UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018330 |
|---|---|
| Receipt number | 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 13:41:23 |
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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
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
saku@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021213
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
