Recruiting

Music

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT03608904

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Music listening

Spoken word (language) listening

Study Details

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.

Conditions

Ischemic Stroke

Study ID

NCT03608904

Start date

Jul 21, 2017

Status verified date

Jul, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Music Listening

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

placebo comparator: Spoken word (language) listening

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

Interventions

Music listening

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

Spoken word (language) listening

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

Primary outcome 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. [ Time Frame: Change from Baseline to Days 45 and 90 ]

Central Contacts and Locations

Central contacts

Jonathan Wiese, MSN, RN

713-441-7161jrwiese@houstonmethodist.org

Paige McIntyre

713-363-9052pmcintyre@houstonmethodist.org

Locations

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Aug 1, 2018

Last verified

Jul, 2018

Keywords

  • Stroke
  • Music
  • Ischemic Stroke
  • fMRI
  • functional MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2018-08-01.