NCT03608904

Stroke Recovery and Music or No Music

A Quantitative Connectivity Assessment of Music Listening Compared to Spoken Word in Ischemic Stroke Recovery, as Measured by Functional MRI (fMRI).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Music listening	Familiar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.
OTHER	Spoken word (language) listening	Familiar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.

Timeline

• Start date: 2017-07-21
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-08-01
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States