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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidad de Granada
- Enrollment
- 48
- Primary Endpoint
- Conversational speech
Study Overview
Brief Summary
Sequentially applying Melodic Intonation Therapy (MIT) during the subacute phase, followed by Constraint-Induced Aphasia Therapy (CIAT) during the chronic phase
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Experimental group
CIPAN = MIT + CIAT
Intervention: CIPAN = MIT + CIAT (Behavioral)
Control group 1
MIT + MIT
Intervention: MIT + MIT (Behavioral)
Control group 2
CIAT + CIAT
Intervention: CIAT + CIAT (Behavioral)
Outcomes
Primary Outcomes
Conversational speech
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
- 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))
- 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))
- Depression(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(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(At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225))
Investigators
Antonio Bernal Benítez
Associate professor
Universidad de Granada