UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046765 |
|---|---|
| Receipt number | R000053352 |
| Scientific Title | Neuronal substrates relating to sense of ownership |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/04/24 10:14:54 |
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Basic information
Public title
Neuronal substrates relating to sense of ownership
Acronym
Neuronal activities and sense of ownership
Scientific Title
Neuronal substrates relating to sense of ownership
Scientific Title:Acronym
Neuronal activities and sense of ownership
Region
| Japan |
Condition
Condition
Normal human subjects
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The sense of body ownership (SoO) is a feeling that I am the one who own the body (Gallagher, 2000). It is a fundamental aspect of self-consciousness, but several pathological conditions are known to modify SoO. The purpose of the study is to identify neuronal substrates for SoO. We will further analyze if interventions in the brain activities could modify SoO, by using repetitive transcranial magnetic stimulation (rTMS) and neurofeedback.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratings in a questionnaire about SoO, which is performed before and immediately after interventions.
Key secondary outcomes
EEG recordings before and immediately after interventions.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
EEG recording, questionnaire > rTMS or neurofeedback (one day) > EEG recording, questionnaire
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal human subjects without past history of neurological diseases.
Key exclusion criteria
Person under the age of 20. Person with past history of neurological diseases. In case of using rTMS, person who is suffering from contraindications, which are described below.
*Person who has intracranial metallic or magnetic pieces, or pacemakers and other implantible medical devices.
*Person with history of seizures or epilepsy.
*Person who takes medications, which could lower threshold for seizures (e.g. TCAs, neuroleptic agents).
*Person who is suffering from drug abuse or withdrawal symptoms.
*Person who is pregnant or has serious illness.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Ohki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
ohkiy@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Ohki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
ohkiy@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-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
| 2022 | Year | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053352
