UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030439 |
|---|---|
| Receipt number | 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 | 2022/06/22 12:43:46 |
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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 | 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
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
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034755
