UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050053 |
|---|---|
| Receipt number | R000056975 |
| Scientific Title | Investigation of the effects of peripheral electrical stimulation of the plantar feet on tactile orientation discrimination ablility and cortical excitability. |
| Date of disclosure of the study information | 2023/01/17 |
| Last modified on | 2023/01/17 12:17:00 |
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Basic information
Public title
Investigation of the effects of peripheral electrical stimulation of the plantar feet on tactile orientation discrimination ablility and cortical excitability.
Acronym
Investigation of the effects of peripheral electrical stimulation of the plantar feet on tactile orientation discrimination ablility and cortical excitability.
Scientific Title
Investigation of the effects of peripheral electrical stimulation of the plantar feet on tactile orientation discrimination ablility and cortical excitability.
Scientific Title:Acronym
Investigation of the effects of peripheral electrical stimulation of the plantar feet on tactile orientation discrimination ablility and cortical excitability.
Region
| Japan |
Condition
Condition
healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of peripheral electrical stimulation for the plantar feet on orientation discrimination ability and cortical excitability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in tactile grating orientation discrimination ability
Changes in brain oscillation in resting condition
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Peripheral electrical stimulation for the plantar feet (stimulation intensity: 1.8 times the sensory threshold)
Interventions/Control_2
Peripheral electrical stimulation for the plantar feet (stimulation intensity: 0.5 times the sensory threshold)
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy persons at aged 18-50 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 | Kei |
| Middle name | |
| Last name | Saito |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252501954
kei-saito@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Saito |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252501954
Homepage URL
kei-saito@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
025-257-4455
rinri@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
| 2023 | Year | 01 | Month | 17 | 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
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | 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=R000056975
