Stroke
Conditions
Interventions
Participants in the subacute phase will receive Neurologic Music Therapy, in particular the following protocolised methods: Therapeutic Instrument Music Performance (TIMP) and Music Attention Control
Sponsors
Universiteit Leiden
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
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 had their first-ever supratentorial stroke between 2 weeks and up to 6 months before enrollment. Subjects in the chronic stroke group had a stroke of the middle cerebral artery (MCA) between 6 and 36 months at least 6 before time of enrolment, and present with residual upper-limb impairment or cognitive complaints. - 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 will have mild to moderate impairments in upper-limb function, or difficulty with attention or other cognitive functions, as described above. - Subjects must be able to receive music therapy for a minimum of two sessions per week, over a minimum of two, but ideally between 3-5 weeks. For the subacute group the frequency of sessions is based on their ability and expected length of stay, and for the chronic group the exact division over the week will be determined individually, while adding up to the same total. - Language: Good command of Dutch or English.
Exclusion criteria
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 on the Mini-mental state examination; MMSE) that prevent a participant from understanding instructions or being able to participate in music therapy sessions. For MMSE scores >20, participants in the subacute stroke group will not be excluded, but a follow-up check will be performed to see if dementia has been diagnosed during their stay. In this way, we take into account any disorientation related to the very early phase after a stroke which may not indicate a risk of dementia. - Severe communication problems, e.g., aphasia and/or apraxia of speech. - Psychiatric, substance abuse, or neurological comorbidity that may interfere with the study measurements. - Initiating new musical activities during the course of the study. Additionally, the following exclusion criteria apply to participants in the chronic phase: - 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 [77]. - Inability (or refusal) to remove metal objects on their person. - Currently (or intending to become) pregnant, or breastfeeding throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 DMT compared to a control period as measured with functional and structural MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters pertain to behavioural increases in upper-limb function, cognition, and self-reported well-being in both groups, and changes in motivation following DMT 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. | — |
Countries
Netherlands
Contacts
Public ContactRS Schaefer
Universiteit Leiden
Outcome results
None listed