Ischemic Stroke Clinical Trial
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.
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.
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