UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059695 |
|---|---|
| Receipt number | R000068273 |
| Scientific Title | A Pilot Study on Non-invasive Electrical Nerve Stimulation Therapy for Motion Sickness |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/08 11:34:30 |
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Basic information
Public title
Exploring a New Non-invasive Treatment for Motion Sickness Using Electrical Nerve Stimulation
Acronym
Exploring a New Non-invasive Treatment for Motion Sickness Using Electrical Nerve Stimulation
Scientific Title
A Pilot Study on Non-invasive Electrical Nerve Stimulation Therapy for Motion Sickness
Scientific Title:Acronym
A Pilot Study on Non-invasive Electrical Nerve Stimulation Therapy for Motion Sickness
Region
| Japan |
Condition
Condition
Motion Sickness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This pilot study aims to investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) in patients with motion sickness, assessed by subjective (MSAQ) and objective (VST) parameters. The study seeks to elucidate the therapeutic potential of TENS and to contribute to the establishment of a novel, non-invasive treatment modality for motion sickness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, post-rotatory nystagmus will be recorded for one minute following a rotational stimulation at 60degrees/sec under both conditions: with and without TENS application.
From the obtained slow phase eye velocity (SPEV), the time required for the SPEV to decay to 37% of the maximal value (MaxSPEV) will be calculated as the time constant.
Vestibular responses with and without TENS will be compared. Statistical analysis will be performed using the Wilcoxon signed-rank test to evaluate differences between conditions.
Key secondary outcomes
The Motion Sickness Assessment Questionnaire (MSAQ) scores will be compared between the TENS and non-TENS conditions to evaluate subjective changes in motion sickness symptoms induced by TENS.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Under the TENS-off condition, rotational stimulation at 60 degrees/sec will be applied for one minute, followed by one minute of post-rotatory nystagmus recording. The intervention will be conducted only once, and the total duration including post-measurement questionnaire completion will be approximately 10 minutes.
Interventions/Control_2
Under the TENS-on condition, rotational stimulation at 60 degrees/sec will be applied for one minute, followed by one minute of post-rotatory nystagmus recording. The intervention will be conducted only once, and the total duration including post-measurement questionnaire completion will be approximately 10 minutes.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women aged 18 years or older who have provided informed consent and do not meet any of the exclusion criteria.
Key exclusion criteria
Individuals with a history of vestibular dysfunction
Individuals using a pacemaker
Individuals with a history of severe motion sickness
Individuals with skin conditions that make transcutaneous electrical nerve stimulation (TENS) difficult to apply
Pregnant individuals
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Komori |
Organization
St. Marianna University School of Medicine
Division name
Otolaryngology
Zip code
216-8511
Address
Kanagawa Kawasaki-shi Miyamae-ku Sugao 2-16-1
TEL
044-977-8111
manabu.komori@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Nayu |
| Middle name | |
| Last name | Yokoyama |
Organization
St. Marianna University School of Medicine
Division name
Otolaryngology
Zip code
216-8511
Address
Kanagawa Kawasaki-shi Miyamae-ku Sugao 2-16-1
TEL
044-977-8111
Homepage URL
nayu.yokoyama@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Manabu Komori
Funding Source
Organization
Japanese Society of Pediatric Otolaryngology Pegasus Fund
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
St. Marianna University School of Medicine
Address
Kanagawa Kawasaki-shi Miyamae-ku Sugao 2-16-1
Tel
044-977-8111
m_sawa@marianna-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
| 2025 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068273
