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

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simultaneous music and reading lyrics
Priming with music
Control
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring left middle cerebral artery, cerebrovascular accident (CVA), stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carilion Franklin Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music and reading lyrics

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent correct responses per day on phrase completion task.
Differential response to the interventions (counted as the percent correct responses per day.
Number of sessions required to achieve mastery.
count number of sessions.
Retention of the reading material
Number of items recalled.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
August 10, 2016
Last Updated
September 18, 2019
Sponsor
Carilion Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02875938
Brief Title
Effect of Music on Reading Comprehension for Patients With Aphasia
Acronym
EMRA1
Official Title
Effect of Music on Reading Comprehension for Patients With Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
left middle cerebral artery, cerebrovascular accident (CVA), stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music and reading lyrics
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Simultaneous music and reading lyrics
Intervention Description
music with sung lyrics simultaneously with silent reading of the lyrics.
Intervention Type
Behavioral
Intervention Name(s)
Priming with music
Intervention Description
priming with music and sung lyrics followed by reading of the lyrics.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
control condition using reading materials without music.
Primary Outcome Measure Information:
Title
Percent correct responses per day on phrase completion task.
Description
Differential response to the interventions (counted as the percent correct responses per day.
Time Frame
through study completion, an average of 1 year
Title
Number of sessions required to achieve mastery.
Description
count number of sessions.
Time Frame
through study completion, an average of 1 year
Title
Retention of the reading material
Description
Number of items recalled.
Time Frame
3 weeks post-intervention.
Secondary Outcome Measure Information:
Title
International Classification of Functioning, Disability, and Health (ICF) Body Functions/Structures, Activities, and Participation
Description
Pretest/post-test information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al. 2011).
Time Frame
through study completion, an average of 1 year
Title
Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3)
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline A. Treichler, MS, CCC-SLP
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Franklin Memorial Hospital
City
Rocky Mount
State/Province
Virginia
ZIP/Postal Code
24151
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Music on Reading Comprehension for Patients With Aphasia

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