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Study protocol
Zhanhua Liang
First Affiliated Hospital of Dalian Medical University
Corresponding Author
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Background: Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson’s disease, Alzheimer’s Disease, and Major Depression. 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.
Methods: For patients suffering from Parkinson’s disease (PD), we propose a daily 25-minute music-based synchronous finger tapping (SFT) intervention for 8-weeks. Eligible participants with PD are split into two groups: an intervention group and a control arm. In addition, a third cohort of healthy controls will be recruited. Assessment of finger tapping performances, the Unified Parkinson’s Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated- (HbO2), deoxygenated- hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study. Data collected from the two PD groups are compared to baseline performances from healthy controls.
Discussion: This exploratory prospective trial study investigates the cortical neuronal activity and therapeutic effects associated with an auditory external cue used to induce automatic and implicit synchronous finger tapping in patients diagnosed with PD. The extent to which the intervention is effective may be dependent on the severity of the disease. The study’s findings are used to inform larger clinical studies for optimization and further exploration of the therapeutic effects of movement-based music therapy on neural activity in neurological diseases.
Trial Registration: The participant recruitment and study protocol have received ethical approval from the First Affiliated Hospital of Dalian Medical University. The hospital Protocol Record number is PJ-KY-2019-123. The protocol was also registered with ClinicalTrials.gov on December 30, 2019 with the Identifier of NCT04212897 and named “fNIRS Studies of Music Intervention of Parkinson's Disease.” The current protocol is version 1.1, revised on September 1, 2020.
The URL of the trial registry record is:
https://clinicaltrials.gov/ct2/show/NCT04212897?term=NCT04212897&draw=2&rank=1
Keywords
Music Therapy, Parkinson’s Disease, fNIRS, Randomized controlled trials, Explicit and Implicit timing, Motor-control, Synchronous finger tapping
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CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 14 Sep, 2020
No community comments so far
Editorial decision: Accept
On 24 Sep, 2020
Review #2 received
Received 20 Sep, 2020
Reviewer #2 agreed
On 17 Sep, 2020
Reviewer #1 agreed
On 14 Sep, 2020
Review #1 received
Received 14 Sep, 2020
Reviewers invited
Invitations sent on 13 Sep, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 09 Sep, 2020
No comments provided
Review #2 received
Received 05 Aug, 2020
Editorial decision: Major revision
On 05 Aug, 2020
Reviewer #2 agreed
On 21 Jul, 2020
Review #1 received
Received 04 May, 2020
Reviewer #1 agreed
On 01 May, 2020
Reviewers invited
Invitations sent on 28 Apr, 2020
Editor assigned
On 26 Mar, 2020
Submission checks complete
On 24 Mar, 2020
First submitted
On 25 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Zhanhua Liang
First Affiliated Hospital of Dalian Medical University
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 14 Sep, 2020
No community comments so far
Editorial decision: Accept
On 24 Sep, 2020
Review #2 received
Received 20 Sep, 2020
Reviewer #2 agreed
On 17 Sep, 2020
Reviewer #1 agreed
On 14 Sep, 2020
Review #1 received
Received 14 Sep, 2020
Reviewers invited
Invitations sent on 13 Sep, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 09 Sep, 2020
No comments provided
Review #2 received
Received 05 Aug, 2020
Editorial decision: Major revision
On 05 Aug, 2020
Reviewer #2 agreed
On 21 Jul, 2020
Review #1 received
Received 04 May, 2020
Reviewer #1 agreed
On 01 May, 2020
Reviewers invited
Invitations sent on 28 Apr, 2020
Editor assigned
On 26 Mar, 2020
Submission checks complete
On 24 Mar, 2020
First submitted
On 25 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson’s disease, Alzheimer’s Disease, and Major Depression. 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.
Methods: For patients suffering from Parkinson’s disease (PD), we propose a daily 25-minute music-based synchronous finger tapping (SFT) intervention for 8-weeks. Eligible participants with PD are split into two groups: an intervention group and a control arm. In addition, a third cohort of healthy controls will be recruited. Assessment of finger tapping performances, the Unified Parkinson’s Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated- (HbO2), deoxygenated- hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study. Data collected from the two PD groups are compared to baseline performances from healthy controls.
Discussion: This exploratory prospective trial study investigates the cortical neuronal activity and therapeutic effects associated with an auditory external cue used to induce automatic and implicit synchronous finger tapping in patients diagnosed with PD. The extent to which the intervention is effective may be dependent on the severity of the disease. The study’s findings are used to inform larger clinical studies for optimization and further exploration of the therapeutic effects of movement-based music therapy on neural activity in neurological diseases.
Trial Registration: The participant recruitment and study protocol have received ethical approval from the First Affiliated Hospital of Dalian Medical University. The hospital Protocol Record number is PJ-KY-2019-123. The protocol was also registered with ClinicalTrials.gov on December 30, 2019 with the Identifier of NCT04212897 and named “fNIRS Studies of Music Intervention of Parkinson's Disease.” The current protocol is version 1.1, revised on September 1, 2020.
The URL of the trial registry record is:
https://clinicaltrials.gov/ct2/show/NCT04212897?term=NCT04212897&draw=2&rank=1
Figure 1
Figure 2
Figure 3
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