fNIRS Studies of Music Intervention of Parkinson's Disease

NCT ID: NCT04212897

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Patients and the outcomes assessor are blinded in this study

Study Groups

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Music Therapy

This group will be asked to practice a rhythmic auditory SFT intervention task at home.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type OTHER

Participants in the intervention arm will be asked to practice a rhythmic auditory synchronous finger tapping intervention task at home for a total of 25 minutes split between two ten-minute sets with a five-minute break between the sets every day for 8-weeks. During training sessions participants must listen to the instrumental of a pre-selected well-known Chinese melody, "Moonlight over the Lotus Pond" by Phoenix Legend, whose melody duration is 259s. This song was selected for its strong beat and familiarity to the participants. Participants must follow the beats of the melody and tap their right index finger simultaneously to the beats. A visual cue will be displayed to indicate the beats, identical to the one in the assessment. The training session will be conducted once daily after patients have taken their medication. Participants' primary caretaker will be asked to monitor and record completion of sessions.

No Music Therapy

This group will not engage in an intervention task at home and will be asked to continue their normal daily routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Therapy

Participants in the intervention arm will be asked to practice a rhythmic auditory synchronous finger tapping intervention task at home for a total of 25 minutes split between two ten-minute sets with a five-minute break between the sets every day for 8-weeks. During training sessions participants must listen to the instrumental of a pre-selected well-known Chinese melody, "Moonlight over the Lotus Pond" by Phoenix Legend, whose melody duration is 259s. This song was selected for its strong beat and familiarity to the participants. Participants must follow the beats of the melody and tap their right index finger simultaneously to the beats. A visual cue will be displayed to indicate the beats, identical to the one in the assessment. The training session will be conducted once daily after patients have taken their medication. Participants' primary caretaker will be asked to monitor and record completion of sessions.

Intervention Type OTHER

Eligibility Criteria

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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.

* 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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dalian University of Technology

UNKNOWN

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhanhua Liang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Bingwei Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Fengyu Cong, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalian University of Technology

William C Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lanlan Pu, MD

Role: CONTACT

180 9887 2622

Zhanhua Liang, MD

Role: CONTACT

180 9887 7717

Facility Contacts

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Lanlan Pu, MD

Role: primary

180 9887 2622

Zhanhua Liang, MD

Role: backup

180 9887 7717

References

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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.

Reference Type DERIVED
PMID: 33066811 (View on PubMed)

Other Identifiers

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PJ-KY-2019-123

Identifier Type: -

Identifier Source: org_study_id

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