Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT07496762 per Sequele dell'ictus, Disturbi della deglutizione, Terapia con agopuntura, Elettro-agopuntura è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks 90 Randomizzato
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07496762 è uno studio interventistico per Sequele dell'ictus, Disturbi della deglutizione, Terapia con agopuntura, Elettro-agopuntura, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 21 aprile 2026, con l'obiettivo di raggiungere 90 partecipanti. Sotto la guida di Kaili Chen, dovrebbe concludersi entro il 21 dicembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-d...Mostra di più
Titolo ufficiale
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
Patologie
Sequele dell'ictusDisturbi della deglutizioneTerapia con agopunturaElettro-agopunturaAltri ID dello studio
- ZSLL-KY-2025-132-01
Numero NCT
Data di inizio (effettiva)
2026-04-21
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2028-12-21
Arruolamento (previsto)
90
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
Stroke Sequelae
Deglutition Disorders
Acupuncture Therapy
Electroacupuncture
Deglutition Disorders
Acupuncture Therapy
Electroacupuncture
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleLow Frequency EA Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 2Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. | Low Frequency EA Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 2 Hz (Low Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. |
SperimentaleMedium Frequency EA Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 50Hz.The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. | Medium Frequency EA Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 50 Hz (Medium Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. |
SperimentaleHigh Frequency EA Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 100Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. | High Frequency EA Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 100 Hz (High Frequency).The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in Water Swallow Test (WST) Score | The WST is a screening tool for dysphagia. It assesses the ability to swallow water and the presence of coughing or choking. Scores range from 1 to 5, with higher scores indicating more severe dysphagia. Improvement is defined as a decrease in the WST score. | Baseline and Week 6 (End of treatment) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in Penetration-Aspiration Scale (PAS) Score via VFSS | The PAS is an 8-point scale used to describe the severity of penetration and aspiration events during a Videofluoroscopic Swallowing Study (VFSS). Lower scores indicate safer swallowing function. | Baseline and Week 6 (End of treatment) |
Hyolaryngeal excursion measured by Ultrasound | B-mode ultrasound will be used to measure the anterior and superior displacement distance of the hyoid bone and larynx during swallowing. Greater displacement indicates better function of the suprahyoid muscles. | Baseline and Week 6 (End of treatment) |
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways | Diffusion Tensor Imaging (DTI) will be used to measure the Fractional Anisotropy (FA) values of white matter fiber tracts connecting the bilateral precentral gyrus, insula, supramarginal gyrus, frontal lobe, and the nucleus of the solitary tract. Higher FA values indicate better structural integrity of the neural network. | Baseline and Week 6 (End of treatment) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Diagnosis: Patients diagnosed with cerebral infarction confirmed by CT or MRI.
- Dysphagia Screening: Presence of varying degrees of dysphagia as screened by the Water Swallow Test (WST).
- Clinical Status: Conscious and stable vital signs, with the ability to cooperate with the treatment.
- Age: Aged between 18 and 80 years.
- Consent: Signed informed consent form obtained from the patient or their legal representative.
- Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cerebral infarction.
- MRI Contraindications: Patients with metal implants or pacemakers in the body (contraindications for MRI).
- Bleeding Risk: Patients with bleeding tendencies or coagulation disorders.
- Blood Pressure: Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg).
- Organ Failure: Patients with severe failure of vital organs (e.g., heart, liver, or kidney failure).
- Disease Severity: Patients with critical or life-threatening stroke conditions.
- Cooperation: Patients unable to cooperate with the treatment due to severe cognitive impairment, aphasia, or other reasons.
Kaili ChenParte responsabile dello studio
Kaili Chen, Promotore-investigatore, resident physician, The Third Affiliated hospital of Zhejiang Chinese Medical University
Contatti principali dello studio
Contatto: kaili chen, +8619858165101, [email protected]
1 Centri dello studio in 1 paesi
Zhejiang
the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310000, China
kaili chen, Contatto, +8619858165101, [email protected]