Music therapy after stroke: Assessing the impact of motivation and neuroplasticity on recovery of upper-limb impairment and attention deficits.

Conditions: Stroke
Cerebrovascular accident (CVA)
10007963

Registration Number: NL-OMON51898

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Must be 18 years or older
- Subjects in the sub-acute group have experienced a supratentorial stroke (a
first and only stroke) between 2 weeks and up to 6 months before enrollment.
Subjects in the chronic stroke group have experienced a stroke of the middle
cerebral artery (MCA) (a first and only stroke) of the middle cerebral artery
(MCA) between 6 and 36 months at the time of enrollment, and residual
upper-limb impairment, indicated by a more homogenous sample for MRI
comparisons.
- Subjects in the sub-acute phase of stroke will have a referral for a paretic
upper limb, i.e. partial loss of the capacity to carry out a voluntary upper
limb movement and/or difficulty with attention, i.e. they are easily
distractible or unable to focus on a specific task in the presence of competing
information, or complain of decline in attention. Subjects in the chronic phase
of stroke must all have a referral for a paretic upper-limb, with or without
difficulty with attention.
-Subjects must be able to receive music therapy for a minimum of two sessions
per week, for a total of 9 (6 at minimum) sessions over an average of 5 weeks
(minimum two, maximum 8). For the subacute group the frequency of sessions is
based on their ability and expected length of stay.
- Language: Good command of Dutch or English

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

- Upper limb paralysis (total or very severe loss of the ability to move a
muscle or muscle groups of the affected upper extremity), as assessed by the
Medical Research Scale (MRC) for muscle strength.
- Severe behavioural and/or cognitive problems (a score <24 for the chronic
group, or <21 for the subacute group on the Mini-mental state examination;
MMSE) that prevent a participant from understanding instructions or being able
to participate in music therapy sessions, which will be confirmed as necessary
by the treating physician.
- Severe communication problems, e.g., aphasia and/or apraxia of speech, will
be confirmed by the treating physician.
- Psychiatric, substance abuse, or neurological comorbidity that may interfere
with the study measurements.
- Initiating additional new musical activities during the course of the study.

Additionally, participants in the chronic phase who meet the following criteria
will be excluded from the study, to qualify for MRI scanning:
- Participants who have pacemakers, brain stimulators, dental implants or
metallic braces, aneurysm clips (metal clips on the wall of a large artery),
metallic prostheses (including metal pins and rods, heart valves, and cochlear
implants), permanent eyeliner, insulin pumps, or shrapnel fragments, and/or
claustrophobia.
- Inability (or refusal) to remove metal objects on their person.
- Currently (or intending to become) pregnant, or breastfeeding throughout the
study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the within-subject change in motivation due to the<br /><br>NMT in the sub-acute phase, comparing the pre-and post-measures for the<br /><br>intervention period to the pre- and post-measures for the control period. For<br /><br>the chronic phase group, the primary study parameter is motor function-related<br /><br>neural changes after NMT compared to a control period as measured with<br /><br>functional and structural MRI.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters pertain to behavioural increases in upper-limb function,<br /><br>cognition, and self-reported well-being in both groups, and changes in<br /><br>motivation following NMT in the chronic group. Secondary neuroimaging<br /><br>parameters in chronic stroke pertain to white matter changes and resting-state<br /><br>connectivity in areas of music-reward as an indication of motivation,<br /><br>resting-state connectivity and task-based activation related to cognition, and<br /><br>task-based functional connectivity of auditory-motor networks, as well as<br /><br>correlations between motor improvement and neural changes in brain motor<br /><br>regions.</p><br>