Stroke Recovery and Music or No Music

NCT03608904 | Unknown

• 1 other identifier: Pro00015563
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Music; Ischemic Stroke; fMRI; functional MRI

Outcome Measures

Primary Outcomes (1)

• Change in Connectivity as Measured by Functional Magnetic Resonance Imaging (fMRI) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.

  To determine quantitative increase in connectivity of music and/or spoken word (language) listening, as measured by fMRI brain, and calculated as a percent increase from baseline.

  Change from Baseline to Days 45 and 90

Secondary Outcomes (25)

• Change in Motor Function Test Pinch Grip (pounds) at Baseline as Compared to Post-Listening Exposure at Day 45 and Day 90.

  Change from Baseline to Days 45 and 90

• Change in Motor Function Test Grip Strength (pounds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.

  Change from Baseline to Days 45 and 90

• Change in Grooved Pegboard Test (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.

  Change from Baseline to Days 45 and 90

• Change in Action Research Arm Test (score) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.

  Change from Baseline to Days 45 and 90

• Change in Timed Up and Go (seconds) at Baseline as Compared to Post-Listening Exposure at Days 45 and 90.

  Change from Baseline to Days 45 and 90

Study Arms (2)

Music Listening

EXPERIMENTAL

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

Other: Music listening

Spoken word (language) listening

PLACEBO COMPARATOR

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

Other: Spoken word (language) listening

Interventions

Music listening OTHER

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

Music Listening

Spoken word (language) listening OTHER

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

Spoken word (language) listening

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic Stroke 30 days to 5 years days prior to enrollment
• Age 18-90
• 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)
• A measureable deficit either in motor or speech/cognition that can be assessed using standardized testing
• Fluency in English (written and verbal)
• Demonstrates willingness to participate in study and complete all schedule of events

You may not qualify if:

• Severe cognitive impairment, as determined by investigator using the baseline MoCA score
• Comorbid neurological disease that may interfere with rehabilitation
• Psychiatric disorder or taking psychoactive medication that may interfere with completing study
• Inability to complete music listening exercises
• Alcohol or drug abuse
• Hearing impairment
• Contraindication to scheduled fMRI Brain evaluations
• Pregnant women

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Houston Methodist Centers of Performing Arts Medicine: collaborator

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 27464741 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Auditory Perception

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena

Study Officials

• John J Volpi, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Wiese, MSN, RN

CONTACT

713-441-7161; jrwiese@houstonmethodist.org

Paige McIntyre

CONTACT

713-363-9052; pmcintyre@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neurologist

Model Details: Participants will be exposed to music or no music (spoken words only) during their fMRI scans.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: August 1, 2018
• Study Start: July 21, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)