NCT03600987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

July 17, 2018

Last Update Submit

January 2, 2020

Conditions

Keywords

left middle cerebral arterycerebrovascular accident (CVA)stroke

Outcome Measures

Primary Outcomes (3)

  • 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.

  • Number of sessions required to achieve mastery.

    Count number of sessions.

    through study completion, an average of 1 year.

  • Retention of the reading material.

    Number of items recalled.

    3 weeks post-intervention.

Secondary Outcomes (2)

  • International Classification of Functioning, Disability, and Health (ICF) body Functions/Structures, Activities, and Participation.

    through study completion, an average of 1 year.

  • Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.).

    through study completion, an average of 1 year.

Study Arms (1)

Music and reading lyrics

EXPERIMENTAL

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 lyricsBehavioral: Priming with musicBehavioral: Control

Interventions

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

Music and reading lyrics

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

Music and reading lyrics
ControlBEHAVIORAL

control condition using reading materials without music.

Music and reading lyrics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rocky Mount, Virginia, 24151, United States

Location

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jacqueline A. Treichler

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-subject adapted alternating treatment design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ClinScD, CCC-SLP; Speech-Language Pathologist

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

October 18, 2017

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Share results without sharing protected health information or participant identification.

Locations