UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Title of the study (Brief title)	The bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	heart rate blood pressure
Key secondary outcomes	Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	magnetic stimulation 5 Hz, 3 min
Interventions/Control_2	magnetic stimulation 20 Hz, 3 min
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Person who are between the ages of 21 and 60 Person without history of atrial fibrillation Person without had implanted cardiac pacemaker Person without taking cardiovascular agent Person who applied for the subject solicitation Subjects who could make self-judgment and were voluntarily giving written informed consent
Key exclusion criteria	Person who are diagnosed with bradycardia (<=50bpm) Person who is suspected to have an autonomic dysfunction Person who is pregnant or lactating Person judged as unsuitable for the study by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Ide Tomomi
Organization	Kyushu University
Division name	Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5360
Email	tomomi_i@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	Saku Keita
Organization	Kyushu University
Division name	Department of Therapeutic Regulation of Cardiovascular Homeostasis, Center for Disruptive Cardiovasc
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5360
Homepage URL
Email	saku@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 16 Day
Last modified on	2017 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021213