Stroke Recovery and Music or No Music

NCT ID: NCT03608904

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-21
• Study Completion Date: 2019-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Music Listening

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

Group Type: EXPERIMENTAL

Music listening

Intervention Type: OTHER

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.

Group Type: PLACEBO_COMPARATOR

Spoken word (language) listening

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Houston Methodist Centers of Performing Arts Medicine

UNKNOWN

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

John J. Volpi, MD

Principal Investigator, Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John J Volpi, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Wiese, MSN, RN

Role: CONTACT

jrwiese@houstonmethodist.org

713-441-7161

Paige McIntyre

Role: CONTACT

pmcintyre@houstonmethodist.org

713-363-9052

Facility Contacts

John J Volpi, MD

Role: primary

References

Karmonik C, Brandt A, Anderson J, Brooks F, Lytle J, Silverman E, Frazier JT. Music Listening modulates Functional Connectivity and Information Flow in the Human Brain. Brain Connect. 2016 Oct;6(8):632-641. doi: 10.1089/brain.2016.0428. Epub 2016 Jul 27.

Reference Type: BACKGROUND

PMID: 27464741 (View on PubMed)

Other Identifiers

Pro00015563

Identifier Type: -

Identifier Source: org_study_id