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临床试验/NCT06215703
NCT06215703已完成不适用

Optimizing Music-based Interventions for Stroke: a Mechanistic Crossover Study of the Effects of Music Improvisation and Live Accompaniment on Motor, Autonomic, and Neural Response During a Music Playing Task Among Survivors of Stroke and Matched Healthy Control Participants

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task

研究概览

简要总结

This study will enroll stroke patients and healthy participants. Participants will complete baseline measures followed by a music playing task during fMRI and simultaneous measurement of motor response using electromyography (EMG) and accelerometry and affective response using electrodermal activity (EDA) and self-reports. The music task consists of tapping an MRI-compatible MIDI drum with either: (1) improvisation or maintaining the beat and (2) live or recorded piano accompaniment. The primary objectives are to identify the motor, affective, and neural outcomes of improvisation and live accompaniment in music playing tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For participants with stroke, to be eligible to participate in this study, an individual must meet all the following criteria:
  • •hemiparesis resulting from a stroke (ischemic or hemorrhagic) at least 6 months before the enrollment into the study
  • •age from 18 to 89 years
  • •ability to move the wrist flexor and extensor muscles without help from the healthy side, scoring above 3 on the Medical Research Council (MRC) Scale for Muscle Strength, reflecting active movement against gravity
  • •no more than mild resistance to passive movement in the wrist extensor muscle - as demonstrated by a score <2 on the Ashworth Scale (Brashear et al.., 2002)
  • •a modified Rankin Scale (mRS) < 3 indicating moderate to mild disability and the ability to ambulate independently (Bonita & Beaglehole, 1988)
  • •ability to comprehend language and provide informed consent
  • •consenting to participate and willingness to complete MRI testing procedures
  • •For neurologically normal control (NC) participants, to be eligible to participate in this study, an individual must meet all the following criteria:
  • •be matched for age, gender, and socioeconomic status (education level) to a previously enrolled participant with stroke
  • •age from 18 to 89 years
  • •no history of neurological injury
  • •ability to comprehend language and provide informed consent
  • •consenting to participate and willingness to complete MRI testing procedures

排除标准

  • •history of neurological injury other than stroke
  • •moderate to severe depression symptoms indicated by a score >10 on the Patient Health Questionnaire - 9 (PHQ-9; Koenke et al., 2001; Williams et al., 2005)
  • •visual impairment unable to be corrected with glasses/contact lenses sufficient to allow reading comprehension
  • •actively performing or practicing a musical instrument more than 2 hours/week
  • •musical anhedonia indicated by a score < 65 on the Barcelona Music Reward Questionnaire (BMRQ; Mas-Herrero et al., 2013)
  • •amusia as measured by the Montreal Battery of the Evaluation of Amusia (MBEA; Peretz et al., 2003)
  • •not being compatible with MRI testing, including having implanted devices, previous exposure to metallic fragments, large tattoos, claustrophobia, and pregnancy

研究组 & 干预措施

Order 1

Experimental

Participants randomized to Order 1 will complete the four music playing tasks in the following order: (1) No improvisation (maintain beat), no live accompaniment (recorded accompaniment); (2) Improvisation, no live accompaniment (recorded accompaniment); (3) No Improvisation (maintain beat), live accompaniment; (4) Improvisation, live accompaniment.

干预措施: Music Playing Task (Behavioral)

Order 2

Experimental

Participants randomized to Order 2 will complete the four music playing tasks in the following order: (1) Improvisation, no live accompaniment (recorded accompaniment); (2) No improvisation (maintain beat), no live accompaniment (recorded accompaniment); (3) Improvisation, live accompaniment; (4) No improvisation (maintain beat), live accompaniment.

干预措施: Music Playing Task (Behavioral)

Order 3

Experimental

Participants randomized to Order 3 will complete the four music playing tasks in the following order: (1) No improvisation (maintain beat), live accompaniment; (2) Improvisation, live accompaniment; (3) No improvisation (maintain beat), no live accompaniment (recorded accompaniment); (4) Improvisation, no live accompaniment (recorded accompaniment).

干预措施: Music Playing Task (Behavioral)

Order 4

Experimental

Participants randomized to Order 3 will complete the four music playing tasks in the following order: (1) Improvisation, live accompaniment; (2) No improvisation (maintain beat), live accompaniment; (3) Improvisation, no live accompaniment (recorded accompaniment); (4) No improvisation (maintain beat), no live accompaniment (recorded accompaniment).

干预措施: Music Playing Task (Behavioral)

结局指标

主要结局

Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

Total Acceleration of Hand Movements during No Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

Neural Activation in Primary Motor Cortex during Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Neural Activation in Supplementary Motor Cortex during Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Total Acceleration of Hand Movements during Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

Total Acceleration of Hand Movements during No Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

Total Muscle Activation during Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

Total Muscle Activation during Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

Total Muscle Activation during No Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

Neural Activation in Primary Motor Cortex during No Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Total Muscle Activation during No Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

Neural Activation in Primary Motor Cortex during Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Neural Activation in Primary Motor Cortex during No Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Neural Activation in Supplementary Motor Cortex during Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Neural Activation in Supplementary Motor Cortex during No Improvisation + No Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Neural Activation in Supplementary Motor Cortex during No Improvisation + Live Accompaniment Task

时间窗: Day 1 (About 3 hours)

Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

次要结局

  • Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Electrodermal Activity (EDA) during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Amygdala during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Functional Connectivity with the Ventral Striatum during Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Functional Connectivity with the Ventral Striatum during Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Functional Connectivity with the Ventral Striatum during No Improvisation + No Live Accompaniment Task(Day 1 (About 3 hours))
  • Functional Connectivity with the Ventral Striatum during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))
  • Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task(Day 1 (About 3 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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