UMIN-CTR Clinical Trial

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

Mild Cognitive Impairment

Classification by specialty

Neurology	Psychiatry	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Memory Clinic Ochanomizu

Institute

Department

Personal name

Organization

Citizen Watch Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

メモリークリニックお茶の水

Date of disclosure of the study information

2018

Year

10

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

10

Month

14

Day

Last modified on

2022

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039046