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临床试验/NCT07198048
NCT07198048尚未招募不适用

Treating Attention and Language in Post-stroke Aphasia Using a Music-based Intervention.

Purdue University0 个研究点目标入组 45 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
Change in attention from T1 to T2 and T3

研究概览

简要总结

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. Is a music based intervention effective at improving attention with someone who has aphasia?
  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.

Participants will:

  1. Listen to music or an audiobook for 30 minutes a day for 8 weeks
  2. Complete a daily journal about each day's listening experience
  3. Complete three testing sessions where attention, language, and quality of life are assessed.

详细描述

Participants: Participants will be 45 people with aphasia (PWA) who are a representative sample of the diversity of the Lafayette, Indiana area, and broader United States. We will recruit PWA from the PI's research registry, which includes ~60 PWA, Purdue's in-house Speech, Language, and Hearing clinics, local assisted living and rehabilitation hospitals, public community centers, and online. The PI has extensive experience recruiting from these sources and recently recruited 43 PWA for a similar study in one year. PWA will be included in the study if they are 18+ years of age, had a stroke at least 6 months prior to study enrollment, have normal or corrected to normal hearing and vision, no history of an attention disorder pre-stroke, and at least a mild aphasia on the Western Aphasia Battery Revised (WAB-R). Hearing acuity will be screened using pure tone audiometry at 500-4000 Hz. Vision will be assessed using self assessment Randomization to Study Arms: Participants will be randomly assigned to either the experimental arm, active control arm, or the no-contact control arm (n = 15 per arm). The study arms are adapted from a previous study in which acute stroke survivors listened to music, an audiobook, or no prescribed auditory material daily over an 8-week period. However, PWA are a distinct clinical population from acute stroke warranting a specific investigation into whether the MBI similarly impacts attention in PWA, and subsequently their language abilities and quality of life.

Experimental Arm: Receptive Music-Based Intervention In an initial one-hour meeting, a board-certified music therapist will work with each participant to assess their music preferences and curate two playlists using the Spotify Music app. One playlist will include highly energizing pieces. The second playlist will include relaxing pieces. The playlists will include music selected by the participant and music by the same or similar artists, instrumentation, or genres, and will be chosen in consultation with the music therapist. The lists will be of sufficient length to allow the selections to be shuffled for listening each day without repetition based on the previous day's listening.

In a second one-hour meeting, the music therapist will teach the participant listening techniques to help them attend closely to the music and observe its effects on their mind and body, including movements, associations, memories, images, breathing rate, and levels of relaxation or tension. The music therapist will also demonstrate how to enter these effects into their daily music listening journal, which will be completed after each listening session.

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 for the following week based on participant feedback. The music therapist will also inquire about the participant's daily music listening journals and help them submit their listening logs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Individuals who meet the inclusion criteria, but are unwilling to travel to the ABC Lab at Purdue University for in person testing and do not have a laptop or desktop with a web camera that they could participate online with, will be excluded.
  • Individuals who have had a dementia diagnosis or attention disorder pre stroke will be excluded.

结局指标

主要结局

Change in attention from T1 to T2 and T3

时间窗: 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)

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).

Change in language from T1 to T2 and T3

时间窗: 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)

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).

Changes in quality of life from T1 to T2 and T3

时间窗: 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)

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LaCroixLab

Assistant Professor

Purdue University

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