- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07598175
Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics
The goal of this clinical study is to find out whether different electronic acupuncture wave forms can effectively treat recovery-stage Bell's palsy in adults and evaluate their safety.
The main questions it aims to answer are:
- Can targeted electronic acupuncture wave forms improve facial nerve function in patients with Bell's palsy?
- What is the optimal electronic acupuncture waveform for different degrees of facial nerve injury?
- What adverse events may occur during electronic acupuncture treatment? Researchers will compare low-frequency continuous wave electronic acupuncture and intermittent wave electronic acupuncture to determine which waveform works better for recovery-stage Bell's palsy.
Participants will:
- Receive either low-frequency continuous wave electronic acupuncture or intermittent wave electronic acupuncture every other day for 4 weeks
- Undergo surface sEMG and ENoG examinations at baseline, Week 2, and Week 4
- Complete facial function assessments and safety evaluations at each clinic visit
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jing Sun
- Número de teléfono: 13429610268
- Correo electrónico: sunjing0268@163.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria for Bell's Palsy Subjects:
- Meet the above Bell's palsy diagnostic criteria;
- Age 18-65 years, either gender;
- Disease course in recovery phase (21 days ≤ course ≤ 6 months) and not recovered (FNGS 2.0 score >4);
- Voluntarily participate in this study and sign informed consent.
Inclusion Criteria for Healthy Subjects:
- Do not meet the above Bell's palsy diagnostic criteria;
- Age 18-65 years, either gender, matched to Bell's palsy subjects within 5 years for age and gender;
- Normal facial nerve function, FNGS 2.0 score = 4;
- Voluntarily participate in this study and sign informed consent.
Exclusion Criteria for Bell's Palsy Subjects:
- Facial trauma, skin lesions, or other diseases that may cause facial paralysis symptoms;
- Diagnosed with Ramsay Hunt syndrome (herpes zoster oticus);
- Bilateral facial paralysis;
- Previous history of facial paralysis;
- Facial synkinesis, contracture, or spasm already present;
- History of facial surgery;
- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
Exclusion Criteria for Healthy Subjects:
- Facial trauma, skin lesions, or other diseases that may affect facial muscle activity;
- Previous history of facial paralysis;
- History of facial surgery;
- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Non-severe injury + Low-frequency continuous wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimental: Non-severe injury + Interrupted wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimental: Severe injury + Low-frequency continuous wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimental: Severe injury + Interrupted wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
FNGS2.0
Periodo de tiempo: week4
|
FNGS 2.0 stands for Facial Nerve Grading System 2.0, with a total score range of 4 to 24; lower scores indicate better facial nerve function (4 = normal), while higher scores indicate more severe facial paralysis (24 = complete facial palsy).
|
week4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sunnybrook Facial Grading System,SBGS
Periodo de tiempo: week4
|
1.SBGS:Score range: 0-100, with higher scores indicating better facial nerve function.
|
week4
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GZY-KJS-ZJ-2026-056
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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