UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048366 |
|---|---|
| Receipt number | R000055126 |
| Scientific Title | Effects of combination of transcranial alternating current stimulation and peripheral somatosensory stimulation on cortical activity and sensory function. |
| Date of disclosure of the study information | 2022/07/13 |
| Last modified on | 2022/07/13 17:33:37 |
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Basic information
Public title
Effects of combination of transcranial alternating current stimulation and peripheral somatosensory stimulation on cortical activity and sensory function.
Acronym
Effects of combination of transcranial alternating current stimulation and peripheral somatosensory stimulation on cortical activity and sensory function.
Scientific Title
Effects of combination of transcranial alternating current stimulation and peripheral somatosensory stimulation on cortical activity and sensory function.
Scientific Title:Acronym
Effects of combination of transcranial alternating current stimulation and peripheral somatosensory stimulation on cortical activity and sensory function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the combined effects of transcranial alternating current stimulation and peripheral electrical stimulation of the median nerve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Somatosensory evoked potential, two-point discrimination
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conditions for combining peripheral electrical stimulation of the median nerve with transcranial alternating current stimulation for 20-30 minutes.
Interventions/Control_2
Conditions for combining peripheral electrical stimulation of the median nerve with transcranial alternating current stimulation differently from Intervention_1 for 20-30 minutes.
Interventions/Control_3
Conditions that add only peripheral electrical stimulation to the median nerve for 20-30 minutes.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who have seen the e-mail recruiting experimental subjects and who voluntarily wished to participate in the experiment.
Key exclusion criteria
Exclusion criteria are pregnant women, patients on dialysis, taking neuro-active drugs, having metal or electronic devices in the body, previous epileptic seizures, nerve damage, skin disease at the location of electrode application, and previous orthopedic disease in the hand.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Maruyama |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hpm22007@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Maruyama |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hpm22007@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
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
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
| 2022 | Year | 07 | Month | 13 | 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 | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | 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
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055126
