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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048359
Receipt No. 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 2022/07/13

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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
Email 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
Email y.taruno@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2027 Year 08 Month 31 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
2022 Year 07 Month 13 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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