Parkinson DiseaseNCT04212897
fNIRS Studies of Music Intervention of Parkinson's Disease
A study testing Music Therapy in people with Parkinson Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Lanlan Pu, MD, 180 9887 2622, pulanlan_2005@163.com
Zhanhua Liang, MD, 180 9887 7717, zhanhualiang@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Music Therapy
- Keywords
- Parkinson Disease, Music Therapy, fNIRS, Controlled Trials, Explicit & Implicit Timing, Motor Control, Synchronous finger tapping
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | This group will be asked to practice a rhythmic auditory SFT intervention task at home. Receives: Other: Music Therapy |
| No Music Therapy | No intervention | This group will not engage in an intervention task at home and will be asked to continue their normal daily routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Functional Near-infrared Spectroscopy from baseline
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.
Measured: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Change in Synchronous Finger Motor Control Timing Abilities from baseline
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.
Measured: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Change in Continuous Finger Motor Control Timing Abilities from baseline
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.
Measured: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Change in Unified Parkinson Disease Rating Scale (UPDRS) from baseline
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.
Measured: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Secondary outcomes (2)
Montreal Cognitive Assessment (MoCA)
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.
Measured: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
n-Back Working Memory Assessment
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.
Measured: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start18 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalian University of Technology, University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Zhanhua Liang, MD, Principal investigator, The First Affiliated Hospital of Dalian Medical UniversityBingwei Zhang, MD, Principal investigator, The First Affiliated Hospital of Dalian Medical UniversityFengyu Cong, PhD, Principal investigator, Dalian University of TechnologyWilliam C Tang, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212897
- Sponsor's protocol ID
- PJ-KY-2019-123
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2019
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33066811
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Benefits of Music for Parkinson's Disease: a fNIRS Study Protocol for Controlled Trial
- ClinicalTrials.gov ID
- NCT04212897
- Acronym / sponsor ID
- PJ-KY-2019-123
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Music Therapy, fNIRS, Controlled Trials, Explicit & Implicit Timing, Motor Control, Synchronous finger tapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Dalian University of Technology, University of California, Irvine
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music TherapyThis group will be asked to practice a rhythmic auditory SFT intervention task at home. |
| No Music Therapy | No intervention | –This group will not engage in an intervention task at home and will be asked to continue their normal daily routine. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyParticipants 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. | Other | Music Therapy |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 33066811Pu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanhua Liang, MD principal investigator
The First Affiliated Hospital of Dalian Medical University
Bingwei Zhang, MD principal investigator
The First Affiliated Hospital of Dalian Medical University
Fengyu Cong, PhD principal investigator
Dalian University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Parkinson Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lanlan Pu, MD (180 9887 2622, pulanlan_2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Functional Near-infrared Spectroscopy from baseline (time frame: Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.