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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01749709
Other study ID # 85/180/2011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2012
Est. completion date April 5, 2016

Study information

Verified date December 2021
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Please see above


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 5, 2016
Est. primary completion date April 5, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Acute Hemispheral stroke Exclusion Criteria: - Previous neurological or current psychiatric disease, - severe aphasia

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Music listening

Audiobook listening


Locations

Country Name City State
Finland Turku University Hospital Turku

Sponsors (2)

Lead Sponsor Collaborator
Turku University Hospital Academy of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in neuropsychological performance (verbal memory) Verbal memory summary score (RBMT story recall, auditory-verbal learning task) From acute to 6-month-stage
Secondary Change in neuropsychological performance (Language skill) Verbal fluency task From acute to 3-month-stage
Secondary Change in neuropsychological performance (Language skill) Naming test CERAD/Boston Naming Test (BNT) From acute to 3-month-stage
Secondary Change in neuropsychological performance (Language skill) Short Token Test From acute to 3-month-stage
Secondary Change in neuropsychological performance (Language skill) Verbal fluency task From acute to 6-month-stages
Secondary Change in neuropsychological performance (Language skill) Naming test CERAD/BNT From acute to 6-month-stages
Secondary Change in neuropsychological performance (Language skill) Short Token Test From acute to 6-month-stages
Secondary Change in mood Profile of Mood States From acute to 3-month-stage
Secondary Change in mood Profile of Mood States From acute to 6-month-stage
Secondary Change in structural gray matter Voxel-based morphometry From acute to 3-month-stage
Secondary Change in structural gray matter changes Voxel-based morphometry From acute to 6-month-stage
Secondary Change in structural white matter Diffusion-weighted imaging From acute to 3-month stage
Secondary Change in structural white matter Diffusion-weighted imaging From acute to 6-month stage
Secondary Change in neuronal function Resting state/task-based fMRI From acute to 3-month stage
Secondary Change in neuronal function Resting state/task-based fMRI From acute to 6-month stage
Secondary Change in physiological stress level Cortisol serum concentration From acute to 3-month-stage
Secondary Change in physiological stress level Cortisol serum concentration From acute to 6-month-stage
Secondary Change in physiological stress level Beta-endorphin serum concentration From acute to 3-month-stage
Secondary Change in physiological stress level Beta-endorphin serum concentration From acute to 6-month-stage
Secondary Change in physiological stress level Oxytocin serum concentration From acute to 3-month-stage
Secondary Change in physiological stress level Oxytocin serum concentration From acute to 6-month-stage
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