Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity (CIPAN)
12 de agosto de 2026 actualizado por: Antonio Bernal Benítez, Universidad de Granada
Combining Melodic Intonation Therapy and Constraint-Induced Aphasia Therapy for the Treatment of Non-fluent Aphasia: A Neuroplasticity-based Sequential Protocol for a Randomized Controlled Trial
Sequentially applying Melodic Intonation Therapy (MIT) during the subacute phase, followed by Constraint-Induced Aphasia Therapy (CIAT) during the chronic phase
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
48
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Have suffered a single LH stroke, with the RH remaining entirely intact;
- Have a diagnosis of non-fluent aphasia characterized by non-fluent speech-with or without agrammatism, paraphasias, or stereotypies-anomia, and relatively preserved auditory comprehension;
- Be within 9 weeks post-stroke at the time of enrollment;
- Have no hearing, neurological, or psychiatric impairments;
- Not be taking any medication that could affect language processing
Exclusion Criteria:
-
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: Experimental group
CIPAN = MIT + CIAT
|
The First Therapeutic Period (1st TP) takes place during the subacute phase, from 10 to 15 weeks since the patient's stroke onset.
The Second Therapeutic Period (2nd TP) occurs during the chronic phase, from 27 to 32 weeks since the patient's stroke onset.
MIT sessions (1st TP) will last one hours each and will be administered daily (5 days per week) over six weeks, amounting to a total of 30 hours of therapy.
CIAT sessions (2nd TP) will be three-hour long and delivered on a daily basis (also 5 days per week) for two weeks, resulting in a total of 30 hours of therapy.
|
|
Comparador activo: Control group 1
MIT + MIT
|
The First Therapeutic Period (1st TP) takes place during the subacute phase, from 10 to 15 weeks since the patient's stroke onset.
The Second Therapeutic Period (2nd TP) occurs during the chronic phase, from 27 to 32 weeks since the patient's stroke onset.
MIT sessions (1st TP) will last one hours each and will be administered daily (5 days per week) over six weeks, amounting to a total of 30 hours of therapy.
MIT sessions (2nd TP) will last one hours each and will be administered daily (5 days per week) over six weeks, amounting to a total of 30 hours of therapy.
|
|
Comparador activo: Control group 2
CIAT + CIAT
|
The First Therapeutic Period (1st TP) takes place during the subacute phase, from 10 to 15 weeks since the patient's stroke onset.
The Second Therapeutic Period (2nd TP) occurs during the chronic phase, from 27 to 32 weeks since the patient's stroke onset.
CIAT sessions (1st TP) will be three-hour long and delivered on a daily basis (also 5 days per week) for two weeks, resulting in a total of 30 hours of therapy.
CIAT sessions (2nd TP) will be three-hour long and delivered on a daily basis (also 5 days per week) for two weeks, resulting in a total of 30 hours of therapy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Conversational speech
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From The Cookie Theft picture description of the Boston Diagnostic Aphasia Examination (BDAE)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Repetition
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Word and sentence repetition test of the Boston Diagnostic Aphasia Examination (BDAE)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Naming (auditory confrontation)
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Responsive naming test of the Boston Diagnostic Aphasia Examination (BDAE)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Naming (visual confrontation)
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Boston Naming Test of the Boston Diagnostic Aphasia Examination (BDAE)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Verbal fluency
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Verbal Fluency Test (VFT)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Functional communication
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Communicative Activity Log (CAL)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neurofunctional activation
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
By Resting-State Functional MRI (rs-fMRI)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Auditive comprehension
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Commands test of the Boston Diagnostic Aphasia Examination (BDAE)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Depression
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
From the Signs of Depression Scale (SODS) and Stroke Aphasia Depression Questionnaire (SADQ-10)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
Lesion volume and extent
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
By MRI Voxel-based Lesion-Symptom Mapping (VLSM)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
|
White matter integrity
Periodo de tiempo: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
By MRI Diffusion Weighted Imaging (DWI)
|
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de enero de 2029
Finalización del estudio (Estimado)
1 de julio de 2029
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2026
Publicado por primera vez (Actual)
12 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Manifestaciones neuroconductuales
- Desordenes comunicacionales
- Trastornos del lenguaje
- Afasia
- Trastornos del habla
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Carrera
- Afasia, Broca
- 4-deethylatrazine
Otros números de identificación del estudio
- C-SEJ-127-UGR23
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .