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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018330
Receipt No. R000021213
Scientific Title The bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Date of disclosure of the study information 2015/07/16
Last modified on 2017/01/16

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Basic information
Public title The bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Acronym The bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Scientific Title The bradycardiac effect and safety of magnetic vagal nerve stimulation in healthy human
Scientific Title:Acronym 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
1st name
Middle name
Last name Ide Tomomi
Organization Kyushu University
Division name Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
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
1st name
Middle name
Last name Saku Keita
Organization Kyushu University
Division name Department of Therapeutic Regulation of Cardiovascular Homeostasis, Center for Disruptive Cardiovasc
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 06 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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