UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058316 |
|---|---|
| Receipt number | R000066673 |
| Scientific Title | Investigation of Interventions to Enhance Balance Function Using Non-Invasive Brain Stimulation Targeting Motor-Related Areas |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/07/11 15:49:55 |
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Basic information
Public title
Investigation of Balance Improvement through Electrical Stimulation Targeting Motor-Related Brain Regions
Acronym
Investigation of Balance Improvement through Electrical Stimulation Targeting Motor-Related Brain Regions
Scientific Title
Investigation of Interventions to Enhance Balance Function Using Non-Invasive Brain Stimulation Targeting Motor-Related Areas
Scientific Title:Acronym
Investigation of Interventions to Enhance Balance Function Using Non-Invasive Brain Stimulation Targeting Motor-Related Areas
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of transcranial direct current stimulation on cross-education
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
balance evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Anodal tDCS applied to the primary motor cortex
Interventions/Control_2
Cathodal tDCS applied to the primary motor cortex
Interventions/Control_3
Sham tDCS applied to the primary motor cortex
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participants will be students enrolled in this university or its graduate school who voluntarily agree to participate in the experiment after the principal investigator provides an explanation of the study outline
Key exclusion criteria
Individuals will be excluded if they have any of the following: neurological or psychiatric disorders; metallic implants or electronic devices such as pacemakers in the body; are taking neuroactive medications; or have injuries or fractures in the lower limbs.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirose |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
hpm24001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirose |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
Homepage URL
hpm24001@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 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
hpm24001@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
| 2025 | Year | 07 | Month | 01 | 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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066673
