Stroke Recovery and Music or No Music

The Methodist Hospital Research Institute (TMHRI)

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Other: Spoken word (language) listening; Other: Music listening

Study type: Interventional

Funder types: Other

Identifiers

NCT03608904

Pro00015563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Music Listening

Experimental group

Description:

Familiar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.

Treatment:

Other: Music listening

Spoken word (language) listening

Placebo Comparator group

Description:

Familiar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.

Treatment:

Other: Spoken word (language) listening