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NCT Number: NCT07759375

Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity

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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Key information

Conditions

Non-fluent Aphasia Aphasia Aphasia, Broca Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. 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) (Goodglass et al., 2005)

  2. 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) (Goodglass et al., 2005)

  3. 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) (Goodglass et al., 2005)

  4. 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) (Goodglass et al., 2005)

  5. 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) (Portellano-Pérez & Martínez-Arias, 2020)

  6. 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) (Pulvermüller & Berthier, 2008)

Secondary outcomes

  1. Auditive comprehension

    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 Commands test of the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass et al., 2005)

  2. Depression

    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 Signs of Depression Scale (SODS) (Hammond et al., 2000; Rodríguez-Campello et al., 2022) and Stroke Aphasia Depression Questionnaire (SADQ-10) (Sutcliffe & Lincoln, 1998)

  3. Lesion volume and extent

    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)

    By MRI Voxel-based Lesion-Symptom Mapping (VLSM) (Bates et al., 2003)

  4. White matter integrity

    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)

    By MRI Diffusion Weighted Imaging (DWI) (Basser et al., 1994; Zhang et al., 2012)

  5. Neurofunctional activation

    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)

    By Resting-State Functional MRI (rs-fMRI)

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Acronym: CIPAN

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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