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
| Registry | NCT07759375, acronym CIPAN |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 48 (Estimated) |
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| Sponsor | Universidad de Granada (Other) |
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| Conditions | Non-fluent Aphasia |
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| Interventions | CIPAN = MIT + CIAT, MIT + MIT, CIAT + CIAT (Behavioral) |
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| Dates | start 2027-01-01 (estimated), primary completion 2029-01-01 (estimated), completion 2029-07-01 (estimated), first posted 2026-08-12, last updated 2026-08-14 |
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Related Papers Related Patents Related Grants Related Experts
All trials for Non-fluent Aphasia All trials of CIPAN = MIT + CIAT All trials of MIT + MIT
-Summary
Sequentially applying Melodic Intonation Therapy (MIT) during the subacute phase, followed by Constraint-Induced Aphasia Therapy (CIAT) during the chronic phase
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Experimental group | Experimental | Behavioral: CIPAN = MIT + CIAT | CIPAN = MIT + CIAT |
| Control group 1 | Active comparator | Behavioral: MIT + MIT | MIT + MIT |
| Control group 2 | Active comparator | Behavioral: CIAT + CIAT | CIAT + CIAT |
- CIPAN = MIT + CIAT (Behavioral): 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.
- MIT + MIT (Behavioral): 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.
- CIAT + CIAT (Behavioral): 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.
+Outcome measures
Primary outcomes
- Conversational speech [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)
- Repetition [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)
- Naming (auditory confrontation) [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)
- Naming (visual confrontation) [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)
- Verbal fluency [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)
- Functional communication [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)
Secondary outcomes
- Auditive comprehension [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)
- Depression [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)
- Lesion volume and extent [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)
- White matter integrity [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)
- Neurofunctional activation [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)
+Eligibility
Sex: All
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:
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