Ischemic StrokeNCT03608904
Stroke Recovery and Music or No Music
A study testing Music listening and Spoken word (language) listening in people with Ischemic Stroke, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The primary outcome of this study is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline in patients with ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Music listening and Spoken word (language) listening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 31 Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic Stroke 30 days to 5 years days prior to enrollment
- Age 18-90
- Modified Rankin Score (mRS) 1-3, inclusive, post-qualifying event (for a history of multiple strokes, baseline mRS is 0-1 AND a lower value than the qualifying mRS)
- A measureable deficit either in motor or speech/cognition that can be assessed using standardized testing
- Fluency in English (written and verbal)
- Demonstrates willingness to participate in study and complete all schedule of events
Who cannot join
- Severe cognitive impairment, as determined by investigator using the baseline MoCA score
- Comorbid neurological disease that may interfere with rehabilitation
- Psychiatric disorder or taking psychoactive medication that may interfere with completing study
- Inability to complete music listening exercises
- Alcohol or drug abuse
- Hearing impairment
- Contraindication to scheduled fMRI Brain evaluations
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist
Houston, Texas, 77030
John J Volpi, MD
About this study
Official title: A Quantitative Connectivity Assessment of Music Listening Compared to Spoken Word in Ischemic Stroke Recovery, as Measured by Functional MRI (fMRI).
The primary outcome of this study is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline in patients with ischemic stroke. Eligible patients will receive a listening session of music or spoken word listening, 30 days to 5 years following ischemic stroke. Assessments will include modified Rankin Scale, National Institute of Health Stroke Scale, functional Magnetic Resonance Imaging, motor function tests, and neuropsychological evaluations. Assessments occur at baseline, day 45, and day 90 after starting listening sessions.
Read the detailed description
This is a prospective, investigator-blinded and outcome assessor-blinded, randomized, single-center study in subjects 18-90 years old who have sustained an ischemic stroke within 30 days to 5 years. Study subjects will be randomized 1:1 to receive one of two types of listening sessions: music or spoken word (language) listening. Each arm will enroll a total of ten subjects, with a total study population of 20 subjects. Subjects will follow a 90-day listening schedule.
Subjects will complete a baseline Montreal Cognitive Assessment (MoCA), National Institute of Health Stroke Scale (NIHSS), modified Rankin Score (mRS), motor function tests, neuropsychological evaluations and functional magnetic resonance imaging (fMRI) brain evaluation. Follow-up evaluations on day 45 (+/- 7 days) and on day 90 (+/-7days) and will include NIHSS/mRS, motor function tests, neuropsychological evaluations and fMRI Brain evaluation.
All subjects will continue to receive standard of care treatment for stroke as directed by their physician(s) regardless of study enrollment.
The primary objective is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline.
The secondary objectives include the effect of music and language listening in improving motor function and neuropsychological development in patients with an ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- Music listening, Spoken word (language) listening
- Keywords
- Stroke, Music, Ischemic Stroke, fMRI, functional MRI
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
Familiar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.
Spoken word (language) listeningOther
Familiar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.
| Study group | Role | What they receive |
|---|---|---|
| Music Listening | Experimental | Familiar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration. Receives: Other: Music listening |
| Spoken word (language) listening | Placebo comparator | Familiar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration. Receives: Other: Spoken word (language) listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Connectivity as Measured by Functional Magnetic Resonance Imaging (fMRI) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To determine quantitative increase in connectivity of music and/or spoken word (language) listening, as measured by fMRI brain, and calculated as a percent increase from baseline.
Measured: Change from Baseline to Days 45 and 90
Secondary outcomes (25)
Change in Motor Function Test Pinch Grip (pounds) at Baseline as Compared to Post-Listening Exposure at Day 45 and Day 90.
To assess the effect of music and/or spoken word (language) listening in improving motor function test of pinch grip.
Measured: Change from Baseline to Days 45 and 90
Change in Motor Function Test Grip Strength (pounds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improving motor function test of grip strength.
Measured: Change from Baseline to Days 45 and 90
Change in Grooved Pegboard Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improving motor function test of grooved pegboard test.
