UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048128 |
|---|---|
| Receipt number | R000054848 |
| Scientific Title | Development of novel non-invasive brain stimulation using transcranial alternating current stimulation and transcranial magnetic stimulation |
| Date of disclosure of the study information | 2022/06/21 |
| Last modified on | 2024/11/21 22:38:21 |
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Basic information
Public title
Development of novel non-invasive brain stimulation for inducing the neuronal plasticity in the motor area
Acronym
Development of novel non-invasive brain stimulation for inducing the neuronal plasticity in the motor area
Scientific Title
Development of novel non-invasive brain stimulation using transcranial alternating current stimulation and transcranial magnetic stimulation
Scientific Title:Acronym
Development of novel non-invasive brain stimulation using transcranial alternating current stimulation and transcranial magnetic stimulation
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the neural mechanism underlying the combined stimulation of tACS and rPPS on the primary motor area
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MEP amplitudes induced by single-pulse and paired-pulse TMS before and after combined stimulation.
Finger tapping and the neural oscillation related to movement using EEG.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
rPPS combined with 20 Hz tACS at the 90 deg phase
Interventions/Control_2
rPPS alone
Interventions/Control_3
tACS alone
Interventions/Control_4
rPPS combined with 20 Hz tACS at the 270 deg phase
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Right-handed healthy adults
2. Participants who agree to participate in this study
Key exclusion criteria
1. Participants with a history of neurological or psychiatric disorders
2. Participants with implanted metal devices
3. Pregnant women
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Nakazono |
Organization
Fukuoka International University of Health and Welfare
Division name
Department of Occupational Therapy, Faculty of Medical Science
Zip code
814-0001
Address
3-6-40 Momochihama, Sawaraku, Fukuoka, Japan
TEL
092-832-1200
nakazono@takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Hisato |
| Middle name | |
| Last name | Nakazono |
Organization
Fukuoka International University of Health and Welfare
Division name
Department of Occupational Therapy, Faculty of Medical Science
Zip code
814-0001
Address
3-6-40 Momochihama, Sawaraku, Fukuoka, Japan
TEL
092-832-1200
Homepage URL
nakazono@takagigakuen.ac.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Fukuoka International 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
Fukuoka International University of Health and Welfare ethics review committee
Address
3-6-40 Momochihama, Sawaraku, Fukuoka, Japan
Tel
092-832-1200
fiuhw-rinri@takagigakuen.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 | 06 | Month | 21 | 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
| 2022 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2027 | 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 | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054848
