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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046529
Receipt No. R000053049
Scientific Title Mindfulness meditation for impulsive-compulsive behaviors in Parkinson's disease: a randomized-controlled study
Date of disclosure of the study information 2022/01/10
Last modified on 2022/01/04

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Basic information
Public title Mindfulness meditation for impulsive-compulsive behaviors in Parkinson's disease: a randomized-controlled study
Acronym MEDIC-PD
Scientific Title Mindfulness meditation for impulsive-compulsive behaviors in Parkinson's disease: a randomized-controlled study
Scientific Title:Acronym MEDIC-PD
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the effect of mindfulness meditation on the impulsive-compulsive behaviors (ICBs) of patients with PD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes The change of Questionnaire for Impulsive-Compulsive Disorders in PD- rating scale (QUIP-RS) score between before and after allocation.
Key secondary outcomes 1. Changes in prevalence of ICBs before and after allocation.
2. The change of following scores between before and after allocation;
(1) Barratt Impulsiveness Scale 11th (BIS-11)
(2) Hospital Anxiety and Depression Scale (HADS)
(3) The MDS-sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
(4) Mindful Attention Awareness Scale (MAAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 mindfulness meditation program
Interventions/Control_2 best medical treatment
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
85 years-old >=
Gender Male and Female
Key inclusion criteria (1) participants diagnosed as clinically established or probable PD according to the diagnostic criteria of Movement Disorder Society, (2) QUIP-RS score was 6 or more, (3) 20 to 85 years old, (4) patients with stable dose of anti-Parkinsonian drugs and (5) who can give written informed consent.
Key exclusion criteria Exclusion criteria are participants who are currently conducting the mindfulness meditation, any other cognitive-behavioral therapy, or any other clinical trials; who have cognitive impairment (lower than 24/30 in Mini-mental state examination); and who cannot carry out the meditation program because of hearing or visual impairment.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Jinsoo
Middle name
Last name Koh
Organization Wakayama Medical University
Division name Department of Neurology
Zip code 641-8510
Address 811-1, Kimiidera, Wakayama-shi, Wakayama
TEL 073-441-0655
Email jinsoo@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Jinsoo
Middle name
Last name Koh
Organization Wakayama Medical University
Division name Department of Neurology
Zip code 641-8510
Address 811-1, Kimiidera, Wakayama-shi, Wakayama
TEL 073-441-0655
Homepage URL
Email shinnai@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address 811-1, Kimiidera, Wakayama-shi, Wakayama
Tel 073-447-2300
Email wa-rinri@wakayama-med.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 10 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
2021 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 10 Day
Last follow-up date
2026 Year 12 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 01 Month 04 Day
Last modified on
2022 Year 01 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053049

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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