NCT02875938

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

August 10, 2016

Last Update Submit

September 18, 2019

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)

    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

music with sung lyrics simultaneously with silent reading of the lyrics.

Music and reading lyrics

priming with music and sung lyrics followed by reading of the 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) 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carilion Franklin Memorial Hospital

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, MS, CCC-SLP

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 23, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations