Clinical trial NCT02875938: Effect of Music on Reading Comprehension for Patients With Aphasia
Official title: Effect of Music on Reading Comprehension for Patients With Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: left middle cerebral artery
cerebrovascular accident (CVA)
stroke
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent correct responses per day on phrase completion task.
timeFrame: through study completion, an average of 1 year
measure: Number of sessions required to achieve mastery.
timeFrame: through study completion, an average of 1 year
measure: Retention of the reading material
timeFrame: 3 weeks post-intervention.
Secondary outcomes:
measure: International Classification of Functioning, Disability, and Health (ICF) Body Functions/Structures, Activities, and Participation
timeFrame: through study completion, an average of 1 year
measure: Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Rocky Mount
country: United States
facility: Carilion Franklin Memorial Hospital
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Jacqueline A. Treichler, MS, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: