UMIN-CTR Clinical Trial

Basic information
Public title	The preventive effect of acupuncture stimulation on optokinetic motion sickness: Examination of optimal acupuncture stimulation conditions in a randomized controlled trial
Acronym	The preventive effect of acupuncture stimulation on optokinetic motion sickness
Scientific Title	The preventive effect of acupuncture stimulation on optokinetic motion sickness: Examination of optimal acupuncture stimulation conditions in a randomized controlled trial
Scientific Title:Acronym	The preventive effect of acupuncture stimulation on optokinetic motion sickness
Region	Japan

Condition
Condition	Optokinetic motion sickness Nausea
Classification by specialty	Medicine in general Gastroenterology Neurology Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study are to investigate the effect of acupuncture stimulation on optokinetic motion sickness had been induced by virtual reality (VR) system in healthy volunteers. We consider the preventive effect of acupuncture stimulation and optimal acupuncture stimulation conditions for various autonomic nervous symptoms such as nausea in a randomized controlled trial using sham needle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The electrogastrogram (EGG) is measured using a portable EGG recorder (EGS2. Nipro Co., Japan). A disposable Ag-AgCl electrodes (Vitrode F, NIHON KODEN, Japan) are placed just under the left and right costal margin at the upper quarter level between the processus xiphoideus and the umbilicus. Moreover, the keratin is removed using tape to reduce the electrical resistance of the skin in before applying the electrodes. EGG data are transferred to a PC at a sampling rate of 1 Hz, then using a fast Fourie's transform (FFT), we compute an algorithm of a power spectra of every 256 sec. Each EGG recording divided into blocks of 60 sec without overlapping. On the power spectrum of each 60 sec, the dominant frequencies of EGG are defined under 0-9 cpm. The percentages of the normogastria range (2-4 cpm), the bradygastria range (0-2 cpm), and the tachygastria range (4-9 cpm) are calculated, respectively. EGG is measured for 20 minutes of 5 minutes at rest before acupuncture stimulation and 15 minutes during VR intervention.
Key secondary outcomes	For the electrocardiogram (ECG), a disposable Ag-AgCl electrodes (Vitrode Bs, NIHON KODEN, Japan) are attached to the chest and amplified using a bio-amplifier (ML132, AD instruments, Australia). The filter settings are high cut filter 60 Hz and the time constant is 0.03 sec. The ECG is taken into a PC at a sampling rate of 1 kHz via an A / D converter (Power Lab 8sp, AD Instruments, Australia), and HRV analysis is used the analysis software Chart5 (AD Instruments, Australia) and HRV module. In the power spectrum obtained by FFT, 0.05-0.15 Hz power is defined as the low-frequency (LF) component, and 0.15-0.4 Hz power is defined as the high-frequency (HF) component. The ratios of LF and HF to the total power values are defined as normalized units of LF (LFnu) and normalized units of HF (HFnu). Moreover, LF / HF is calculated which is the ratio of the LF component and the HF component. The HFnu is used as the index for vagal activity and the LFnu is used as the index of sympathetic activity and the LF/HF ratio is used as the index of sympatho-vagal balance. The measurement is performed for a total of 20 minutes of 5 minutes before acupuncture stimulation and 15 minutes during VR intervention. The evaluation of nausea is performed with 0 points for no symptoms and 100 points for vomiting, and listen to 3 times of before acupuncture stimulation and before/after VR intervention. The subjective symptom of motion sickness (SSMS) is used to evaluate motion sickness. SSMS consists of 7 items of dizziness, headaches, warmth, sweating, drowsiness, increasing salivation, and nausea in motion sickness. The degree of each symptom is rated on a scale of 4 and 6, and the minimum score is 0 and the maximum score is 49. This SSMS is listened to every 3 minutes for 15 minutes corresponding to VR intervention, and the transition of symptoms over time is confirmed.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Control group (sham acupuncture group): After 20 minutes of rest, including placement of the electrodes and the VR head set, the subjects are asked to sit on the chair for a total of 40 min: 5 min baseline period, 20 min acupuncture stimulation, and 15 min VR intervention. The VR intervention is created based on previous reports, and a cylindrical shape with a diameter of 75 cm become a virtual space. A cylindrical shape have alternating white 6.2 cm and black 3.8 cm vertical stripes inside, that is rotated clockwise at a speed of 60 degree per second for 15 minutes to induce optokinetic motion sickness. At this time, the subjects complain of autonomic nervous symptoms and are instructed to remove the VR head set if they could not tolerate it. In sham acupuncture group, we use custom-made (in-house) sham acupuncture needles with disinfected stainless acupuncture needles (0.80 mm diameter and 40 mm length; TAIHO Medical Products Co., Ltd., Hiroshima, Japan) inserted into a custom-made guide tube. The needling sites are performed on ST36 bilaterally located in the tibialis anterior muscle between the head of fibula and the lower end of the tibial tuberosity.
