdateret af: Xuanwu Hospital, Beijing
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
5
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jun wei Hao, MD
- Telefonnummer: 01083198277
- E-mail: haojunwei@vip.163.com
Studiesteder
-
-
-
Beijing, Kina
- Xuanwu Hospital
-
Kontakt:
- Junwei Hao, MD
- Telefonnummer: 01083198277
- E-mail: haojunwei@vip.163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dichotomized mRS of 0-2 vs. 3-6
Tidsramme: 90(±28)days
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ordinal mRS score
Tidsramme: 90 (±28) days
|
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
Tidsramme: 180(±28) days
|
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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juli 2026
Primær færdiggørelse (Anslået)
15. december 2026
Studieafslutning (Anslået)
28. juli 2029
Datoer for studieregistrering
Først indsendt
15. juli 2026
Først indsendt, der opfyldte QC-kriterier
28. juli 2026
Først opslået (Faktiske)
3. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- xw206-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .