Stroke Clinical Trial
Official title:
The Neural Mechanisms of Music Intervention for Chronic Arm Hemiparesis Following Stroke: A Single Case Series EEG Study
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.
Status | Not yet recruiting |
Enrollment | 5 |
Est. completion date | May 1, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Inclusion Criteria: 1. Aged 18+ 2. Ischemic stroke 3. Three weeks to 60 months post-stroke 4. 12 to 49/57 Action Research Arm Test (ARAT) score * 5. Able to follow instructions and consent 6. Right-hand dominant Exclusion Criteria: 1. Hemorrhagic stroke 2. No movement in arm 3. Unable to move thumb and one finger. Loss of sensation and proprioceptive impairment will not lead to exclusion. 4. Unable to consent to participate 5. Currently receiving music therapy 6. Left-hand dominant 7. Ambidextrous 8. Not registered with a GP. We will require GP details to inform them in case of any incidental findings in the EEG. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Anglia Ruskin University | Cambridgeshire Community Services NHS Trust |
Altenmuller E, Marco-Pallares J, Munte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x. — View Citation
Fachner JC, Maidhof C, Grocke D, Nygaard Pedersen I, Trondalen G, Tucek G, Bonde LO. "Telling me not to worry..." Hyperscanning and Neural Dynamics of Emotion Processing During Guided Imagery and Music. Front Psychol. 2019 Jul 25;10:1561. doi: 10.3389/fps — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Stroke Specific Quality of Life Questionnaire | A questionnaire asking stroke survivors to rate the impact of their stroke on various. (score range 49 - 245, with higher score indicating better quality of life)aspects of their daily living | Baseline (week 1), pre-intervention (week 4), post-intervention (week 7), follow-up (week 10) | |
Primary | Electroencephalogram (EEG): Power in EEG Alpha and Beta frequency bands | Power in EEG Alpha and Beta frequency bands (event-related synchronization and de-synchronization) during simple motor tasks | baseline: pre-intervention, immediately after the intervention | |
Secondary | Electroencephalogram (EEG): Amplitude of P3 event-related potential | The Amplitude of the P3 wave of the event-related potential, elicited during a working memory task | baseline: pre-intervention, immediately after the intervention | |
Secondary | Electroencephalogram (EEG): Frontal Alpha Asymmetry | Magnitude of the Frontal Alpha Asymmetry during a resting-state EEG | baseline: pre-intervention, immediately after the intervention | |
Secondary | Action Research Arm Test (ARAT) | A 19-item measure that is divided into: grasp, grip, pinch and gross movement. Maximum score is 57, which would indicate best possible arm and hand function | Baseline, pre-intervention (week 4), post-intervention (week 7), follow-up (week 10) | |
Secondary | Nine hole peg test | Assessment of finger dexterity. Picking up nine pegs from a dish one at a time and placing into nine holes, then removing one by one and placing back in the dish. Maximum time allowed for our study will be two-minutes. A healthy male would complete it approximately 19 seconds. | Baseline (week 1), pre-intervention (week 4), post-intervention (week 7), Follow-up (week 10) |
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