NCT07198048

Brief Summary

The goal of this clinical trial is to learn if a music-based intervention can acutely improve three types of attention (alerting, orientating, executive control) in people with aphasia following a stroke. The main questions it aims to answer are:

  1. 1.Is a music based intervention effective at improving attention with someone who has aphasia?
  2. 2.Does music-induced changes in attention improve language abilities and quality of life with someone who has aphasia? Researchers will compare a group that listening to music, to listing to an audiobook group, to a group that serves as a control to see if there are changes in attention over time.
  3. 3.Listen to music or an audiobook for 30 minutes a day for 8 weeks
  4. 4.Complete a daily journal about each day's listening experience
  5. 5.Complete three testing sessions where attention, language, and quality of life are assessed.

Trial Health

65
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Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Oct 2025

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

Study Progress22%
Oct 2025Jul 2028

First Submitted

Initial submission to the registry

September 25, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

September 25, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

strokeaphasiaattentionlanguagemusicmusic intervention

Outcome Measures

Primary Outcomes (3)

  • Change in attention from T1 to T2 and T3

    Attention will be measured in each group through the Visual Attention Network Task. Changes in attention will be calculated between timepoint 1 (T1), timepoint 2 (T2) and timepoint 3 (T3).

    From T1 to T2 (11 weeks for the experimental and active control arms, 9 weeks for the no-contact arm) and to T3 (8 weeks after T2)

  • Change in language from T1 to T2 and T3

    Language will be measured through a sentence-picture matching task and language production task. Changes in language will be calculated between timepoint 1 (T1), timepoint 2 (T2) and timepoint 3 (T3).

    From T1 to T2 (11 weeks for the experimental and active control arms, 9 weeks for the no-contact arm) and to T3 (8 weeks after T2)

  • Changes in quality of life from T1 to T2 and T3

    Quality of life will be measured through the Quality of Life in Neurological Disorders measure. Changes in quality of life will be calculated between timepoint 1 (T1), timepoint 2 (T2) and timepoint 3 (T3).

    From T1 to T2 (11 weeks for the experimental and active control arms, 9 weeks for the no-contact arm) and to T3 (8 weeks after T2)

Study Arms (3)

Music Based Intervention

EXPERIMENTAL

Participants in this arm will participate in the music intervention. For this intervention, participants will work with a music therapist and attend to music for 30 minutes each day over the course of 10 weeks.

Behavioral: Music-Based Therapy for Post Stroke Aphasia

Audiobook listeners

ACTIVE COMPARATOR

Participants in this arm will participate in the audiobook intervention. For this intervention, participants will work with a speech-language pathologist and attend to audiobooks for 30 minutes each day over the course of 10 weeks.

Behavioral: Audiobook Intervention for Post Stroke Aphasia

No Contact Control

NO INTERVENTION

The no-contact control arm is designed to demonstrate that any behavioral changes observed in the experimental (MBI) arm are due to the intervention itself, rather than spontaneous recovery processes. While PWA did not achieve full recovery through spontaneous processes, they may still experience improvements over time that occur independently of therapeutic interventions. The use of a no-contact control arm allows us to determine whether any changes observed in the experimental arm exceed those that might naturally occur without participation in the intervention.

Interventions

Participants will be instructed to maintain their usual activities each day, except we will ask them to select a time of day, a comfortable and distraction free environment, and an apparatus for regular music listening (earbuds, headphones, speakers). Participants will listen mindfully to randomized selections from the playlist that meets their needs that day (i.e., energizing or relaxing). Participants will listen to their music selections on shuffle for 30 minutes per day for 8 weeks using the strategies provided by the music therapist. The target listening duration is 30 minutes as it is a common target for time spent on task before taking a break. Participants will complete their daily journal entry immediately after music listening. The music therapist will make a weekly telephone call to each participant in the experimental arm. The telephone call will last \~30 minutes. During this telephone call, the music therapist will update the music playlists and help submit their logs.

Music Based Intervention

Participants will be instructed to maintain their usual activities each day, except we will ask them to select a time of day, a comfortable and distraction free environment, and an apparatus for regular music listening (earbuds, headphones, speakers). Participants will listen mindfully to an audiobook selected with a speech-language pathologist (SLP). Participants will listen to their audiobook for 30 minutes per day for 8 weeks using the strategies provided by the SLP. The target listening duration is 30 minutes as it is a common target for time spent on task before taking a break. Participants will complete their daily journal entry immediately after audiobook listening. The SLP will make a weekly telephone call to each participant in the experimental arm. The telephone call will last \~30 minutes. During this telephone call, the SLP will update the audiobook library and help submit their logs.

Also known as: Active Control
Audiobook listeners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults at least 18 years of age Individuals who have had a stroke and are at least 6 month post stroke Individuals are able to answer 4 questions to determine ability to consent (What is your name, what is the day/date, where are you , and why are we having this conversation).
  • Have normal or corrected to normal hearing Have normal or corrected to normal vision Have no issues with color blindness Individuals who have at least mild aphasia on the Western Aphasia Battery Revised Speaks American English

You may not qualify if:

  • Individuals who have had a dementia diagnosis or attention disorder pre stroke will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Varkanitsa M, Godecke E, Kiran S. How Much Attention Do We Pay to Attention Deficits in Poststroke Aphasia? Stroke. 2023 Jan;54(1):55-66. doi: 10.1161/STROKEAHA.122.037936. Epub 2022 Dec 21.

    PMID: 36542078BACKGROUND
  • Dovorany N, Brannick S, Johnson N, Ratiu I, LaCroix AN. Happy and sad music acutely modulate different types of attention in older adults. Front Psychol. 2023 Jan 26;14:1029773. doi: 10.3389/fpsyg.2023.1029773. eCollection 2023.

    PMID: 36777231BACKGROUND

MeSH Terms

Conditions

AphasiaStrokeHemorrhagic StrokeIschemic StrokeLanguage

Condition Hierarchy (Ancestors)

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

Study Officials

  • Arianna N LaCroix, PhD

    Purdue University Speech, Language, and Hearing Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily L Bauman, MS

CONTACT

Sandy A Snyder, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 25, 2025

First Posted

September 30, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

This project will generate behavioral data from one standardized language test, one 5 minute monologue, one experimental task of attention, one experimental task measuring language comprehension, one questionnaire regarding quality of life, and two questionnaires that assess participants' engagement and types of rewards experienced from music. All measures will be collected from all study participants pre- and post-intervention, and eight-weeks after the intervention concludes. The behavioral data will include verbal and written responses from the standardized tests and questionnaires, and reaction time and accuracy data from the experimental tasks. The standardized test and monologue will be videotaped. All de-identified data will be shared. We will not share the videotapes of the monologues as this information is identifiable.