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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030439
Receipt No. R000034755
Scientific Title Evaluation study for the effect of transcranial direct current stimulatoin on brain function
Date of disclosure of the study information 2018/01/01
Last modified on 2018/10/24

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Basic information
Public title Evaluation study for the effect of transcranial direct current stimulatoin on brain function
Acronym Evaluation study for the effect of tDCS
Scientific Title Evaluation study for the effect of transcranial direct current stimulatoin on brain function
Scientific Title:Acronym Evaluation study for the effect of tDCS
Region
Japan

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

Objectives
Narrative objectives1 To investigate the differences between single and recurrent tDCS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes brain function evaluated by functional MRI at pre and post stimulation
Key secondary outcomes Comparison between pre and post stimulation
higher brain function
degree of fatigue
evaluation for stress

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1. single tDCS (20 minutes)
2. wash-out 48hours
3. single sham stimulation (20 minutes)
Interventions/Control_2 1. single sham stimulation (20 minutes)
2. wash-out 48hours
3. single tDCS (20 minutes)
Interventions/Control_3 1. 10 days tDCS (20 minutes)
2. wash-out 2 weeks
3. 10 days sham stimulation(20 minutes)
Interventions/Control_4 1. 10 days sham stimulation (20 minutes)
2. wash-out 2 weeks
3. 10 days tDCS (20 minutes)
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
40 years-old >
Gender Male and Female
Key inclusion criteria Subjects who have the ability to provide informed consent and adhere to the protocol.
Key exclusion criteria - Subject with past or current history of psychiatric illness
- Subject with past or current history of serious medical illness and/or brain organic diseases
- Subject who is contraindicated for the use of MRI
- Subject with past or current history ofsevere liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subject who are judged as not suitable for participation in this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiro Okubo, M.D., Ph.D.
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL +81-3-3822-2131
Email okubo-y@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Amane Tateno, M.D., Ph.D.
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL +81-3-3822-2131
Homepage URL
Email amtateno@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization anti-doping consortium
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
Address
Tel
Email

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
2018 Year 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 07 Month 31 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 17 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034755

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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