UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045168 |
|---|---|
| Receipt number | R000051594 |
| Scientific Title | The change in inhibitory and facilitatory circuit in primary somatosensory cortex induced by water flow stimulation |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2024/01/17 16:26:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The change in cortical activation induced by water flow stimulation
Acronym
The change in cortical activation induced by water flow stimulation
Scientific Title
The change in inhibitory and facilitatory circuit in primary somatosensory cortex induced by water flow stimulation
Scientific Title:Acronym
The water flow stimulation and neural circuits in S1
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to test our hypothesis that water flow stimulation increases inhibitory neural activity in the primary somatosensory cortex. Based on this results, we test its effectiveness as a method of altering the inhibitory-excitatory balance of the primary somatosensory cortex in a shorter time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
single and paired pulse somatosenosry evoked potentials
Key secondary outcomes
name, age, sex, height, weight, medical history, menstrual cycle
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Control trial
Interventions/Control_2
High frequency-repetitive somatosensory stimulation trial
Stimulus frequency and intensity are 20Hz and the maximal intensity without pain
Interventions/Control_3
water immersion trial
water temperature is 33 degree C
Interventions/Control_4
water flow stimulation trial
water temperature is 33 degree C
output of water flow stimulation is set at 40l/min
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy persons at aged 18-40 y.o.
Key exclusion criteria
Neurological and psychiatric disorders and history of such disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Science
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata City, NIigata
TEL
025-257-4624
daisuke@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Science
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata City, NIigata
TEL
025-257-4624
Homepage URL
daisuke@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
Shimami-cho 1398, Kita-ku, Niigata City, NIigata
Tel
025-257-4624
daisuke@nuhw.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
| 2021 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051594
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
