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Completed

NCT Number: NCT02875938

Effect of Music on Reading Comprehension for Patients With Aphasia

This investigation uses a single-subject, adapted alternating research design to compare two different experimental conditions using music with lyrics combined with visual stimulation of the written lyrics, to extend the emotional word effect to phrases, in order to stimulate reading comprehension of the trained material for patients with aphasia. The two music conditions include 1) music with sung lyrics simultaneously with silent reading of the written lyrics; and 2) music with sung lyrics, followed by silent reading of the written lyrics (i.e. priming with the music). A control set without music will be used additionally within every third session to detect potential history and maturation effects. All conditions will be followed by a silent reading phrase-completion task composed of written words from the total combined sets of stimuli.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carilion Franklin Memorial Hospital

Rocky Mount, Virginia, 24151, United States

About this study

The purpose of this investigation is to examine the evidence on emotion, language, and music, and propose a first step, in the form of a single-subject research design, to determine the most effective and efficient method for application to the rehabilitation of patients with aphasia. A single-subject adapted alternating treatment design will be used to compare two music conditions, using music with sung lyrics simultaneously with silent reading of the lyrics, and priming with music and sung lyrics followed by reading of the lyrics, with a control condition using reading materials without music. Risks are expected to be minimal. The risk is confidentiality. Risk management procedures in this study include: assuring confidentiality of participants, assuring qualified personnel, assuring convenient location, ensuring adequate enrollment, continual monitoring, addressing potential conflicts of interest, and making a plan to manage problems. Continual monitoring will be used to assess whether study interventions appear to be interfering with normal speech therapy treatment. If the researcher sees any signs of interference, the subject will be withdrawn from the research and study interventions will be stopped.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-hospitalization;
  • premorbid reading at the 8th grade level or higher based on the participant's/family's stated years of formal education;
  • post-stroke aphasia/left middle cerebral artery (MCA) CVA based on electronic medical record (EMR) and computed tomography (CT)/magnetic resonance imaging (MRI) imaging reports, or consult with the neurologist;
  • intact left amygdala and left extrastriate cortex based on EMR and CT/MRI imaging reports, or consult with the neurologist;
  • reliability in answering yes/no questions as determined by a 90% score on yes/no comprehension therapy tasks during regular speech therapy.

Capacity to provide informed consent concerning a study involving an intervention with music therapy: determined by the physician who refers the patient.

Exclusion criteria

  • Co-morbidities diagnosed and reported in the EMR or shown on CT scan or MRI including past history of stroke with residual symptoms, dementia, Parkinson's disease, head injury, etc.;
  • hemianopsia or other visual field defects affecting vision for reading, and in particular right homonymous hemi- or inferior quadrantanopsia;
  • previous history of learning disabilities in reading/writing;
  • significant psychiatric diagnosis;
  • English as a Second Language or non-English language.

Treatment and study plan

Simultaneous music and reading lyrics

Behavioral

music with sung lyrics simultaneously with silent reading of the lyrics.

Priming with music

Behavioral

priming with music and sung lyrics followed by reading of the lyrics.

Control

Behavioral

control condition using reading materials without music.

Primary outcomes

  1. Percent correct responses per day on phrase completion task.

    Time frame: through study completion, an average of 1 year

    Differential response to the interventions (counted as the percent correct responses per day.

  2. Number of sessions required to achieve mastery.

    Time frame: through study completion, an average of 1 year

    count number of sessions.

  3. Retention of the reading material

    Time frame: 3 weeks post-intervention.

    Number of items recalled.

Secondary outcomes

  1. International Classification of Functioning, Disability, and Health (ICF) Body Functions/Structures, Activities, and Participation

    Time frame: through study completion, an average of 1 year

    Pretest/post-test information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al. 2011).

  2. Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3)

    Time frame: through study completion, an average of 1 year

    The Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.): Pretest reading scores on the BDAE full version subtests, i.e. B. Word Identification: 1. Word-Picture Match, and 2. Lexical Decision; C. 1. Homophone Matching; D. Derivational and Grammatical Morphology: 1. Matching to spoken sample; E. Oral Reading: 1. Basic oral word reading; F. Oral Reading of Sentences with Comprehension; and G. Reading Comprehension-Sentences and Paragraphs; will be completed prior to baseline A and initiating intervention, and immediately following completion of intervention to assess generalization to non-trained stimuli.

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Registry information

Acronym: EMRA1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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