NCT07759375

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Jan 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

July 31, 2026

Last Update Submit

August 6, 2026

Conditions

Non-fluent Aphasia

Keywords

Non-fluent aphasiaNeuroplasticityMelodic Intonation TherapyConstraint-Induced Aphasia TherapySubacute phaseChronic phaseStroke

Outcome Measures

Primary Outcomes (6)

  • Conversational speech

    From The Cookie Theft picture description of the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass et al., 2005)

    At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

  • Repetition

    From the Word and sentence repetition test of the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass et al., 2005)

    At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

  • Naming (auditory confrontation)

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

    At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

  • Naming (visual confrontation)

    From the Boston Naming Test of the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass et al., 2005)

    At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

  • Verbal fluency

    From the Verbal Fluency Test (VFT) (Portellano-Pérez \& Martínez-Arias, 2020)

    At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

  • Functional communication

    From the Communicative Activity Log (CAL) (Pulvermüller \& Berthier, 2008)

    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 (5)

  • 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)

  • 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)

Study Arms (3)

Experimental group

EXPERIMENTAL

CIPAN = MIT + CIAT

Behavioral: CIPAN = MIT + CIAT

Control group 1

ACTIVE COMPARATOR

MIT + MIT

Behavioral: MIT + MIT

Control group 2

ACTIVE COMPARATOR

CIAT + CIAT

Behavioral: CIAT + CIAT

Interventions

CIPAN = MIT + CIATBEHAVIORAL

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.

Experimental group
MIT + MITBEHAVIORAL

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.

Control group 1
CIAT + CIATBEHAVIORAL

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.

Control group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aphasia, BrocaStroke

Interventions

4-deethylatrazine

Condition Hierarchy (Ancestors)

AphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 12, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

August 12, 2026

Record last verified: 2026-08