Skip to content

Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07759375
Acronym
CIPAN
Enrollment
48
Registered
2026-08-12
Start date
2027-01-01
Completion date
2029-07-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-fluent Aphasia

Keywords

Non-fluent aphasia, Neuroplasticity, Melodic Intonation Therapy, Constraint-Induced Aphasia Therapy, Subacute phase, Chronic phase, Stroke

Brief summary

Sequentially applying Melodic Intonation Therapy (MIT) during the subacute phase, followed by Constraint-Induced Aphasia Therapy (CIAT) during the chronic phase

Interventions

BEHAVIORALCIPAN = 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.

BEHAVIORALMIT + 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.

BEHAVIORALCIAT + 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.

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

\-

Design outcomes

Primary

MeasureTime frameDescription
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 fluencyAt 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 communicationAt 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)
Conversational speechAt 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)
RepetitionAt 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)

Secondary

MeasureTime frameDescription
White matter integrityAt 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 activationAt 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)
Auditive comprehensionAt 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)
DepressionAt 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 extentAt 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026