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The aims of the study are to recruit five participants with stroke upper limb hemiparesis and determine the effects on neural reorganisation of a three-week music intervention using electroencephalogram measures.
Secondly, the researchers will measure for changes in arm function before and after the three-week music intervention.
This is a single-arm pre-/post experiment
Primary research questions:
What are the neuroplastic changes induced by Therapeutic Instrumental Music Performance (TIMP)?
Secondary research questions What are the functional changes in hemiparetic arm and hand induced by TIMP?
Participants will be recruited once they have completed their statutory community stroke rehabilitation.
They will receive 15 X music therapy sessions in their home over three-weeks. Exercises will be delivered by trained clinicians, including music therapists and stroke rehabilitations specialists.
Exercises will be facilitated for full range of arm movement, using a range of percussion instruments on stands and handheld, and iPad with touchscreen instruments, which include keyboards and string instruments that can be played using pinch-grip, holding a stylus/plectrum.
Pre-/post intervention period EEG recordings will made. Stroke Specific Quality of Life (SSQoL), Action Research Arm Test and nine-hole-peg-test data will be collected from participants in their homes at weeks: 1, 4, 7 and 10.
Full description
Recruitment A treating clinician from collaborating healthcare Trust will inform the patients about the study and ask if they are interested. If so, they will provide them with the participant information sheet and ask if the chief investigator (CI) can contact them. Following this, the CI will contact the patient and manage consent.
Once recruited, an assessor will visit the participants in their home to conduct the Action Research Arm Test (ARAT) and nine-hole-peg-test (9HPT) and Stroke Specific Quality of Life Questionnaire (SSQoL) baseline assessment.
After the baseline assessment, the CI will contact the participants to schedule pre-intervention assessments and the 15 sessions over three-weeks. The CI will schedule all assessment and EEG lab visits with participants and Dr Maidhof.
Music Intervention Equipment for music intervention delivery will be brought to the participants' homes and will comprise: Untuned percussion, iPad, guitar.
The iPad and percussion will facilitate every type of hand, finger and arm movement and all movement sequences required to perform activities of daily living. Exercises will progress to facilitate greater range and frequency of movement and complexity (number of instruments or screen targets hit in a sequence) without compromising quality (i.e. avoiding the introduction of compensatory movements).
Music intervention training and supervision The PI will train the music therapist in the music intervention protocol and instruct on how to assess participants in the first session in order to establish the starting exercise - he will provide supervision throughout the treatment period.
Treatment fidelity The participants will be given a questionnaire prior to the first baseline data collection, to record any other interventions, for example pharmacological, that they may be using or due to use. The participants will also be asked to keep a log of activities during each phase of the study. This is to ensure that any changes that occur can be analysed in relation to other activities and interventions, and treatment related changes can be more robustly examined. The music therapist delivering the intervention will keep a log of the content of each session, noting which exercises were completed, duration, breaks and any modification of exercises such as tempo adjustment, spatial arrangement of equipment.
EEG data collection
EEG will be measured on a day before the intervention starts and after it has stopped. Upon arrival, the participants will be asked to fill out a brief questionnaire about handedness, caffeine consumption during the last 24 hours, and other diagnosis relevant for the EEG recording. After the participant's head size is measured, the EEG cap (R-net, Brainproducts, Germany, GmbH) will be prepared and fitted, which will take about 5-15 minutes. After ensuring good signal quality, the different parts of the study will be explained to the participant. These consist of:
Primary data analysis EEG data analysis As this is a single-case series, only descriptive statistics and data visualisation (e.g. bar charts and boxplots) will be used to describe pre- and post-treatment changes in arm function and EEG measures.
With regards to EEG measures, the mean frontal alpha asymmetry (FAA) and its standard deviation will be computed following published guidelines. After a current source density transformation will have been applied, artefact-free 1s epochs of EEG data will be Hanning-windowed and subjected to a Fast Fourier Transformation. Alpha power for each epoch will be calculated as the band (8-13 Hz) value sum and the alpha asymmetry scores will be computed by taking the differences between the natural-log transformed power values of frontal electrodes F4 and F3. The averaged FAA and its standard deviation of the baseline recording will be descriptively compared to the post-treatment recording (visually and in percentage relative change).
Analysis of sensorimotor cortical activity during the self-paced finger and hand tapping tasks, as indexed by event-related oscillatory power in alpha (8-12 Hz) and beta (18-22 Hz) frequency bands, as well as coherence between brain areas, will follow the procedures as described in published research. Artefact-free band-pass filtered (and squared) data in the alpha and beta frequency bands will be segmented into 4s epochs with 2s before and 2s after each tap, with a baseline ranging from 1.5s to 1s before the tap. Three spatial clusters will be used to increase the signal-to-noise ratio: central (electrodes Fz, Fcz, and Cz), ipsilesional, and contralesional. In case of right-sided motor deficits, the ipsilesional cluster would include electrodes C3, F3, and Fc3, and the contralesional cluster would include electrodes C4, F4, and Fc4 (vice versa for left-sided motor deficits). Mean alpha- and beta power during the tapping tasks pre- and post-intervention and standard deviations will be plotted and any changes in mean power will be calculated as percentage relative change.
The P300 component of the event-related potential will be analysed according to established routines in the literature. After artifact cleaning based on independent component analysis and bandpass filtering (0.1-25 Hz), data will be segmented into 1s epochs with a baseline ranging from 200ms to 0ms before stimulus onset. Artifact-free trials of target and non-target stimuli with correct behavioural responses will be baseline corrected and averaged. To assess any pre-post differences, averaged ERPs will be plotted. In addition, pre-post differences in mean amplitude of the P300 component, measured at electrode Pz in a time window of ca. 300ms (centered around the peak amplitude), will be expressed in percentage relative change.
Secondary Data Analysis Action Research Arm Test data will be presented in a box plot, showing scores in the categories of Grasp, Grip, Pinch, Gross at the four data collection timepoints. Pre-/post-intervention period scores in each category will be shown in a graph. Means of measurements pre-intervention, post-intervention will be compared to measurements of data from baseline. Deviations from baseline will be tested by t-tests.
Ethical and regulatory considerations Assessment and management of risk
Below is a list of identified ethical risks and how they will be managed during the study:
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5 participants in 1 patient group
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Central trial contact
Alexander J Street, PhD; Clemens Maidhof, PhD
Data sourced from clinicaltrials.gov
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