UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046231 |
|---|---|
| Receipt number | R000052761 |
| Scientific Title | Lateralized effects of transcranial magnetic stimulation on temporal lobe over autonomic functions |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2025/06/16 17:23:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Transcranial magnetic stimulation effects on heart rate variability
Acronym
Lateralized effects of transcranial magnetic stimulation on temporal lobe over autonomic functions
Scientific Title
Lateralized effects of transcranial magnetic stimulation on temporal lobe over autonomic functions
Scientific Title:Acronym
Transcranial magnetic stimulation effects on heart rate variability
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Low frequency repetitive transcranial magnetic stimulation over temporal lobe could affect heart rate variability since temporal lobe and autonomic center such as insula are close and functionally connected. However, those effects are not investigated for now. Threfore rTMS effects over tempora lobes are investigated regarding heart rate variability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hear rate or heart rate variability during or after rTMS compared with before rTMS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Left hemispheric stimulation
Interventions/Control_2
Right hemispheric stimulation
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who can express informed consent by documents.
Key exclusion criteria
No history of neurological or psychiatric disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
Interanational University of Health and Welfare
Division name
School of Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
ogata_k@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
School of Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
Homepage URL
ogata_k@iuhw.ac.jp
Sponsor or person
Institute
School of Pharmaceutical Sciences at Fukuoka, International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Kyushu, International University of Health and Welfare
Address
Enokizu 137-1, Okawa, Fukuoka
Tel
0944-89-2000
q-rinri@iuhw.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
| 2021 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
There was increase of heart rate during right temporal region.
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 04 | 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
| 2021 | Year | 11 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052761
