Music Listening and Stroke Recovery (MUKU2)
This study is not yet open for participant recruitment.
Verified December 2012 by Turku University Hospital
Sponsor:
Turku University Hospital
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01749709
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
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: | December 13, 2012 |
| 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 May 23, 2013