UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051841 |
|---|---|
| Receipt number | R000059155 |
| Scientific Title | A preliminary study of the relationship between motor readiness potentials and interoception |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2025/03/13 15:28:09 |
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Basic information
Public title
A preliminary study of the relationship between the readiness potentials and interoception
Acronym
A preliminary study of the relationship between motor readiness potentials and interoception
Scientific Title
A preliminary study of the relationship between motor readiness potentials and interoception
Scientific Title:Acronym
A preliminary study of the relationship between motor readiness potentials and interoception
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the readiness potentials and interoception in healthy subjects
Basic objectives2
Others
Basic objectives -Others
To provide basic data for future research planning on mental disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The readiness potentials and various aspects of interoception
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who are able to perform the test adequately.
Subjects who are able to provide written informed consent.
Key exclusion criteria
Subjects with a history of mental illness
Subjects taking medications that affect circulation
Subjects with serious physical complications
Subjects whom the principal investigator determines are not appropriate to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Koreki |
Organization
Shimofusa Psychiatric Medical Center
Division name
Department of Psychiatry
Zip code
266-0007
Address
578, Heta-cho, Midori-ku, Chiba-city
TEL
043-291-1221
rohikiakireko.z3@keio.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Sugiyama |
Organization
Shimofusa Psychiatric Medical Center
Division name
General affairs section
Zip code
266-0007
Address
578, Heta-cho, Midori-ku, Chiba-city
TEL
043-291-1221
Homepage URL
itagaki.koichi.fv@mail.hosp.go.jp
Sponsor or person
Institute
Shimofusa Psychiatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Shimofusa Psychiatric Medical Center
Address
578, Heta-cho, Midori-ku, Chiba-city
Tel
432911221
itagaki.koichi.fv@mail.hosp.go.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
| 2023 | Year | 08 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Neuropsychological tasks relevant to interoception and heartbeat evoked potentials will be measured and their relationship to the readiness potentials will be evaluated.
The influence of pulse on the readiness potentials will also be investigated.
Management information
Registered date
| 2023 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059155
