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Universidad VanderbiltBotox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis Fase IV 50 Aleatorizado Diseño cruzado
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07295288 está diseñado para estudiar el tratamiento de Sincinesia. Este es un estudio intervencionista de Fase IV. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de febrero de 2026 hasta completar 50 participantes. Dirigido por la Universidad Vanderbilt, se espera que finalice el 30 de junio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 29 de diciembre de 2025.
Resumen
Facial synkinesis is a condition that occurs following facial nerve (CN7) injury, typically secondary to Bell's palsy, trauma, surgery (e.g., acoustic neuroma resection), or malignancy. Synkinesis is due to aberrant regeneration of the facial nerve, where axons regrow improperly and result in misdirected innervation of facial muscles. This results in involuntary, uncoordinated muscle movements, where activation of on...Mostrar más
Descripción detallada
Facial synkinesis is a debilitating condition that occurs following injury to the facial nerve (CN7). It results from misdirected nerve regrowth, leading to involuntary, often conflicting muscle movements (e.g., eye closure during smiling or neck muscle tightening). This causes functional impairments (e.g., cheek biting, eating difficulties, reduced visibility), cosmetic concerns, and increased rates of anxiety and d...Mostrar más
Título oficial
Investigating the Efficacy of Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis Management
Condiciones médicas
SincinesiaOtros ID del estudio
- 251490
Número del NCT
Inicio del estudio (real)
2026-02-01
Última actualización
2025-12-29
Fecha de finalización (estimada)
2026-06-30
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Aún no recluta
Palabras clave
botulinum toxin
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
OtrosEven MRN Patients with MRNs ending in an even number will undergo their standard BT injections (CN7 muscle groups only) + non-CN7 muscle groups at their first treatment session, followed by standard BT injections alone at their second treatment session. | Botulinum Toxin Type A Injection [Botox] Patients will receive standard of care synkinesis treatment. Depending on the treatment arm, they will receive additional botox injections to temporalis and masseter muscle groups which will only be injected on the ipsilateral side to the facial nerve injury. Decision to include the temporalis and/or masseter muscles will be based on each patients response to screening questions regarding jaw pain/tightness or headac...Mostrar más |
OtrosOdd MRN Patients with MRNs that end in an odd number will undergo the reverse injection process (standard BT injections alone at first treatment session, followed by standard BT injections + non-CN7 muscle groups at their second treatment session). | Botulinum Toxin Type A Injection [Botox] Patients will receive standard of care synkinesis treatment. Depending on the treatment arm, they will receive additional botox injections to temporalis and masseter muscle groups which will only be injected on the ipsilateral side to the facial nerve injury. Decision to include the temporalis and/or masseter muscles will be based on each patients response to screening questions regarding jaw pain/tightness or headac...Mostrar más |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Synkinesis Assessment Questionnaire (SAQ) | This 9-item questionnaire assesses functional status (hyperactive and/or inappropriately active facial muscles) related to facial synkinesis and is already given at each clinic visit as a routine part of clinical practice. The survey is well validated for evaluating synkinesis symptoms in patients with facial nerve injury.
SAQ scale: 1 = seldom or not at all, 2 = occasionally, or very mildly, 3 = sometimes, or mildly, 4 = most of the time, or moderately, 5 = all the time, or severely | Pre-treatment and repeated 5 weeks post-treatment |
Headache Impact Test (HIT-6) | This 6-item questionnaire seeks to understand the severity of headaches and impact on every-day quality of life. The survey is widely validated for assessing headache symptom and burden. We plan to add in 3 additional questions to this survey including 1) how often do you experience headaches (1 = never or rarely, 2 = 1-2 days a week, 3 = 3-4 days a week, 4 = nearly every day), 2) on a scale of 1-10 (10 = most severe) how severe are your headaches, and 3) I feel as if my Botox injections improved my headaches (Y/N).
HIT-6 Scale: 1 = Never 2 = Rarely 3 = Sometimes 4 = Very often 5 = Always | Pre-treatment and repeated 5 weeks post-treatment |
Temporomandibular Disorder Questionnare (TMD-7) | This 7-item questionnaire assesses symptoms related to temporomandibular mandibular joint (TMJ) disorder. It asks about jaw pain, tightness, clicking and difficulty eating, among other things. We plan to add in 3 additional questions to this survey including 1) how often do you experience jaw pain/tightness (1 = never or rarely, 2 = 1-2 days a week, 3 = 3-4 days a week, 4 = nearly every day), 2) on a scale of 1-10 (10 = most severe) how severe is your jaw pain/tightness, and 3) I feel as if my Botox injections improved my jaw pain/tightness (Y/N).
TMD-7 Scale: 1 = Rarely or Never 2 = A few times a month 3 = Once or Twice a Week 4 = Nearly Every Day | Pre-treatment and repeated 5 weeks post-treatment |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- Age > 18 years.
- Current diagnosis of facial synkinesis due to facial nerve paralysis/paresis.
- Scheduled to undergo BT injection for management of facial synkinesis.
- Have undergone > 3 prior BT injection sessions at VUMC for facial synkinesis.
- Able to read and understand English.
- Symptoms of neck tightness, jaw tightness, or headaches.
- Cognitive impairment that would preclude the ability to provide informed consent
- Unable to read text on a written survey or computer screen
Universidad VanderbiltParte responsable del estudio
Priyesh Patel, Investigador principal, Assistant Professor, Vanderbilt University Medical Center
Contactos centrales del estudio
Contacto: Christine Little, MD, 6504555258, [email protected]
Contacto: Amy Wang, 2818859243, [email protected]
Sitio no especificado.