Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity (CIPAN)
12 août 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
48
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Conversational speech
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neurofunctional activation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 janvier 2027
Achèvement primaire (Estimé)
1 janvier 2029
Achèvement de l'étude (Estimé)
1 juillet 2029
Dates d'inscription aux études
Première soumission
31 juillet 2026
Première soumission répondant aux critères de contrôle qualité
6 août 2026
Première publication (Réel)
12 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Manifestations neurocomportementales
- Troubles de la communication
- Troubles du langage
- Aphasie
- Troubles de la parole
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Accident vasculaire cérébral
- Aphasie, Broca
- 4-deethylatrazine
Autres numéros d'identification d'étude
- C-SEJ-127-UGR23
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .