Clinical trial NCT03608904: Stroke Recovery and Music or No Music
Official title: A Quantitative Connectivity Assessment of Music Listening Compared to Spoken Word in Ischemic Stroke Recovery, as Measured by Functional MRI (fMRI).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: Stroke
Music
Ischemic Stroke
fMRI
functional MRI
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Houston Methodist Centers of Performing Arts Medicine
First posted: 2018-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be exposed to music or no music (spoken words only) during their fMRI scans.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Ischemic Stroke 30 days to 5 years days prior to enrollment
2. Age 18-90
3. 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)
4. A measureable deficit either in motor or speech/cognition that can be assessed using standardized testing
5. Fluency in English (written and verbal)
6. Demonstrates willingness to participate in study and complete all schedule of events

Exclusion Criteria:

1. Severe cognitive impairment, as determined by investigator using the baseline MoCA score
2. Comorbid neurological disease that may interfere with rehabilitation
3. Psychiatric disorder or taking psychoactive medication that may interfere with completing study
4. Inability to complete music listening exercises
5. Alcohol or drug abuse
6. Hearing impairment
7. Contraindication to scheduled fMRI Brain evaluations
8. Pregnant women

Primary outcomes:
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.
timeFrame: Change from Baseline to Days 45 and 90
Secondary outcomes:
measure: Change in Motor Function Test Pinch Grip (pounds) at Baseline as Compared to Post-Listening Exposure at Day 45 and Day 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Motor Function Test Grip Strength (pounds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Grooved Pegboard Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Action Research Arm Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Timed Up and Go (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in 10 Meter Walk Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Modified Rankin Score (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in National Institutes of Health Stroke Scale (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: 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.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Albert's Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: 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.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation MAST (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation MAE Token Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Boston Naming Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Phonemic Fluency (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Semantic fluency (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Wide Range Achievement Test-4 Reading (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Trail Making Test-A (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Trail Making Test-B (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Hopkins Verbal Learning Test-Revised (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Brief Visuospatial Memory Test-Revised (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Clock Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Beck Depression Inventory-II (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: Change in Neuropsychological Evaluation Generalized Anxiety Disorder 7-item(score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.
timeFrame: Change from Baseline to Days 45 and 90
measure: 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.
timeFrame: Change from Baseline to Days 45 and 90
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: John J Volpi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.