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Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity (CIPAN)

12. august 2026 opdateret af: Antonio Bernal Benítez, Universidad de Granada

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

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
CIPAN = MIT + CIAT
Adfærdsmæssigt: CIPAN = 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.
Aktiv komparator: Control group 1
MIT + MIT
Adfærdsmæssigt: MIT + 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.
Aktiv komparator: Control group 2
CIAT + CIAT
Adfærdsmæssigt: CIAT + 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Conversational speech
Tidsramme: 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)
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
Repetition
Tidsramme: 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)
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)
Tidsramme: 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)
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)
Tidsramme: 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)
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
Tidsramme: 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)
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
Tidsramme: 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)
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neurofunctional activation
Tidsramme: 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)
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
Auditive comprehension
Tidsramme: 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)
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)
Depression
Tidsramme: 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) and Stroke Aphasia Depression Questionnaire (SADQ-10)
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
Tidsramme: 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)
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
Tidsramme: 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)
At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Granada

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. juli 2029

Datoer for studieregistrering

Først indsendt

31. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C-SEJ-127-UGR23

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