Effect of Music on Reading Comprehension for Patients With Aphasia

Aphasia Clinical Trial

— EMRA1  

Official title:

Effect of Music on Reading Comprehension for Patients With Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875938
• Other study ID #: CarilionClinic
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2019
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• Simultaneous music and reading lyrics
music with sung lyrics simultaneously with silent reading of the lyrics.
• Priming with music
priming with music and sung lyrics followed by reading of the lyrics.
• Control
control condition using reading materials without music.

Locations

Country	Name	City	State
United States	Carilion Franklin Memorial Hospital	Rocky Mount	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of sessions required to achieve mastery.	count number of sessions.	through study completion, an average of 1 year
Primary	Retention of the reading material	Number of items recalled.	3 weeks post-intervention.
Secondary	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
Secondary	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