Interventions/Control_2	Manual acupuncture group: After 20 minutes of rest, including placement of the electrodes and the VR head set, the subjects are asked to sit on the chair for a total of 40 min: 5 min baseline period, 20 min acupuncture stimulation, and 15 min VR intervention. The VR intervention is created based on previous reports, and a cylindrical shape with a diameter of 75 cm become a virtual space. A cylindrical shape have alternating white 6.2 cm and black 3.8 cm vertical stripes inside, that is rotated clockwise at a speed of 60 degree per second for 15 minutes to induce optokinetic motion sickness. At this time, the subjects complain of autonomic nervous symptoms and are instructed to remove the VR head set if they could not tolerate it. In manual acupuncture group, we use a sterile stainless acupuncture needle (diameter, 0.20 mm; length, 40 mm; SEIRIN Co., Shizuoka, Japan) and is inserted perpendicularly to a depth of 15~20 mm under the skin, and the manual acupuncture (insert a needle into the body and remain it for a while) is performed for 20 minutes in before VR intervention. The needling sites are performed on ST36 bilaterally located in the tibialis anterior muscle between the head of fibula and the lower end of the tibial tuberosity.
Interventions/Control_3	Electroacupuncture group: After 20 minutes of rest, including placement of the electrodes and the VR head set, the subjects are asked to sit on the chair for a total of 40 min: 5 min baseline period, 20 min acupuncture stimulation, and 15 min VR intervention. The VR intervention is created based on previous reports, and a cylindrical shape with a diameter of 75 cm become a virtual space. A cylindrical shape have alternating white 6.2 cm and black 3.8 cm vertical stripes inside, that is rotated clockwise at a speed of 60 degree per second for 15 minutes to induce optokinetic motion sickness. At this time, the subjects complain of autonomic nervous symptoms and are instructed to remove the VR head set if they could not tolerate it. In electroacupuncture group, we use a sterile stainless acupuncture needle similar to the manual acupuncture group and is inserted perpendicularly to a depth of 15~20 mm under the skin, and Ohm Pulser LFP-2000e (Zen Iryoki Co., Tokyo, Japan) is used to electroacupuncture at 10 Hz for 20 minutes in before VR intervention. The needling sites are performed on ST36 bilaterally located in the tibialis anterior muscle between the head of fibula and the lower end of the tibial tuberosity.
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	18 years-old <=
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	The eligibility criteria for subjects are healthy male volunteers between the ages of 18 and 30.
Key exclusion criteria	The exclusion criteria are: (1) those who were to the hospital and on medication due to underlying medical conditions, (2) those who were unwell due to sleep disorders, (3) those with a history of gastrointestinal disorders and inner ear disorders, central nervous disorders.
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Imai
Organization	Teikyo Heisei University
Division name	Graduate School of Health Sciences
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL	080-1527-1617
Email	k.imai@thu.ac.jp

Public contact
Name of contact person	1st name Daiyu Middle name Last name Shinohara
Organization	Teikyo Heisei University
Division name	Graduate School of Health Sciences
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL	080-5521-6516
Homepage URL
Email	d.shinohara1@gmail.com

Sponsor
Institute	Teikyo Heisei University
Institute
Department

Funding Source
Organization	Teikyo Heisei University
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	Ethical commitie, Teikyo Heisei University
Address	2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
Tel	03-5843-3111
Email	rec@thu.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	2022 Year 07 Month 27 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	No longer recruiting
Date of protocol fixation	2022 Year 04 Month 15 Day
Date of IRB	2022 Year 07 Month 25 Day
Anticipated trial start date	2022 Year 07 Month 29 Day
Last follow-up date	2022 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 26 Day
Last modified on	2022 Year 09 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055237