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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038834
Receipt No. R000044252
Scientific Title Effects of a 50 Hz magnetic field on blood flow velocity, ECG and vascular endothelial function in healthy adults
Date of disclosure of the study information 2019/12/12
Last modified on 2020/07/08

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Basic information
Public title Effects of a 50 Hz magnetic field on blood flow velocity, ECG and vascular endothelial function in healthy adults
Acronym Effects of a 50 Hz magnetic field on physiological parameters in healthy adults
Scientific Title Effects of a 50 Hz magnetic field on blood flow velocity, ECG and vascular endothelial function in healthy adults
Scientific Title:Acronym Effects of a 50 Hz magnetic field on physiological parameters in healthy adults
Region
Japan

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

Objectives
Narrative objectives1 In this study, we attempted to clarify the acute physiological effects of a 50 Hz sinusoidal magnetic field exposure at peak magnetic flux density Bmax 180 mT on blood flow velocity and electrocardiogram (ECG) and flow-mediated dilation (FMD) in healthy human subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Measurement of blood flow velocity was conducted under one of three types of regional exposures, i.e., forearm exposure, upper arm exposure and neck exposure to a 50 Hz MF at Bmax 180 mT/Brms 127 mT on the surface of the MF exposure device. The MF or sham exposure was performed continuously for 15 min. In all cases of exposures, an ultrasound probe was positioned on the ventral skin surface of the bared left forearm to assess the blood flow velocity in an ulnar artery. In the case of forearm exposure, after putting on the dorsal side of the left forearm on the MF exposure device for about 5 min, the blood flow velocity (peak systolic velocity [PSV] in pulsed wave [PW] mode) in an ulnar artery was measured noninvasively from the ventral side of the forearm at 5-min intervals for 25 min by using a potable digital color Doppler ultrasound system (JS2 with a linear probe L741, 5-12 MHz, Medicare Co., Ltd., Shenzhen, China).
The forearm was positioned on an MF exposure device for about 30 min to keep the arm motionless as long as possible during the clinical trial in each subject. At each time point, the PSV was measured in triplicate for the blood flow velocity and the mean values was calculated. For upper arm exposure, an additional second MF exposure device was positioned to the dorsal side of the upper arm. For neck exposure, an additional third MF exposure device was positioned laterally to the dorsal side of the neck. In the cases of upper arm and neck exposure experiments, the MF exposure device for forearm exposure was used to keep posture the same as in the case of forearm exposure experiment without turning on the power. Each crossover trial for each participant was performed twice on different days after a washout period of at least two days and the duplicate data were averaged for each individual in each test. Therefore, the mean value of two trials in MF or sham exposure was used for statistical analysis.
Key secondary outcomes They include electrocardiogram (ECG) and flow-mediated dilation (FMD). The ECG monitoring was conducted under neck exposure alone. The ECG monitoring in each subject was carried out on different days with the measurement of blood flow velocity after a washout period of at least two days. ECG was recorded continuously for 25 min using a multi-channel telemetry system (WEB-1000, Nihon Kohden Co., Ltd., Tokyo, Japan). The MF or sham exposure was conducted continuously for 15 min. Each crossover trial for each participant was performed twice on different days after a washout period of at least two days and the duplicate data were averaged for each individual in each test.Cardiac interbeat interval (RRI) of ECG signal was extracted and used in this analysis. A power spectral analysis of RRI by fast Fourier transformation was performed to obtain the low-frequency (LF) and high-frequency (HF) components and the HF component and the LF/HF ratio were analyzed.
FMD is an index of artery endothelium-derived nitric oxide function. The brachial artery FMD measurement was performed using an FMD monitoring device (UNEXEF18G; UNEX Co., Ltd., Nagoya, Japan). Exposure of the dorsal side of the left upper arm was performed with the subject lying on a bed in the supine position. The brachial artery FMD values in the left upper arm was monitored at the baseline (pre-exposure) and post-exposure. After putting on the dorsal side of the left upper arm on an MF exposure device and attaching the cuff around the left forearm, the FMD values were monitered before and immediately after exposures. FMD test was repeated with an interval of 30 min and the MF or sham exposure was conducted continuously for 30 min. Each crossover trial for each participant was performed twice on different days after a washout period of at least two days and the duplicate data was averaged for each individual in each test.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Effects of forearm exposure to magnetic field (MF) on ulnar artery blood flow velocity. The MF or sham exposure is conducted continuously for 15 min.
Interventions/Control_2 Effects of upper arm exposure to MF on ulnar artery blood flow velocity. The MF or sham exposure was conducted continuously for 15 min.
Interventions/Control_3 Effects of neck exposure to MF on ulnar artery blood flow velocity. The MF or sham exposure was conducted continuously for 15 min.
Interventions/Control_4 Effects of neck exposure to MF on ECG. The MF or sham exposure was conducted continuously for 15 min.
Interventions/Control_5 Effects of upper arm exposure to MF on brachial artery(FMD). The MF or sham exposure was conducted continuously for 30 min.
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
90 years-old >
Gender Male
Key inclusion criteria During the study period, subjects are not used any form of physical therapy and were not taking any vasoactive medication. Subjects' body temperature and systolic and diastolic blood pressures were within normal ranges.
Key exclusion criteria Cases other than abobe.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Okano
Organization Saitama University
Division name Advanced Institute of Innovative Technology
Zip code 338-8570
Address 255 Shimo-Okubo, Sakura-ku, Saitama City, Saitama
TEL +81-80-7992-1919
Email hideyukiokano@aol.com

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Okano
Organization Saitama University
Division name Advanced Institute of Innovative Technology
Zip code 338-8570
Address 255 Shimo-Okubo, Sakura-ku, Saitama City, Saitama
TEL +81-80-7992-1919
Homepage URL
Email hideyukiokano@aol.com

Sponsor
Institute Saitama University
Institute
Department

Funding Source
Organization Saitama University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saitama University
Address 255 Shimo-Okubo, Sakura-ku, Saitama City, Saitama
Tel 048-858-3010
Email kshinkou@gr.saitama-u.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
2019 Year 12 Month 12 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 22
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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 07 Day
Date of IRB
2017 Year 10 Month 24 Day
Anticipated trial start date
2017 Year 10 Month 25 Day
Last follow-up date
2020 Year 04 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 09 Day
Last modified on
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044252

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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