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
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
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
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
