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Trial record 1 of 1 for:    NCT04212897
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fNIRS Studies of Music Intervention of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04212897
Recruitment Status : Not yet recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Collaborators:
Dalian University of Technology
University of California, Irvine
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Music Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patients and the outcomes assessor are blinded in this study
Primary Purpose: Treatment
Official Title: Therapeutic Benefits of Music for Parkinson's Disease: a fNIRS Study Protocol for Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04212897


Contacts
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Contact: Lanlan Pu, MD 180 9887 2622 pulanlan_2005@163.com
Contact: Zhanhua Liang, MD 180 9887 7717 zhanhualiang@163.com

Locations
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China, Liaoning
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Contact: Lanlan Pu, MD    180 9887 2622    pulanlan_2005@163.com   
Contact: Zhanhua Liang, MD    180 9887 7717    zhanhualiang@163.com   
Sub-Investigator: Lanlan Pu, MD         
Principal Investigator: Zhanhua Liang, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Dalian University of Technology
University of California, Irvine
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT04212897    
Other Study ID Numbers: PJ-KY-2019-123
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Dalian Medical University:
Parkinson Disease
Music Therapy
fNIRS
Controlled Trials
Explicit & Implicit Timing
Motor Control
Synchronous finger tapping
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases