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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048128
Receipt No. 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 2022/06/21

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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 3
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
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
Email 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
Email nakazono@takagigakuen.ac.jp

Sponsor
Institute Fukuoka International University of Health and Welfare
Institute
Department

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
Email 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
2022 Year 06 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054848

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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