Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidad de Granada

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control group 1Active comparator 1 intervention
Group C: Control group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Conversational speech

From The Cookie Theft picture description of the Boston Diagnostic Aphasia Examination (BDAE)

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)
2

Repetition

From the Word and sentence repetition test of the Boston Diagnostic Aphasia Examination (BDAE)

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)
3

Naming (auditory confrontation)

From the Responsive naming test of the Boston Diagnostic Aphasia Examination (BDAE)

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)
4

Naming (visual confrontation)

From the Boston Naming Test of the Boston Diagnostic Aphasia Examination (BDAE)

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)

Secondary outcomes

1

Auditive comprehension

From the Commands test of the Boston Diagnostic Aphasia Examination (BDAE)

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)
2

Depression

From the Signs of Depression Scale (SODS) and Stroke Aphasia Depression Questionnaire (SADQ-10)

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)
3

Lesion volume and extent

By MRI Voxel-based Lesion-Symptom Mapping (VLSM)

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)
4

White matter integrity

By MRI Diffusion Weighted Imaging (DWI)

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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