Clinical trial NCT04212897: fNIRS Studies of Music Intervention of Parkinson's Disease
Official title: Therapeutic Benefits of Music for Parkinson's Disease: a fNIRS Study Protocol for Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Music Therapy
fNIRS
Controlled Trials
Explicit & Implicit Timing
Motor Control
Synchronous finger tapping
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Dalian University of Technology
name: University of California, Irvine
First posted: 2019-12-30
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change from Functional Near-infrared Spectroscopy from baseline
timeFrame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
measure: Change in Synchronous Finger Motor Control Timing Abilities from baseline
timeFrame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
measure: Change in Continuous Finger Motor Control Timing Abilities from baseline
timeFrame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
measure: Change in Unified Parkinson Disease Rating Scale (UPDRS) from baseline
timeFrame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
measure: n-Back Working Memory Assessment
timeFrame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Other outcomes:
Locations:
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Zhanhua Liang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Bingwei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalian University of Technology
name: Fengyu Cong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: William C Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pu L, Qureshi NK, Ly J, Zhang B, Cong F, Tang WC, Liang Z. Therapeutic benefits of music-based synchronous finger tapping in Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China. Trials. 2020 Oct 16;21(1):864. doi: 10.1186/s13063-020-04770-9.