Measured: Change from Baseline to Days 45 and 90
Change in Action Research Arm Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improving motor function test of Action Research Arm Test (ARAT).
Measured: Change from Baseline to Days 45 and 90
Change in Timed Up and Go (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improving motor function test of Timed Up and Go.
Measured: Change from Baseline to Days 45 and 90
Change in 10 Meter Walk Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improving motor function test of 10 meter walk test.
Measured: Change from Baseline to Days 45 and 90
Change in Modified Rankin Score (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of disability score.
Measured: Change from Baseline to Days 45 and 90
Change in National Institutes of Health Stroke Scale (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of standardized stroke score.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Wechsler Adult Intelligence Scale-IV: Digit Span (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvements of neuropsychology evaluation of an aural test of immediate attention and working memory.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Albert's Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a line cancellation test of visual attention/neglect.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Rey Complex Figure Test and Recognition Trial (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a drawing test used to assess planning, organization and visual-spatial skills.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation MAST (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a language measure for patients with aphasia.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation MAE Token Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of an aural language comprehension measure.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Boston Naming Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a test of confrontation naming.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Phonemic Fluency (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a generative naming test.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Semantic fluency (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a generative naming test.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Wide Range Achievement Test-4 Reading (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a single-word reading measure that can be used, in some, to assess premorbid intellectual abilities.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Trail Making Test-A (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in changes of a neuropsychology evaluation of a speeded psychomotor test of attention.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Trail Making Test-B (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a speeded psychomotor test of alternating attention/working memory.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Hopkins Verbal Learning Test-Revised (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in changes of a neuropsychology evaluation of a rote verbal learning and test.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Brief Visuospatial Memory Test-Revised (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a visual learning and memory test.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Clock Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a measure of conceptualization, planning, organization, and visual-spatial skills.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Beck Depression Inventory-II (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a test to measure depression.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Generalized Anxiety Disorder 7-item(score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a test to measure generalized anxiety.
Measured: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation The Stroke-Adapted Sickness Impact Profile (SA-SIP30) (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
To assess the effect of music and/or spoken word (language) listening in improvement of neuropsychology evaluation of a post-stroke quality of life measure.
Measured: Change from Baseline to Days 45 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start21 Jul 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be exposed to music or no music (spoken words only) during their fMRI scans.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Houston Methodist Centers of Performing Arts Medicine
- Responsible party
- Principal investigator, John J. Volpi, MD, The Methodist Hospital Research Institute
- Investigators
- John J Volpi, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608904
- Sponsor's protocol ID
- Pro00015563
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans at to share individual subject data at this time.
Publications
Karmonik C, Brandt A, Anderson J, Brooks F, Lytle J, Silverman E, Frazier JT. Music Listening modulates Functional Connectivity and Information Flow in the Human Brain. Brain Connect. 2016 Oct;6(8):632-641. doi: 10.1089/brain.2016.0428. Epub 2016 Jul 27.
PubMed 27464741
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative Connectivity Assessment of Music Listening Compared to Spoken Word in Ischemic Stroke Recovery, as Measured by Functional MRI (fMRI).
- ClinicalTrials.gov ID
- NCT03608904
- Acronym / sponsor ID
- Pro00015563
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Music, Ischemic Stroke, fMRI, functional MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Houston Methodist Centers of Performing Arts Medicine
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Aug 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 primary outcome of this study is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline in patients with ischemic stroke. Eligible patients will receive a listening session of music or spoken word listening, 30 days to 5 years following ischemic stroke. Assessments will include modified Rankin Scale, National Institute of Health Stroke Scale, functional Magnetic Resonance Imaging, motor function tests, and neuropsychological evaluations. Assessments occur at baseline, day 45, and day 90 after starting listening sessions.
Detailed description
This is a prospective, investigator-blinded and outcome assessor-blinded, randomized, single-center study in subjects 18-90 years old who have sustained an ischemic stroke within 30 days to 5 years. Study subjects will be randomized 1:1 to receive one of two types of listening sessions: music or spoken word (language) listening. Each arm will enroll a total of ten subjects, with a total study population of 20 subjects. Subjects will follow a 90-day listening schedule.
