UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023196 |
|---|---|
| Receipt number | R000026743 |
| Scientific Title | Effects of interferential current stimulation on autonomic activity |
| Date of disclosure of the study information | 2016/07/16 |
| Last modified on | 2018/07/18 09:22:49 |
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Basic information
Public title
Effects of interferential current stimulation on autonomic activity
Acronym
Effects of interferential current stimulation on autonomic activity
Scientific Title
Effects of interferential current stimulation on autonomic activity
Scientific Title:Acronym
Effects of interferential current stimulation on autonomic activity
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of cervical interferential current stimulation on autonomic activity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
respiratory sinus arrhythmia (RSA) amplitude
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
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interferential current stimulation (beat frequency x1 Hz) for 30 min.
Interventions/Control_2
Interferential current stimulation (beat frequency x2 Hz) for 30 min.
Interventions/Control_3
no stimulation.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
Subjects who are currently treated at a medical institution.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Hyogo College of Medicine
Division name
Department of Physiology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
yoku@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nakamura |
Organization
Hyogo College of Medicine
Division name
Divisio of Research Coorperation
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6066
Homepage URL
rinri@hyo-med.ac.jp
Sponsor or person
Institute
Department of PHysiology, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Food Care Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 24 | 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
| 2016 | Year | 07 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026743
