UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056237 |
|---|---|
| Receipt number | R000063442 |
| Scientific Title | Effects of Cervical Transcutaneous Interferential Current Stimulation on Brain Regulatory Mechanisms |
| Date of disclosure of the study information | 2024/11/22 |
| Last modified on | 2025/11/25 07:18:45 |
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Basic information
Public title
Effects of Cervical Transcutaneous Interferential Current Stimulation on Brain Regulatory Mechanisms
Acronym
Effects of Cervical Transcutaneous Interferential Current Stimulation on Brain Regulatory Mechanisms
Scientific Title
Effects of Cervical Transcutaneous Interferential Current Stimulation on Brain Regulatory Mechanisms
Scientific Title:Acronym
Effects of Cervical Transcutaneous Interferential Current Stimulation on Brain Regulatory Mechanisms
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the Effects of cervical transcutaneous interferential current stimulation on brain regulatory mechanisms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive-motor task
Key secondary outcomes
1)Salivary amylase activity
2)Autonomic nervous function calculated from heart rate variability
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
interferential current stimulation
Interventions/Control_2
transauricular vagus nerve stimulation
Interventions/Control_3
Sham 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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following criteria must be met:
1.A healthy adult aged 18 or older.
2.Someone who has expressed interest in participating in this study after seeing recruitment posters displayed in the Hiroshima University School of Medicine Research Building and the School of Health Sciences Research Building.
3.Someone who can provide written consent to participate in this study.
Key exclusion criteria
1.Individuals with a history or comorbidities of central nervous system, neuromuscular, or cardiovascular diseases.
2.Individuals with metal implants (such as implants, pacemakers, cochlear implants, etc.) in their body.
3.Pregnant women.
4.Individuals with a conflict of interest, such as those enrolled in lectures given by the principal investigator or co-investigators.
5.Other individuals deemed unsuitable by the principal investigator or co-investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nezu |
Organization
Hiroshima University
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
7348551
Address
1-2-3 Kasumi, Minami ward, Hiroshima
TEL
+81-82-257-5201
tomonezu@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nezu |
Organization
Hiroshima University
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
7348551
Address
1-2-3 Kasumi, Minami ward, Hiroshima
TEL
+81-82-257-5201
Homepage URL
tomonezu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Nakatomi Foundation
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 11 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063442
