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Music After Stroke To Enhance Rehabilitation (MASTER)

P

Pace University

Status

Unknown

Conditions

Expressive Aphasia
Stroke, Acute
Depressive Disorder
Movement, Abnormal

Treatments

Device: ipod only with usual care
Device: Ipod with music
Device: ipod with books to listen

Study type

Interventional

Funder types

Other

Identifiers

NCT04441515
MASTER1

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 3 patient groups, including a placebo group

Music
Experimental group
Description:
music supplied by ipod
Treatment:
Device: Ipod with music
oral books
Active Comparator group
Description:
Listening to books on ipod
Treatment:
Device: ipod with books to listen
usual care
Placebo Comparator group
Description:
Usual care
Treatment:
Device: ipod only with usual care

Trial contacts and locations

0

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Central trial contact

Lori Sutherly, MS; Millie Hepburn, PhD

Data sourced from clinicaltrials.gov

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