UMIN-CTR Clinical Trial

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 Yoshiro Middle name Last name Okubo
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8602
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 Amane Middle name Last name Tateno
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8602
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	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel	+81-3-3822-2131
Email	clinicaltrial@nms.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	2018 Year 01 Month 01 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/10.1111/pcn.13208
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/pcn.13208
Number of participants that the trial has enrolled	19
Results	Reaction times of the implicit motor learning task were significantly faster with tDCS in comparison with the sham. Further, language-related left prefrontal-parahippocampal-parietal activation was significantly less with tDCS compared with the sham. Significant correlation was observed between shortened response time in serial reaction time task and decreased cerebral activation during VFT with tDCS.
Results date posted	2022 Year 06 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Nineteen healthy volunteers (eight females; mean age 23.1　years).
Participant flow	Nineteen healthy volunteers participated in the present study. Informed consent was obtained from all participants. Three participants were excluded due to mistakes with the motor learning task. A total of 16 participants were thus eventually included in the analyses.
Adverse events	none
Outcome measures	Motor learning task: 1. serial reaction time task 2. sequential finger tapping task verbal fluency test functional imaging by MRI
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 27 Day
Date of IRB	2017 Year 12 Month 04 Day
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	2022 Year 06 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034755