UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048359 |
|---|---|
| Receipt number | R000052834 |
| Scientific Title | Exploring the usefulness of online music therapy for Parkinson's disease patients with cognitive impairment. |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2023/12/19 16:27:32 |
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Basic information
Public title
Exploring the usefulness of online music therapy for Parkinson's disease patients with cognitive impairment.
Acronym
Exploring the usefulness of online music therapy for Parkinson's disease patients with cognitive impairment.
Scientific Title
Exploring the usefulness of online music therapy for Parkinson's disease patients with cognitive impairment.
Scientific Title:Acronym
Exploring the usefulness of online music therapy for Parkinson's disease patients with cognitive impairment.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the usefulness of online music therapy for Parkinson's disease patients with cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Parkinson's Disease Questionnaire-39
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Online Music Therapy
Interventions/Control_2
Observation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The International Parkinson and Movement Disorder Society: MDS Parkinson's disease (PD) is diagnosed as Parkinson's disease (clinically accurate or clinically almost certain case) according to the clinical diagnostic criteria for Parkinson's disease (PD) (2015).MDS In the Parkinson's disease with mild cognitive impairment (PD-MCI) diagnostic criteria (2012), the patient meets the PD-MCI specific criteria level II.The research subject must be at least 20 years old and an adult, and written consent must be obtained from the research subject. However, if the research subject has difficulty in writing due to his/her medical condition, a signature by a witness is acceptable after obtaining oral consent from the subject.
Key exclusion criteria
Patients who have participated in any form of music therapy within 24 weeks of the start of the study intervention. Patients with severe visual impairments that make it difficult to operate the equipment necessary for online music therapy. Patients with severe hearing loss or deafness that makes it difficult to perform music therapy. Patients who, for other reasons, have difficulty operating the equipment required for online music therapy, or who do not have a caregiver to operate the equipment. Patients who are judged by the principal investigator or sub-investigator to be inappropriate for safe participation in the study due to severe cognitive impairment and associated peripheral symptoms.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kuzuya |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurology
Zip code
606-8397
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3771
akuzuya@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Taruno |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurology
Zip code
606-8397
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3771
Homepage URL
y.taruno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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