Stroke Recovery and Music or No Music
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 8/3/2018 |
| Start Date: | July 21, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Jonathan Wiese, MSN, RN |
| Email: | jrwiese@houstonmethodist.org |
| Phone: | 713-441-7161 |
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.
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.
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.
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.
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
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