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Not yet recruitingNCT07759375CIPANUpdated Aug 14, 2026

Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity

An interventional study of CIPAN = MIT + CIAT and MIT + MIT in Non-fluent Aphasia, sponsored by Universidad de Granada. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Sex
All
01

Study summary

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

02

Conditions studied

  • Non-fluent Aphasia

Keywords

  • Non-fluent aphasia
  • Neuroplasticity
  • Melodic Intonation Therapy
  • Constraint-Induced Aphasia Therapy
  • Subacute phase
  • Chronic phase
  • Stroke
03

In context

Aphasia, Broca

35 studies on the registry are indexed under Aphasia, Broca; 11 are open to participants now.

This study's planned enrollment of 48 is above the median of 36 across 33 interventional studies indexed under Aphasia, Broca.

Browse Aphasia, Broca studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Experimental group

    CIPAN = MIT + CIAT

    Behavioral: CIPAN = MIT + CIAT

  • Active comparator
    Control group 1

    MIT + MIT

    Behavioral: MIT + MIT

  • Active comparator
    Control group 2

    CIAT + CIAT

    Behavioral: CIAT + CIAT

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.

06

What researchers measure

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)

  5. Verbal fluency

    From the Verbal Fluency Test (VFT)

    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)

  6. Functional communication

    From the Communicative Activity Log (CAL)

    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)

  5. Neurofunctional activation

    By Resting-State Functional MRI (rs-fMRI)

    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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07759375
Responsible party
Antonio Bernal Benítez (Associate professor, Universidad de Granada) — Principal investigator
First posted
Aug 12, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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