UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051429 |
|---|---|
| Receipt number | R000058623 |
| Scientific Title | Investigation of neurophysiological effects of oscillatory transcranial direct current stimulation over the motor-related cortex area during gait |
| Date of disclosure of the study information | 2023/06/28 |
| Last modified on | 2024/06/24 19:13:05 |
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Basic information
Public title
Investigation of neurophysiological effects of oscillatory transcranial direct current stimulation over the motor-related cortex area during gait
Acronym
Investigation of effects of oscillatory transcranial direct current stimulation during gait
Scientific Title
Investigation of neurophysiological effects of oscillatory transcranial direct current stimulation over the motor-related cortex area during gait
Scientific Title:Acronym
Investigation of effects of oscillatory transcranial direct current stimulation during gait
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neurophysiological effects of oscillatory transcranial direct current stimulation during gait
Basic objectives2
Others
Basic objectives -Others
To investigate the neurophysiological effects of oscillatory transcranial direct current stimulation during gait
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyographical parameters
Gait parameters
Neurophysiological parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Alpha-band stimulation over the primary motor cortex
Interventions/Control_2
Beta-band stimulation over the primary motor cortex
Interventions/Control_3
Alpha-band stimulation over the motor-related areas
Interventions/Control_4
Beta-band stimulation over the motor-related areas
Interventions/Control_5
Sham stimulation
Interventions/Control_6
Transcranial direct current stimulation
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
Right-hand and leg dominant
Understand the instructions
Key exclusion criteria
Present or history of orthopedic and neurological disorders
History of epileptic seizures
Pacemaker in the body
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kitatani |
Organization
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, Niigata
TEL
025-257-4309
ryosuke-kitatani@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kitatani |
Organization
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, Niigata
TEL
025-257-4309
Homepage URL
ryosuke-kitatani@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
Japan
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, 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 | 06 | Month | 28 | 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
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058623
