fNIRS Studies of Music Intervention of Parkinson's Disease

August 20, 2021 updated by: The First Affiliated Hospital of Dalian Medical University

Therapeutic Benefits of Music for Parkinson's Disease: a fNIRS Study Protocol for Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lanlan Pu, MD
        • Principal Investigator:
          • Zhanhua Liang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music Therapy
This group will be asked to practice a rhythmic auditory SFT intervention task at home.
Other: 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.
No Intervention: No Music Therapy
This group will not engage in an intervention task at home and will be asked to continue their normal daily routine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Functional Near-infrared Spectroscopy from baseline
Time Frame: 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.
Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Change in Synchronous Finger Motor Control Timing Abilities from baseline
Time Frame: 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.
Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Change in Continuous Finger Motor Control Timing Abilities from baseline
Time Frame: 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.
Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Change in Unified Parkinson Disease Rating Scale (UPDRS) from baseline
Time Frame: 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.
Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: 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.
Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
n-Back Working Memory Assessment
Time Frame: 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.
Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Dalian Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Irvine
Dalian University of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhanhua Liang, MD, The First Affiliated Hospital of Dalian Medical University
  • Principal Investigator: Bingwei Zhang, MD, The First Affiliated Hospital of Dalian Medical University
  • Principal Investigator: Fengyu Cong, PhD, Dalian University of Technology
  • Principal Investigator: William C Tang, PhD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PJ-KY-2019-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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