Therapeutic Benefits of Music for Parkinson's Disease: a fNIRS Study Protocol for Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Functional Near-infrared Spectroscopy from baseline
研究概览
简要总结
Functional near-infrared spectroscopy (fNIRS) will be used to monitor neuronal activities and connectivity to elucidate the correlation between physiological changes within the brain and the benefits of music therapy for patients afflicted with Parkinson's disease (PD). This study will report on the changes in neural activities as a result of music intervention in PD.
详细描述
Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson's Disease. Despite the plethora of publications that have reported the positive effects of music interventions, little is known about how music improves neuronal activity and connectivity in afflicted patients. In this study, the investigators will use functional near-infrared spectroscopy (fNIRS) to measure oxygenated- (HbO2), deoxygenated- hemoglobin (HbR), and total hemoglobin activation in various parts of the cortex. The fNIRS measurement, in conjunction with the Unified Parkinson's Disease Rating Scale (UPDRS), n-back task, and the Montreal Cognitive Assessment (MoCA), will be performed at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study. The 8-week long intervention will include a daily 25-minute synchronous finger tapping (SFT) intervention (two sets of ten-minute sessions with a five-minute break in between sets) with a pre-selected well-known rhythmical song. The total anticipated number of participants is 150 and the participants will be split into two groups: an intervention group and a control group. Data collected from the two PD groups will be compared to baseline performances from healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients and the outcomes assessor are blinded in this study
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-80 years old, both genders, and right handed;
- •Clinical diagnosis of idiopathic PD according to the 2015 Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease;
- •Rated as stage I to II on the Hoehn and Yahr scale;
- •Scores greater than 21 points on the Montreal Cognitive Assessment (MoCA);
- •Maintain a stable dosing of anti-PD or deep-brain stimulation (DBS) treatment throughout the duration of the study;
- •Able to travel to and participate in the data collection process.
排除标准
- •Individuals who do not meet the inclusion criteria;
- •Presence of significant hearing or visual impairments;
- •Extensive previous musical training;
- •A history of any other neurological condition (i.e. Alzheimer's disease, epilepsy, stroke) or psychiatric disorders (i.e. major depression, psychoses).
结局指标
主要结局
Change from Functional Near-infrared Spectroscopy from baseline
时间窗: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
An ETG-4000 fNIRS system will be used to measure hemoglobin (HBO2) levels in the participant as they perform finger motor control timing assessments. A change, specifically a reduction of HBO2 activation, from baseline measurements indicates reduced cortical activation and suggests improved PD-related symptoms.
Change in Synchronous Finger Motor Control Timing Abilities from baseline
时间窗: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Participants will be asked to tap their right index finger on a standard QWERTY keyboard "1" key when a visual cue appears. The response time for tapping the "1" key, in response to seeing the visual cue, will be measured to assess motor-timing control. Accuracy of response will be dependent on minimizing early or delayed taps (measured in milliseconds) in congruence with the determined rhythm. A change in score, particularly greater accuracy in timing, from baseline indicates better or improved motor control performance.
Change in Continuous Finger Motor Control Timing Abilities from baseline
时间窗: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Participants will be asked to tap their right index finger on a standard QWERTY keyboard "1" key when a visual cue appears. The participants will then be asked to maintain the tapping rhythm without the visual cue for 15 seconds. The timing of tapping the "1" key, without the visual cue, will be measured to assess motor-timing control. Accuracy of response will be dependent on minimizing early or delayed taps (measured in milliseconds) in congruence with the determined rhythm. A change in score, particularly greater accuracy in timing, from baseline indicates better or improved motor control performance.
Change in Unified Parkinson Disease Rating Scale (UPDRS) from baseline
时间窗: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
UPDRS objectively assesses the severity of PD based off the disease's burden on the individual and can describe disease progression and treatment response. A total of 42 ratings are split between multiple categories. Examples of categories measured include mental impairments (mood and intelligence), activities in daily living (speech, salivation, level of independence to perform normal tasks such as turning in bed), motor skills (facial, tremor severity in extremities, rigidity) and other complications. Each category has a 0-4 rating determined by the examiner and summed, where a higher score reflects greater disability (maxed at 195 points). A change in the score, i.e. lower score from baseline, indicates beneficial effects of the intervention.
次要结局
- Montreal Cognitive Assessment (MoCA)(Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up))
- n-Back Working Memory Assessment(Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up))