Effect of Music on Reading Comprehension for Patients With Aphasia (EMRA1)

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.

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Control; Behavioral: Simultaneous music and reading lyrics; Behavioral: Priming with music

Detailed Description

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 If the researcher sees any signs of interference, the subject will be withdrawn from the research and study interventions will be stopped.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Rocky Mount, Virginia, United States, 24151
      • Carilion Franklin Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music and reading lyrics; 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.	Behavioral: Control; control condition using reading materials without music.; Behavioral: Simultaneous music and reading lyrics; music with sung lyrics simultaneously with silent reading of the lyrics.; Behavioral: Priming with music; priming with music and sung lyrics followed by reading of the lyrics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent correct responses per day on phrase completion task.	Differential response to the interventions (counted as the percent correct responses per day.	through study completion, an average of 1 year
Number of sessions required to achieve mastery.	count number of sessions.	through study completion, an average of 1 year
Retention of the reading material	Number of items recalled.	3 weeks post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Classification of Functioning, Disability, and Health (ICF) Body Functions/Structures, Activities, and Participation	Pretest/post-test information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al. 2011).	through study completion, an average of 1 year
Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3)	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Jacqueline A. Treichler, MS, CCC-SLP, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: stroke; cerebrovascular accident (CVA); left middle cerebral artery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: CarilionClinic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO