Effect of Music on Reading Comprehension in Patients With Aphasia

Aphasia Clinical Trial

Official title:

Effect of Music on Reading Comprehension in Patients With Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600987
• Other study ID #: IRB #2408
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: October 17, 2019

Study information

• Verified date: January 2020
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 reading of the lyrics, and priming with music and sung lyrics followed by a reading of the lyrics, with a control condition using reading lyrics without music. Results are expected to provide evidence of independent versus shared processing of music and language at the phrase level applied to the behavior of human subjects with aphasia.

Description:

Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Data verification to assess the accuracy, completeness, or representativeness of data by comparing the data to external data sources (reliability) Data dictionary: detailed descriptions of each variable Standard Operating Procedures: patient recruitment, data collection, data management, data analysis, reporting for adverse events change management. Sample size: A minimum of four participants will be required to demonstrate replication of treatment effects. A maximum of ten participants will be requested to account for attrition.

Plan for missing data, data inconsistency,or out-of-range results. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• 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) cerebral vascular accident (CVA) based on electronic medical record (EMR) and computed tomography (CT) and/or 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 an 80% score on 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 in other brain regions with residual symptoms, dementia, Parkinson 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
listening to music with singing of the lyrics simultaneously with reading the written lyrics.
• Priming with music
priming by listening to music and singing of the lyrics followed by reading the written lyrics.
• Control
control condition using reading materials without music.

Locations

Country	Name	City	State
United States	Carilion Franklin Memorial Hospital, Carilion Community Memorial Hospital Inpatient Rehab, Carilion Day Rehab	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-posttest 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) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.).	BDAE-3 pretest-posttest reading scores on subtests: Word Identification/Word-Picture Match and Lexical Decision; Homophone Matching; Derivational and Grammatical Morphology/Matching to spoken sample; Oral Reading/Basic oral word reading; Oral Reading of Sentences with Comprehension; and Reading Comprehension-Sentences and Paragraphs. Pretest will be completed prior to baseline and initiating intervention, and posttest with be completed immediately following completion of intervention to assess generalization to non-trained stimuli.	through study completion, an average of 1 year.