Effect of Music on Reading Comprehension in Patients With Aphasia

NCT ID: NCT03600987

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2019-10-17

Brief 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.

Detailed 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.

Conditions

Aphasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Simultaneous music and reading lyrics

Intervention Type: BEHAVIORAL

listening to music with singing of the lyrics simultaneously with reading the written lyrics.

Priming with music

Intervention Type: BEHAVIORAL

priming by listening to music and singing of the lyrics followed by reading the written lyrics.

Control

Intervention Type: BEHAVIORAL

control condition using reading materials without music.

Interventions

Simultaneous music and reading lyrics

listening to music with singing of the lyrics simultaneously with reading the written lyrics.

Intervention Type: BEHAVIORAL

Priming with music

priming by listening to music and singing of the lyrics followed by reading the written lyrics.

Intervention Type: BEHAVIORAL

Control

control condition using reading materials without music.

Intervention Type: BEHAVIORAL

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) 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Treichler

ClinScD, CCC-SLP; Speech-Language Pathologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacqueline A. Treichler

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

Carilion Franklin Memorial Hospital, Carilion Community Memorial Hospital Inpatient Rehab, Carilion Day Rehab

Rocky Mount, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB #2408

Identifier Type: -

Identifier Source: org_study_id