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Trial record 16 of 243 for:    "Aphasia"

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

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ClinicalTrials.gov Identifier: NCT02875938
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Carilion Clinic

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.

Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Simultaneous music and reading lyrics Behavioral: Priming with music Behavioral: Control Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Music on Reading Comprehension for Patients With Aphasia
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia
U.S. FDA Resources

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: 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.
Behavioral: Control
control condition using reading materials without music.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875938


Locations
United States, Virginia
Carilion Franklin Memorial Hospital
Rocky Mount, Virginia, United States, 24151
Sponsors and Collaborators
Carilion Clinic
Investigators
Principal Investigator: Jacqueline A. Treichler, MS, CCC-SLP Carilion Clinic

Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT02875938     History of Changes
Other Study ID Numbers: CarilionClinic
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Carilion Clinic:
left middle cerebral artery
cerebrovascular accident (CVA)
stroke

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms