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Die klinische Studie NCT07208019 für Post-Stroke Cognitive Impairment (PSCI) ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Electroacupuncture Treatment for Post-stroke Cognitive Impairment 340 Nicht-invasiv Randomisiert Prävention
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07208019 ist eine interventionsstudie zur Untersuchung von Post-Stroke Cognitive Impairment (PSCI) und hat den Status offene rekrutierung. Die Studie startete am 5. Oktober 2025 und soll 340 Teilnehmer aufnehmen. Durchgeführt von Ruijie Ma ist der Abschluss für 30. März 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 17. Dezember 2025 aktualisiert.
Kurzbeschreibung
Stroke is a global public health issue, and it has become a leading cause of death and disability in China. With the rapid aging of the Chinese population, its incidence rate is continuously rising. According to the "China Stroke Prevention and Treatment Report (2023)", on average, one person experiences a new or recurrent stroke every 10 seconds in China, and one person dies from stroke every 28 seconds. Currently, ...Mehr anzeigen
Offizieller Titel
Study on the Key Technology of Acupoint Modulation-based Brain Electric Field Therapy for the Treatment of Post-stroke Cognitive Impairment
Erkrankungen
Post-Stroke Cognitive Impairment (PSCI)Weitere Studien-IDs
- 2025C02200
NCT-Nummer
Studienbeginn (tatsächlich)
2025-10-05
Zuletzt aktualisiert
2025-12-17
Studienende (vorauss.)
2027-03-30
Geplante Rekrutierung
340
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Stroke
PSCI
Post-stroke cognitive impairment
PSCI
Post-stroke cognitive impairment
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Schein-VergleichspräparatSham electroacupuncture group Treatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion | Akupunktur Sham electroacupuncture group: After local routine disinfection. Choose the same acupoints as the electroacupuncture group, but use a specially designed electroacupuncture instrument that cannot output current, with only indicator lights or parameter displays when in use. |
ExperimentellElectroacupuncture group Treatment with electro-acupuncture device on the basis of ordinary needling | Akupunktur Electroacupuncture group: After local routine disinfection.Select the main acupoints of bilateral frontoparietal line (MS2), Tianzhu (BL10), Fengchi (GB20), blood supply, parietal midline (MS5), and parietal midline (MS8). Connect the wires of the electroacupuncture instrument to the same side of the bilateral frontoparietal line(MS2) and Tianzhu acupoint (BL10), and perform head electroacupuncture treatment on both ...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Neuropsychological Test Battery(NTB) | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment | |
Montreal Cognitive Assessment | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment | |
Mini-Mental State Examination | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Modified Barthel Index | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment | |
Hamilton Depression Scale(HAMD) | \<7 indicates no, 7-17 indicates possible, 17-24 indicates certain,\>24 indicates severe depression. The lowest score is 0, and the highest score is 46. The higher the score, the more severe the patient's depression. | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
Electroencephalogram(EEG) | Evaluate the quantitative electroencephalogram parameters alpha wave, beta wave, delta wave, and theta wave absolute power, as well as the (delta+theta)/(alpha+beta) ratio (DTABR) and delta/alpha power ratio (DAR), and analyze the correlation between various parameters and cognitive function. | Pre-treatment, 8th week post-treatment |
Near-infrared spectroscopy | Pre-treatment, 8th week post-treatment | |
Modified Rankin Scale(mRS) | The scoring criteria are 0-5 points, with 0 being completely asymptomatic and 5 being severely disabled. | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
Pittsburgh sleep quality index(PSQI) | It consists of seven dimensions: subjective sleep quality, falling asleep time, sleep duration, sleep disturbances, use of hypnotic drugs, daytime functional disorders, and sleep efficiency. Each dimension scores 0-3 points, with a minimum score of 0 and a maximum score of 21 points. The higher the score, the more severe the sleep problem. The total score of the seven dimensions is the PSQI score. | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
Magnetic Resonance Imaging | Pre-treatment, 8th week post-treatment | |
Short Form 12 Health Survey(SF-12) | This scale covers eight aspects: physical function, physical role, pain, general health, mental health, social function, emotional role, and psychological health. The overall score range is 0-100 points, with higher scores indicating better health conditions. | Week 8 after treatment |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
35 Years
Zugelassene Geschlechter
Alle
- According to the Western diagnostic criteria for vascular cognitive impairment outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment (2024 Edition)" developed by the Vascular Cognitive Impairment Branch of the Chinese Stroke Society.
- Meets the traditional Chinese medicine diagnostic criteria for vascular cognitive impairment in the "Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Vascular Mild Cognitive Impairment (2024)";
- The Mini Mental State Examination (MMSE) score ranges from 12-24, while the Montreal Cognitive Assessment (MoCA) score is below 24; Having cognitive impairment but not reaching the level of severe dementia; The National Institutes of Health Stroke Scale (NIHSS) score is ≤ 8 points; The Early Dementia Screening Scale (Ascertain Dementia 8, AD-8) score is less than 2 points;
- Age between 35-80 years old;
- Have basic communication skills, with Mandarin as the main language (communication language is sufficient), and have at least one stable caregiver;
- Sign the informed consent form.
- Merge serious primary chronic diseases such as heart, liver, kidney, endocrine system, and hematopoietic system, as well as severe cardiovascular and cerebrovascular diseases;
- Skin diseases or scar constitution such as herpes and ulceration are easy to appear on the body surface, which is not suitable for acupuncture and moxibustion treatment;
- Not suitable for repetitive MRI examinations, such as claustrophobia, arterial aneurysm embolization, etc;
- Patients with cognitive impairment or other severe neurological or mental disorders prior to the onset of this illness, and unstable control;
- Patients identified by other clinical trial personnel as unsuitable for this study;
- Participated in clinical research on related diseases in the past 3 months;
Ruijie MaVerantwortliche Partei
Ruijie Ma, Prüfsponsor, Project sponsor, principal investigator, project leader, professor, The Third Affiliated hospital of Zhejiang Chinese Medical University
Zentrale Studienkontakte
Kontakt: Bowen Chen, +86 13967988987, [email protected]
Kontakt: Luyao Fu, +86 18457100195, [email protected]
5 Studienstandorte in 1 Ländern
Zhejiang
Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, 310006, China
Fengjia Ni, Kontakt, 19816878056, [email protected]
Offene Rekrutierung
Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, 310007, China
Liping Li, Kontakt, 13857161334, [email protected]
Noch nicht rekrutierend
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Lusha Tong, Kontakt, 15868171218, [email protected]
Noch nicht rekrutierend
The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China
Kun Yan, Kontakt, +86 28 8542 4855, [email protected]
Ruijie Ma, Kontakt, +86 18057102851, [email protected]
Offene Rekrutierung
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 314408, China
Xinyun Li, Kontakt, 18069783240, [email protected]
Offene Rekrutierung