UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036676
Receipt number R000038536
Scientific Title A functional MRI study focusing on the association between adenosine triphosphate and empathy
Date of disclosure of the study information 2019/06/01
Last modified on 2023/10/24 09:10:11

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Basic information

Public title

A functional MRI study focusing on the association between adenosine triphosphate and empathy

Acronym

A functional MRI study focusing on the association between adenosine triphosphate and empathy

Scientific Title

A functional MRI study focusing on the association between adenosine triphosphate and empathy

Scientific Title:Acronym

A functional MRI study focusing on the association between adenosine triphosphate and empathy

Region

Japan


Condition

Condition

Depressive symptoms

Classification by specialty

Medicine in general Psychosomatic Internal Medicine Psychiatry
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In recent years, it is becoming apparent that various organs and cells exchanges information dynamically through several neurotransmitters in the body and this phenomenon supports physical and mental health conditions. In this study, we attempt to reveal the effects of medical equipments that improve physical functions on psychological states such as empathy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

After 10-minute physical stimulation using a low frequency therapy device, we ask the participants to conduct psychological tasks that can evaluate empathy and quantitatively evaluate the influence of transient physical stimulations on empathy.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Perform a 10-minute physical stimulation using a low frequency electric therapy equipment.

Interventions/Control_2

Perform a 10-minute sham-physical stimulation using a low frequency electric therapy equipment.

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

18 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Healty people

Key exclusion criteria

Those who fall under the following which are thought to have a large electric influence compared with the intended effect are excluded. 1.people using psychotropic drugs and drugs that affect the mental state 2. people with sensory disorders such as dull warmth 3. pregnant women 4. people with malignant tumors and heart disease 5. people with skin irritation, injury or lesions 6. people who have a febrile disease, acute inflammation, and purulent disease 7. people who have a possibility of blood flow disorder 8. people who suffer from deep thrombophlebitis 9. people who judged that the doctor is inappropriate

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Matsunaga

Organization

Aichi Medical University School of Medicine

Division name

Department of Health and Psychosocial Medicine

Zip code

4801195

Address

1-1 Yazakokarimata, Nagakute, Aichi

TEL

0561-62-3311

Email

matsunag@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Matsunaga

Organization

Aichi Medical University School of Medicine

Division name

Department of Health and Psychosocial Medicine

Zip code

4801195

Address

1-1 Yazakokarimata, Nagakute, Aichi

TEL

0561-62-3311

Homepage URL


Email

matsunag@aichi-med-u.ac.jp


Sponsor or person

Institute

Aichi Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research <KAKENHI>

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

Aichi Medical University

Address

1-1 Yazakokarimata, Nagakute, Aichi

Tel

0561623311

Email

sec2030@mail.aichi-med-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



Other administrative information

Date of disclosure of the study information

2019 Year 06 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

40

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 07 Month 02 Day

Date of IRB

2018 Year 07 Month 02 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2023 Year 03 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

2019 Year 05 Month 08 Day

Last modified on

2023 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name