UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effect of mindfulness meditation training tool for Mild Cognitive Impairment prevention
Acronym	Verification of the effect of mindfulness meditation training tool for MCI prevention
Scientific Title	Verification of the effect of mindfulness meditation training tool for Mild Cognitive Impairment prevention
Scientific Title:Acronym	Verification of the effect of mindfulness meditation training tool for MCI prevention
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Neurology Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intervention using a tool to induce a mindfulness state by a meditation method to regulate breathing, we verify effect of emotion conversion and brain function improvement. We focus particularly on whether real time feedback of autonomic nervous conditions results in a significant improvement of autonomic function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	As autonomic nerve evaluation, electrocardiogram CVRR value (Coefficient of Variation of R-R intervals). We examine the effect difference depending on the presence / absence of the feedback function of the tool, as follows; (1) Comparison between self-style meditation and meditation induction by tools. (2) Comparison between self-style meditation before and after the tool intervention period (MCI patient group: 2 weeks, 5 minutes each day in the morning and evening, young healthy group: 4 weeks, 5 minutes once daily).
Key secondary outcomes	TMT (trail making test) as a brain's attention / performance function evaluation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	Intervention period: 2 weeks Intervention amount: 5 minutes each Frequency: twice daily Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: Yes
Interventions/Control_2	Intervention period: 2 weeks Intervention amount: 5 minutes each Frequency: twice daily Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: None
Interventions/Control_3	Intervention period: 4 weeks Intervention amount: 5 minutes each Frequency: once a day Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: Yes
Interventions/Control_4	Intervention period: 4 weeks Intervention amount: 5 minutes each Frequency: once a day Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: None
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) MCI Patient Group: MCI patient (under 85 years old) visits every week to the day care of our clinic. (2) Young healthy subject group: Young healthy individuals (30 to 65 years old) who routinely care for dementia patients visiting our clinic.
Key exclusion criteria	(1) Subjects having arrhythmia (2) Subjects judged as unsuitable for this study by the investigator for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Asada
Organization	Memory Clinic Ochanomizu
Division name	Medical care Division
Zip code	113-0034
Address	4F Ochanomizu Igakukaikan, 1-5-34, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL	03-6801-8718
Email	asada@memory-cl.jp

Public contact
Name of contact person	1st name Mieko Middle name Last name Tanaka
Organization	Brain Functions Lab., Inc.
Division name	Research Division
Zip code	230-0046
Address	1-508 Leading Venture Plaza, 75-1, Ono-cho, Tsurumi-ku, Yokohama JAPAN
TEL	050-3774-6162
Homepage URL
Email	mtanaka@bfl.co.jp

Sponsor
Institute	Memory Clinic Ochanomizu
Institute
Department

Funding Source
Organization	Citizen Watch Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Brain Functions Lab., Inc., Research Ethics Committee
Address	LVP1-508, 75-1, Ono-cho, Tsurumi-ku, Yokohama 230-0046 JAPAN
Tel	050-3774-6162
Email	ethics@bfl.co.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	メモリークリニックお茶の水

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 15 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	42
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	Completed
Date of protocol fixation	2018 Year 10 Month 07 Day
Date of IRB	2018 Year 10 Month 07 Day
Anticipated trial start date	2018 Year 10 Month 08 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 14 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039046