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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029548
Receipt No. R000033759
Scientific Title Induction of plasticity in the primary motor area using transcranial alternating current stimulation and transcranial magnetic stimulation.
Date of disclosure of the study information 2017/10/16
Last modified on 2020/04/05

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Basic information
Public title Induction of plasticity in the primary motor area using transcranial alternating current stimulation and transcranial magnetic stimulation.
Acronym Induction of plasticity in the primary motor area using tACS and TMS
Scientific Title Induction of plasticity in the primary motor area using transcranial alternating current stimulation and transcranial magnetic stimulation.
Scientific Title:Acronym Induction of plasticity in the primary motor area using tACS and TMS
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to investigate the effects of combining patterned rTMS and tACS on primary motor area excitability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changing in motor evoked potential amplitudes
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 Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Repetitive paired pulse TMS (rPPS) is combined with 20 Hz tACS different phases (90, 270 deg), and the effects of combined stimulation are compared with the effects of rPPS alone.
Interventions/Control_2 Intermittent theta burst stimulation (iTBS) is combined with 20 Hz tACS different phases (90, 270 deg), and the effects of combined stimulation are compared with the effects of iTBS alone.
Interventions/Control_3 Repetitive paired pulse TMS (rPPS) is combined with 10 Hz tACS different phases (90, 270 deg), and the effects of combined stimulation are compared with the effects of rPPS 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
20 years-old <=
Age-upper limit

Not applicable
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 history of neurological disease
2. Participants with implanted metal devices
3. Pregnant women
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Katsuya
Middle name
Last name Ogata
Organization International University of Health and Welfare
Division name Department of Pharmaceutical Science at Fukuoka
Zip code 831-8501
Address 137-1 Enokizu, Okawa, Fukuoka 891-8501 Japan
TEL 0944-89-2000
Email ogata_k@iuhw.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 City, 814-0001 Japan
TEL 092-832-1200
Homepage URL
Email nakazono@takagigakuen.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization grants JSPS KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and Welfare,Institutional Review Board
Address 137-1 Enokizu, Okawa, Fukuoka City, 891-8501 Japan
Tel 0944-89-2000
Email ogata_k@iuhw.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
2017 Year 10 Month 16 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
2017 Year 10 Month 13 Day
Date of IRB
2017 Year 10 Month 13 Day
Anticipated trial start date
2017 Year 10 Month 16 Day
Last follow-up date
2021 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
2017 Year 10 Month 13 Day
Last modified on
2020 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033759

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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