fNIRS Studies of Music Intervention of Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Other: Music Therapy
- Registration Number
- NCT04212897
- Lead Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music Therapy Music Therapy This group will be asked to practice a rhythmic auditory SFT intervention task at home.
- Primary Outcome Measures
Name Time Method Change from Functional Near-infrared Spectroscopy from baseline 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Montreal Cognitive Assessment (MoCA) Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up) MoCA assesses for an individual's cognitive abilities including orientation, concentration and attention, executive functions, memory, conceptual thinking, calculations, language, and visuo-constructional skills. The test is administered for 10-minutes as a one-page 30-point test. The point distribution is as follows. A short-term memory recall task with five nouns and delayed recall after five minutes (5 points). A clock drawing task (3 points) and a three-dimensional cube copy (1 point) are used to assess visuospatial abilities. Executive functioning is measured using the Trail Making B task (1 point), a phonemic fluency task (1 point), and a two-item abstraction task (2 points). A three-item confrontation naming task (3 points) as well as repeating two sentences with complex syntax (2 points) are used to measure language. Lastly, time and place orientation (6 points) is assessed. A larger total score (\> or = 26 is normal) indicates healthy or normal cognition.
n-Back Working Memory Assessment Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up) The n-back task examines an individual's working memory and working memory capacity by employing a visuo-spatial continuous performance task. This study will use 3-back tasks that are delivered digitally and started with a digital countdown. The participant is asked to input a keystroke on standard QWERTY keyboard with their right-hand to indicate whether a target visual stimulus presented on the screen was identical to a previously shown stimulus presented 'n' trials ago. The stimulus will be a white square randomized into one of six positions on a black screen. The first cue stimulus will be presented on the screen for 3 s and the individual has 3 s to respond with a '1' keystroke to indicate 'same' or a '2' keystroke to indicate 'different'. A new stimulus will appear after a 1 s inter-stimulus interval. Each task will include responses to two sets of 15 and thus each assessment will last approximately 10 minutes.
Trial Locations
- Locations (1)
First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China