UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038834 |
|---|---|
| Receipt number | 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 | 2021/12/10 12:29:23 |
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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
The ECG monitoring was conducted under neck exposure alone. 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. RRI 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 monitored 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.
After the muscle loading exercise, hemoglobin oxygenation index values were measured and analyzed using a functional near-infrared spectroscopy (fNIRS) device (Pocket NIRS Duo, DynaSense, Hamamatsu, Japan).
To conduct muscle loading exercises, the participants in sitting position performed the wrist curl exercise (3 sets of 20 repetition cycles) in their left hand using a 3kg dumbbell.
MF exposure to the left forearm was carried out for 15 min.
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
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Effects of forearm exposure to magnetic field (MF) on ulnar arterial 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 arterial 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 arterial 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 flow-mediated dilation (FMD). The MF or sham exposure was conducted continuously for 30 min.
Interventions/Control_6
Effects of forearm exposure to MF on hemoglobin oxygenation index after muscle loading exercise in forearm. The MF or sham exposure was conducted continuously for 15 min.
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
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
hideyukiokano@aol.com
Sponsor or person
Institute
Saitama University
Institute
Department
Personal name
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
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
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255242
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255242
Number of participants that the trial has enrolled
20
Results
1)Forearm, upper arm, or neck exposure, had significantly increased ulnar arterial blood flow velocity compared to the sham exposures.
2)After muscle loading exercise, MF exposure recovered hemoglobin oxygenation index values faster and higher than sham exposure.
3)MF exposure in the neck region had significantly increased parasympathetic high-frequency activity relative to the sham exposure.
4)The MF exposure in the upper arm region significantly increased the FMD compared to the sham exposure.
Results date posted
| 2021 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 05 | Day |
Baseline Characteristics
The inclusion criteria were as follows:
1) participants have not used any form of physical therapy and have not taken any vasoactive medication during the study period;
2) subjects' body temperature, heart rate (HR), systolic and diastolic blood pressures (BP) were within normal ranges.
Participant flow
First, 18 healthy right-handed adult male volunteer students were recruited by e-mail from Saitama University. We asked them to participate in face-to-face interview. A response was obtained from 14 men, of whom 12 were eligible and then enrolled in protocol A including the measurements of blood flow velocity, blood pressure and heart rate, the functional near infrared spectroscopy (fNIRS) measurement, and the ECG measurement. Two subjects were excluded as they did not meet inclusion criteria. Eventually, recruitment and enrollment of 10 participants in protocol A was conducted from October 2017 to April 2020. Thus, protocol A was completed in 10 participants
Second, 16 healthy right-handed adult male volunteer students were recruited and enrolled in protocol B for FMD measurement alone using the same criteria. Protocol B included 6 participants from protocol A. Recruitment and enrollment in protocol B was conducted from February 2018 to March 2020.
Adverse events
None
Outcome measures
1) Ulnar arterial blood flow velocity
2) Hemoglobin oxygenation index, oxyhemoglobin (oxyHb), deoxyhemoglobin (deoxyHb) and total hemoglobin
3) Electrocardiogram(ECG), RRI, HF, LF/HF
4) Flow-mediated dilation(FMD)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 11 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 11 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 09 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044252
