- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07854665
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents: A Randomized Controlled Clinical Trial
The objective of this trial is to evaluate the effect of transcutaneous auricular vagus nerve stimulation compared to sham stimulation in improving chronic tic disorder or Tourette's syndrome in children and adolescents.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants will be randomly assigned to receive transcutaneous auricular vagus nerve stimulation or sham stimulation. Both interventions will be administered 5 times per week for 8 weeks. Study outcomes will be evaluated at baseline and at weeks 4, 8, and 12.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Simeng Wang, PHD
- Número de teléfono: 8618811022134
- Correo electrónico: 18811022134@163.com
Copia de seguridad de contactos de estudio
- Nombre: Zhiyi Xiong, PHD
- Número de teléfono: 8618811022104
- Correo electrónico: zhiyixiong@foxmail.com
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310000
- The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU)
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Contacto:
- Simeng Wang, PHD
- Número de teléfono: 8618811022134
- Correo electrónico: 18811022134@163.com
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Contacto:
- Zhiyi Xiong, PHD
- Número de teléfono: 8618811022104
- Correo electrónico: zhiyixiong@foxmail.com
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Investigador principal:
- Simeng Wang, PHD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- Meets the DSM-5 diagnostic criteria for Tourette syndrome or chronic motor or vocal tic disorder;
- Age ≥6 and <18 years;
- YGTSS-TTS >15, or >10 for participants with motor tics or vocal tics only;
- If the participant is taking medication at enrollment, the medication regimen and dosage must have been stable for at least 4 weeks, with no planned changes in medication or dosage during the study;
- Has not received any non-pharmacological treatment for tics (e.g., acupuncture, transcranial magnetic stimulation, deep brain stimulation) within the preceding 8 weeks;
- Provides written informed consent.
Exclusion Criteria
- Mental or cognitive disability that would preclude participation in the study;
- Ear skin lesions, such as infection or eczema;
- An implanted cardiac pacemaker or other electronic medical device;
- Severe physical diseases, such as coronary heart disease, malignancy, or renal failure;
- Current participation in another clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Transcutaneous auricular vagus nerve stimulation
Participants will receive transcutaneous auricular vagus nerve stimulation five times per week for eight consecutive weeks. |
Participants in the transcutaneous auricular vagus nerve stimulation group will receive stimulation at auricular acupoints located within the distribution area of the vagus nerve. A Hwato SDZ-II B electroacupuncture apparatus will be employed, with the two connecting clips of the same output lead attached to the acupoints on the same side. Disperse-dense wave stimulation will be applied, with the intensity adjusted according to the patient's tolerance, and each session will last 30 minutes. |
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Comparador falso: Sham stimulation
Participants will receive sham stimulation five times per week for eight consecutive weeks. |
Participants in the sham group will receive electrical stimulation at auricular acupoints located outside the distribution area of the vagus nerve, with a current intensity of 0.1 mA. All other procedures will be identical to those of the treatment group. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Yale Global Tic Severity Scale Total Tic Score
Periodo de tiempo: Week 8 (post treatment).
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The Yale Global Tic Severity Scale (YGTSS) is a clinician-rated instrument designed to evaluate the severity of motor tics, phonic tics, and overall impairment over the preceding week. Motor and vocal tics are rated independently across five dimensions (number, frequency, intensity, complexity, and interference; range 0-5 each), and the dimension scores are summed to yield separate Motor and Vocal Tic scores (range 0-25 each) as well as a combined YGTSS Total Tic Score (range 0-50), with higher scores indicating greater tic severity. The YGTSS Impairment Rating captures tic-related distress and functional impact (range 0-50). The YGTSS Total Tic Score and the YGTSS Impairment Rating are summed to produce a YGTSS total score (range 0-100), with higher scores indicating greater overall severity. |
Week 8 (post treatment).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Yale Global Tic Severity Scale Total Score
Periodo de tiempo: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
|
The Yale Global Tic Severity Scale (YGTSS) is a clinician-rated instrument assessing motor tics, vocal tics, and impairment over the preceding week. Motor and vocal tics are each rated on five dimensions (number, frequency, intensity, complexity, and interference; 0-5 each), yielding Motor and Vocal Tic scores (0-25 each) and a YGTSS Total Tic Score (0-50). The YGTSS Impairment (0-50) is added to the YGTSS Total Tic Score to produce a YGTSS Total Score (0-100), with higher scores indicating greater severity. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Children's Yale-Brown Obsessive Compulsive Scale
Periodo de tiempo: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) will be used to assess the severity of obsessive-compulsive symptoms in children and adolescents. The total score of CY-BOCS ranges from 0 to 40, with higher scores indicate greater symptom severity. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Swanson, Nolan, and Pelham-IV-18
Periodo de tiempo: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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The Swanson, Nolan, and Pelham Rating Scale version IV (SNAP-IV-18) will be used to assess symptoms of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The total score of SNAP-IV-18 ranges from 0 to 54, with higher scores indicate more severe symptoms. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life
Periodo de tiempo: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life (C&A-GTS-QOL) questionnaire will be used to assess health-related quality of life in children and adolescents with Tourette syndrome. The total score of C&A-GTS-QOL is typically transformed to a 0-100 scale, with higher scores indicating greater impairment and poorer quality of life. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse Events
Periodo de tiempo: Week 0 (baseline) to week 12.
|
An adverse event is any unexpected symptom, sign, or health condition occurring after initiation of study treatment, which may or may not be related to the study intervention. Pre-existing health conditions or diseases will only be considered as adverse events if they worsen after enrollment. |
Week 0 (baseline) to week 12.
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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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Enfermedades Genéticas Congénitas
- Enfermedades neurodegenerativas
- Trastornos del neurodesarrollo
- Trastornos del movimiento
- Trastornos Heredodegenerativos, Sistema Nervioso
- Enfermedades de los ganglios basales
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Trastornos de tics
- Síndrome de Tourette
Otros números de identificación del estudio
- FirstZhejiangCMU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Deidentified participant data will be available from the study PI upon reasonable request after publication.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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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