UMIN-CTR Clinical Trial

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
Email	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
Email	ogata_k@iuhw.ac.jp

Sponsor
Institute	School of Pharmaceutical Sciences at Fukuoka, International University of Health and Welfare
Institute
Department

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
Email	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
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	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	2024 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	2021 Year 11 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052761

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.