NCT01749709

Brief Summary

Single blind randomized clinical trial including 50 stroke patients to investigate the effect of daily music listening on behavioral, neural and physiological recovery. Patients are randomized (1:1:1) to listen instrumental or vocal music, or audiobooks (recorded book reading) (control). Outcome measures are change in neuropsychological tests, change in self-reported mood, structural and functional magnetic resonance imaging changes and hormonal changes performed at acute, 3-month and 6-month stages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2016

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

3.3 years

First QC Date

December 12, 2012

Last Update Submit

December 31, 2021

Conditions

Stroke

Keywords

StrokeRecoveryMusic

Outcome Measures

Primary Outcomes (2)

  • Change in neuropsychological performance (verbal memory)

    Verbal memory summary score (Rivermead Behavioral Memory Test (RBMT) story recall, auditory-verbal learning task)

    From acute to 3-month-stage

  • Change in neuropsychological performance (verbal memory)

    Verbal memory summary score (RBMT story recall, auditory-verbal learning task)

    From acute to 6-month-stage

Secondary Outcomes (20)

  • Change in neuropsychological performance (Language skill)

    From acute to 3-month-stage

  • Change in neuropsychological performance (Language skill)

    From acute to 3-month-stage

  • Change in neuropsychological performance (Language skill)

    From acute to 3-month-stage

  • Change in neuropsychological performance (Language skill)

    From acute to 6-month-stages

  • Change in neuropsychological performance (Language skill)

    From acute to 6-month-stages

  • +15 more secondary outcomes

Study Arms (3)

Instrumental music listening

EXPERIMENTAL

Daily music listening

Behavioral: Music listening

Vocal music listening

EXPERIMENTAL

Daily music listening

Behavioral: Music listening

Audiobook listening (control)

ACTIVE COMPARATOR

Daily audiobook listening

Behavioral: Audiobook listening

Interventions

Music listeningBEHAVIORAL
Instrumental music listeningVocal music listening
Audiobook listeningBEHAVIORAL
Audiobook listening (control)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Hemispheral stroke

You may not qualify if:

  • Previous neurological or current psychiatric disease,
  • severe aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Valtteri Kaasinen, MD

    Department of Clinical Neurosciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

December 1, 2012

Primary Completion

April 5, 2016

Study Completion

April 5, 2016

Last Updated

January 5, 2022

Record last verified: 2021-12

Locations

FI(1)