Effect of Music on Reading Comprehension in Patients With Aphasia

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.

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.