Clinical trial NCT04441515: Music After Stroke To Enhance Rehabilitation
Official title: Music After Stroke To Enhance Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Expressive Aphasia
Movement, Abnormal
Depressive Disorder
Lead sponsor: Pace University
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2020-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Music that is familiar and preferred by patients has been shown to heighten neuroplasticity and can mitigate these disabilities. Therefore, this study seeks to explore the effect of providing patient preferred music to patients in the very early post stroke period (within 24 hours of a left cerebral artery stroke \[LMCA\]event) as a complementary modality to usual stroke care.

Detailed description: Aim I. The primary aim of MASTER is to identify whether a potential relationship exists between an intervention of participant preferred music, when initiated within the first 24 hours following a left middle cerebral artery stroke, and a reduction in the following disabilities: Expressive aphasia, right hand functional deficit and post stroke depression. This aim will serve to address the first research hypothesis and address the relationship between These disabilities are well known sequalae among patients diagnosed with the most common form of stroke, a LMCA stroke. Participant preferred music within the first 24 hours following a LMCA stroke and a reduction in: Expressive aphasia, right hand functional deficit and post stroke depression, as these disabilities are well known sequalae among LMCA stroke patients.

Aim II. The second aim of MASTER is to identify if a relationship exists between an intervention of audible books, when initiated within the first 24 hours following a LMCA stroke, and a reduction in the following disabilities: Expressive aphasia, right hand functional deficit and post stroke depression.

Sufficient evidence exists to suggest that although listening to books stimulates cognitive function, the effect of melody and participant engagement in music is far superior to listening to words alone as the inherent rhythmicity of patient-favored music has been shown to strengthen synchronous neuronal connectivity, by modulating dopamine and inducing fine grained neuroanatomical changes in a recovering brain.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of LMCA stroke within prior 24 hours
* Not identified as critically ill
* Glascow Coma Scale \> 8 at time of consent
* Resident of a home with a land line or cell phone
* Able to speak in English or Spanish prior to stroke event
* Presence of expressive aphasia at time of enrollment.

Exclusion Criteria:

* Stroke diagnosis other than LMCA territory stroke
* Unable to provide consent by patient or legally accountable person acting on behalf of the patient (healthcare proxy, healthcare power of attorney), Patient/ representative
* Does not speak English or Spanish prior to stroke event
* Have a diagnosis of end stage cancer, or other medical conditions that dramatically increase a risk of mortality within one year
* Any pre-existing communication disorder (including dementia)
* Patients that are deemed critically ill will not be included

Primary outcomes:
measure: expressive aphasia measured by use of the WAB-R
timeFrame: 6 months
measure: motor activity right hand as measured using the Motor Activity log
timeFrame: 6 months
measure: Depressive symptoms as measured using the PHQ-9
timeFrame: 6 months
measure: Quality of life as measured using the 20 item short form survey (SF-20)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pace University
name: Millie Hepburn, PhD
role: PRINCIPAL_INVESTIGATOR
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