AphasiaNCT03600987
Effect of Music on Reading Comprehension in Patients With Aphasia
A study testing Simultaneous music and reading lyrics and Priming with music in people with Aphasia, run by Carilion Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Simultaneous music and reading lyrics and Priming with music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 17 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Franklin Memorial Hospital, Carilion Community Memorial Hospital Inpatient Rehab, Carilion Day Rehab
Rocky Mount, Virginia, 24151
About this study
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.
Read the 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
- Being tested
- Simultaneous music and reading lyrics, Priming with music, Control
- Keywords
- left middle cerebral artery, cerebrovascular accident (CVA), stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous music and reading lyricsBehavioural
listening to music with singing of the lyrics simultaneously with reading the written lyrics.
Priming with musicBehavioural
priming by listening to music and singing of the lyrics followed by reading the written lyrics.
ControlBehavioural
control condition using reading materials without music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simultaneous music and reading lyrics; Behavioral: Priming with music; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct responses per day on phrase completion task.
Differential response to the interventions (counted as the percent correct responses per day).
Measured: through study completion, an average of 1 year.
Number of sessions required to achieve mastery.
Count number of sessions.
Measured: through study completion, an average of 1 year.
Retention of the reading material.
Number of items recalled.
Measured: 3 weeks post-intervention.
Secondary outcomes (2)
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).
Measured: through study completion, an average of 1 year.
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.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start18 Oct 2017
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject adapted alternating treatment design.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Treichler, Carilion Clinic
- Investigators
- Jacqueline A. Treichler, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600987
- Sponsor's protocol ID
- IRB #2408
- Status last verified
- Jan 2020
- First submitted
- 17 Jul 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share results without sharing protected health information or participant identification.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Reading Comprehension in Patients With Aphasia
- ClinicalTrials.gov ID
- NCT03600987
- Acronym / sponsor ID
- IRB #2408
- Conditions
- Aphasia
- Keywords
- left middle cerebral artery, cerebrovascular accident (CVA), stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject adapted alternating treatment design.
| Arm | Type | Receives |
|---|---|---|
| Music and reading lyrics | Experimental | Behavioral: Simultaneous music and reading lyrics, Behavioral: Priming with music, Behavioral: ControlA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous music and reading lyricslistening to music with singing of the lyrics simultaneously with reading the written lyrics. | Behavioural | Music and reading lyrics |
| Priming with musicpriming by listening to music and singing of the lyrics followed by reading the written lyrics. | Behavioural | Music and reading lyrics |
| Controlcontrol condition using reading materials without music. | Behavioural | Music and reading lyrics |
Primary outcome
Percent correct responses per day on phrase completion task.
Time frame: through study completion, an average of 1 year.
Differential response to the interventions (counted as the percent correct responses per day).
Number of sessions required to achieve mastery.
Time frame: through study completion, an average of 1 year.
Count number of sessions.
Retention of the reading material.
Time frame: 3 weeks post-intervention.
Number of items recalled.
2 secondary outcomes
International Classification of Functioning, Disability, and Health (ICF) body Functions/Structures, Activities, and Participation.
Time frame: through study completion, an average of 1 year.
Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.).
Time frame: through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No. Share results without sharing protected health information or participant identification.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline A. Treichler principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous music and reading lyrics and Priming with music in people with Aphasia, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent correct responses per day on phrase completion task. (time frame: through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.