The primary objectives of the study are to investigate the underlying mechanisms of music therapy for stroke patients experiencing upper-limb impairments and/or cognitive deficits, by assessing the effects of NMT on motivation in the sub-acute phase…
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Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the within-subject change in motivation due to the
NMT in the sub-acute phase, comparing the pre-and post-measures for the
intervention period to the pre- and post-measures for the control period. For
the chronic phase group, the primary study parameter is motor function-related
neural changes after NMT compared to a control period as measured with
functional and structural MRI.
Secondary outcome
Secondary parameters pertain to behavioural increases in upper-limb function,
cognition, and self-reported well-being in both groups, and changes in
motivation following NMT in the chronic group. Secondary neuroimaging
parameters in chronic stroke pertain to white matter changes and resting-state
connectivity in areas of music-reward as an indication of motivation,
resting-state connectivity and task-based activation related to cognition, and
task-based functional connectivity of auditory-motor networks, as well as
correlations between motor improvement and neural changes in brain motor
regions.
Background summary
Stroke is a highly disabling condition, for which music therapy is regularly
used in rehabilitation. Proposed possible mechanisms of the effects of music
therapy focus on 1) motivational aspects of music, as well as 2) increased
neuroplasticity due to multisensory stimulation. In this study, changes in
motivation related to Neurologic Music Therapy (NMT) in rehabilitation after
stroke will be investigated in the sub-acute and chronic phases after stroke
and neural correlates of motor improvements after NMT will be investigated for
the chronic phase patients. The outcomes will have implications for the
understanding of the underlying mechanisms of music therapy in stroke recovery,
more specifically regarding the relevance of motivational states and
neuroplasticity in neurorehabilitation.
Study objective
The primary objectives of the study are to investigate the underlying
mechanisms of music therapy for stroke patients experiencing upper-limb
impairments and/or cognitive deficits, by assessing the effects of NMT on
motivation in the sub-acute phase, and neural changes (using MRI) associated
with motor function after NMT in the chronic phase of stroke.
Secondary objectives of the study are to assess NMT-related changes in
motivation in the chronic phase as well as the effects of NMT on behavioral
measures of motor function, cognitive outcomes, and self reported measures of
well-being. Secondary objectives pertaining to neuroimaging in the chronic
phase examine white matter changes related to motivation, resting state
connectivity associated with motivation and cognitive functions, task-based
activation related to dual cognitive-motor tasks, and task-based functional
connectivity of auditory-motor networks, as well as correlating motor
improvement to structural and functional changes of neural motor regions.
As exploratory objectives, we aim to relate motivational changes to outcomes of
wellbeing (quality of life, and mood indices), assess whether engaging in NMT
increases adherence to other therapies in the sub-acute phase, and examine
changes in dual-task interference in the chronic phase.
Study design
The study uses a longitudinal design, with within-subject comparisons in which
participants serve as their own control, which is preferable over a
between-subjects comparison to account for substantial individual differences
expected in stroke patients. All patients will be assessed three times. Those
in the sub-acute phase of stroke will receive baseline measures (TP1) and will
be randomized in a cross-over design to receiving either NMT or standard care
first then a second measurement between conditions (TP2), followed by the other
treatment and a final measurement after both conditions have been administered
(TP3). This design allows to counteract order effects, as well as time effects
due to spontaneous recovery and the non-linear trajectory of recovery in the
sub-acute phase of stroke. Patients in the chronic phase, in whom spontaneous
recovery typically has reached a plateau, a 5-week interval between TP1
(baseline) and TP2 will serve as a control period for changes during the NMT
intervention in the 5 weeks between TP2 and TP3.
Intervention
Participants will receive Neurologic Music Therapy, in particular the following
protocolised methods: Therapeutic Instrument Music Performance (TIMP) and Music
Attention Control Training (MACT) targeting motor and attention functions
respectively, which will be administered in combination during the
intervention. Patients will undergo a target number of 9 sessions, lasting 30
minutes each, over approximately 5 weeks, and adjusted according to their
length of stay in the subacute stage group.
Study burden and risks
Music therapy in general, and NMT specifically, is commonly used with stroke
patients. The risk of NMT is negligible for the participants, however, it may
involve some burden as NMT requires attending 2-3 sessions per week over an
average of 5 weeks. For the subacute group, this will be tailored to their
possibilities and projected length of stay. The risk of motor and
neurocognitive assessments is minimal, as these are mostly pen-and-paper tasks
or involve puzzles, adjusted to this population. For the chronic-phase
patients, the process of obtaining an MRI is non-invasive, participants will be
screened for contraindications including among others claustrophobia, metals on
their person, pregnancy, and medical history. Each MRI session takes
approximately 45 minutes inside the scanner, this also involves some burden of
commuting to the research location, time investment, and limited movement in a
confined space for the duration of the session. Participants are asked to
complete this process three times, which is as few as necessary to answer the
research questions posed in this study. As a between subjects study design will
greatly increase the number of participants and scanning sessions needed, a
within-subjects study design is chosen now in which participants serve as their
own control to minimize overall burden of study participation. Stroke patients
are crucial to answer the study questions, as these findings cannot be
extrapolated from healthy participants due to altered potential for
neuroplasticity during recovery at different stages after stroke.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL78853.058.22 |