- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
5
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jun wei Hao, MD
- Telefonnummer: 01083198277
- E-post: haojunwei@vip.163.com
Studieorter
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-
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Beijing, Kina
- Xuanwu Hospital
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Kontakt:
- Junwei Hao, MD
- Telefonnummer: 01083198277
- E-post: haojunwei@vip.163.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Dichotomized mRS of 0-2 vs. 3-6
Tidsram: 90(±28)days
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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)
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90(±28)days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Ordinal mRS score
Tidsram: 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)
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90 (±28) days
|
|
Dichotomized mRS of 0-2 vs. 3-6
Tidsram: 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
|
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Score on the BI at 90 (±28) days and 180(±28) days
Tidsram: 90 (±28) days and 180(±28) days
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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.
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90 (±28) days and 180(±28) days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 juli 2026
Primärt slutförande (Beräknad)
15 december 2026
Avslutad studie (Beräknad)
28 juli 2029
Studieregistreringsdatum
Först inskickad
15 juli 2026
Först inskickad som uppfyllde QC-kriterierna
28 juli 2026
Första postat (Faktisk)
3 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- xw206-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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