NCT06223529

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

October 3, 2023

Last Update Submit

July 30, 2024

Conditions

Keywords

Neurologic Music Therapyelectroencephalography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Electroencephalogram (EEG): Amplitude of P3 event-related potential

    baseline: pre-intervention, immediately after the intervention

  • Electroencephalogram (EEG): Frontal Alpha Asymmetry

    baseline: pre-intervention, immediately after the intervention

  • Action Research Arm Test (ARAT)

    Baseline, pre-intervention (week 4), post-intervention (week 7), follow-up (week 10)

  • Nine hole peg test

    Baseline (week 1), pre-intervention (week 4), post-intervention (week 7), Follow-up (week 10)

Other Outcomes (1)

  • Stroke Specific Quality of Life Questionnaire

    Baseline (week 1), pre-intervention (week 4), post-intervention (week 7), follow-up (week 10)

Study Arms (1)

Music intervention

EXPERIMENTAL

Music-based exercises for arm/hand coordination, range of movement and dexterity using a selection of hand percussion, stand-mounted percussion and tablet with touchscreen instruments.

Behavioral: Therapeutic Instrumental Music Performance

Interventions

Exercises using musical instruments to improve hemiparetic hand and arm function

Music intervention

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18+
  • Ischemic stroke
  • Three weeks to 60 months post-stroke
  • to 49/57 Action Research Arm Test (ARAT) score \*
  • Able to follow instructions and consent
  • Right-hand dominant

You may not qualify if:

  • Hemorrhagic stroke
  • No movement in arm
  • Unable to consent to participate
  • Currently receiving music therapy
  • Left-hand dominant
  • Ambidextrous
  • Not registered with a GP. We will require GP details to inform them in case of any incidental findings in the EEG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridgeshire COmmunity Services NHS Trust

Bedford, Bedfordshire, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19673814BACKGROUND
  • 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/fpsyg.2019.01561. eCollection 2019.

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander J Street, PhD

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander J Street, PhD

CONTACT

Clemens Maidhof, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The person collecting data on quality of life and arm function in participants' homes will be blinded to whether pre- or post intervention
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single case series pre-/post EEG with repeated upper limb measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow (Music therapy)

Study Record Dates

First Submitted

October 3, 2023

First Posted

January 25, 2024

Study Start

July 1, 2024

Primary Completion

February 28, 2025

Study Completion

May 1, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations