Music Listening and Stroke Recovery (MUKU2)

This study is currently recruiting participants.
Verified June 2013 by Turku University Hospital
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01749709
First received: December 12, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

Clinical study including 60 subjects to investigate the effect of daily music listening on stress parameters during the acute phase of stroke and on recovery. 20 subjects listen to instrumentala music, 20 listen to music with lyrics and 20 are controls. Outcome measures in the acute phase are levels of physiological stress parameters (cortisol, endorphin, oxytocin). Outcome measures in the recovery phase are cognitive capabilities and mood measured with standard clinical tests. Follow-up time is 6 months.


Condition Intervention
Stroke
Behavioral: Music listening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cognitive Stimulation on Recovery After Stroke

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • physiological stress indicator [ Time Frame: Within two weeks after stroke ] [ Designated as safety issue: No ]
    cortisol, beta-endoprhin and oxytocin concentration in salivary samples

  • Neuropsychological performance [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Standard neuropsychological test battery

  • Brain MRI [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Instrumental music listening
Daily music listening
Behavioral: Music listening
Experimental: Vocal music listening
Daily music listening
Behavioral: Music listening
No Intervention: control
Standard rehabilitation

Detailed Description:

Please see above

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Hemispheral stroke

Exclusion Criteria:

  • Previous neurological or current psychiatric disease,
  • severe aphasia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749709

Contacts
Contact: Seppo Soinila, MD seppo.soinila@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland
Contact: Seppo Soinila, Prof.         
Sponsors and Collaborators
Turku University Hospital
Academy of Finland
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01749709     History of Changes
Other Study ID Numbers: 85/180/2011
Study First Received: December 12, 2012
Last Updated: June 24, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
Stroke
Recovery
Music

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014