Subjects will complete a baseline Montreal Cognitive Assessment (MoCA), National Institute of Health Stroke Scale (NIHSS), modified Rankin Score (mRS), motor function tests, neuropsychological evaluations and functional magnetic resonance imaging (fMRI) brain evaluation. Follow-up evaluations on day 45 (+/- 7 days) and on day 90 (+/-7days) and will include NIHSS/mRS, motor function tests, neuropsychological evaluations and fMRI Brain evaluation.
All subjects will continue to receive standard of care treatment for stroke as directed by their physician(s) regardless of study enrollment.
The primary objective is to determine the quantitative increase in connectivity, as measured by fMRI brain and calculated as a percent increase from baseline.
The secondary objectives include the effect of music and language listening in improving motor function and neuropsychological development in patients with an ischemic stroke.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be exposed to music or no music (spoken words only) during their fMRI scans.
| Arm | Type | Receives |
|---|---|---|
| Music Listening | Experimental | Other: Music listeningFamiliar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration. |
| Spoken word (language) listening | Placebo comparator | Other: Spoken word (language) listeningFamiliar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic Stroke 30 days to 5 years days prior to enrollment
- Age 18-90
- Modified Rankin Score (mRS) 1-3, inclusive, post-qualifying event (for a history of multiple strokes, baseline mRS is 0-1 AND a lower value than the qualifying mRS)
- A measureable deficit either in motor or speech/cognition that can be assessed using standardized testing
- Fluency in English (written and verbal)
Key exclusion criteria (8 listed)
- Severe cognitive impairment, as determined by investigator using the baseline MoCA score
- Comorbid neurological disease that may interfere with rehabilitation
- Psychiatric disorder or taking psychoactive medication that may interfere with completing study
- Inability to complete music listening exercises
- Alcohol or drug abuse
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 |
|---|---|---|
| Music listeningFamiliar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration. | Other | Music Listening |
| Spoken word (language) listeningFamiliar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration. | Other | Spoken word (language) listening |
Primary outcome
Change in Connectivity as Measured by Functional Magnetic Resonance Imaging (fMRI) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
To determine quantitative increase in connectivity of music and/or spoken word (language) listening, as measured by fMRI brain, and calculated as a percent increase from baseline.
25 secondary outcomes
Change in Motor Function Test Pinch Grip (pounds) at Baseline as Compared to Post-Listening Exposure at Day 45 and Day 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Motor Function Test Grip Strength (pounds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Grooved Pegboard Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Action Research Arm Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Timed Up and Go (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in 10 Meter Walk Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Modified Rankin Score (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in National Institutes of Health Stroke Scale (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Wechsler Adult Intelligence Scale-IV: Digit Span (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Albert's Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Rey Complex Figure Test and Recognition Trial (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation MAST (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation MAE Token Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Boston Naming Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Phonemic Fluency (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Semantic fluency (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Wide Range Achievement Test-4 Reading (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Trail Making Test-A (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Trail Making Test-B (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Hopkins Verbal Learning Test-Revised (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Brief Visuospatial Memory Test-Revised (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Clock Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Beck Depression Inventory-II (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation Generalized Anxiety Disorder 7-item(score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Change in Neuropsychological Evaluation The Stroke-Adapted Sickness Impact Profile (SA-SIP30) (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
Time frame: Change from Baseline to Days 45 and 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 27464741Karmonik C, Brandt A, Anderson J, Brooks F, Lytle J, Silverman E, Frazier JT. Music Listening modulates Functional Connectivity and Information Flow in the Human Brain. Brain Connect. 2016 Oct;6(8):632-641. doi: 10.1089/brain.2016.0428. Epub 2016 Jul 27.
- Individual participant dataSharing planned: No. No plans at to share individual subject data at this time.
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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.
John J Volpi, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening and Spoken word (language) listening in people with Ischemic Stroke, run by The Methodist Hospital Research Institute 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 8 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Wiese, MSN, RN (713-441-7161, jrwiese@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Connectivity as Measured by Functional Magnetic Resonance Imaging (fMRI) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90. (time frame: Change from Baseline to Days 45 and 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608904, which also lists 1 linked publication.
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 1 Aug 2018.