UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061826 |
|---|---|
| Receipt number | R000070727 |
| Scientific Title | Elucidating the Neurophysiological Mechanisms Underlying Early Motor Learning Following Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex: A Magnetic Resonance Spectroscopy Study |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/06/08 15:43:26 |
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Basic information
Public title
Elucidating the Neurophysiological Mechanisms Underlying Early Motor Learning Following Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex: A Magnetic Resonance Spectroscopy Study
Acronym
Elucidating the Neurophysiological Mechanisms Underlying Early Motor Learning Following Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex
Scientific Title
Elucidating the Neurophysiological Mechanisms Underlying Early Motor Learning Following Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex: A Magnetic Resonance Spectroscopy Study
Scientific Title:Acronym
Elucidating the Neurophysiological Mechanisms Underlying Early Motor Learning Following Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the neurophysiological effects of tDCS applied over the left DLPFC on early motor learning using MRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Purdue Pegboard Test
Magnetic Resonance Spectroscopy (MRS)
Key secondary outcomes
Sensational Questionnaire
Handedness Inventory
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1) Online tDCS group
2 mA for 20 minutes
Interventions/Control_2
2) Offline tDCS group
2 mA for 20 minutes
Interventions/Control_3
3)Sham condition as a placebo control in which stimulation
0 mA for 20 min(2mA for first 1 min)
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. No history of psychiatric or neurological disorders
2. A person who signed a written informed consent
3. Over 70 points on the Edinburgh Handedness Questionnaire Inventory (Oldfield, 1971)
Key exclusion criteria
1. History of developmental disabilities or psychiatric disorders
2. MRI examinations are contraindicated for individuals with magnetic materials or implanted medical devices in their bodies, as well as those with claustrophobia.
3. Individuals with evident neurological deficits attributable to stroke
4. Individuals with an increased risk of bleeding, a history of serious adverse events during blood sampling, skin infection or lesions at the venipuncture site, severe fear of blood sampling that precludes safe collection, or who are pregnant or may be pregnant
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
D.sawamura@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
Homepage URL
D.sawamura@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Ethical review board of Faculty of Health Sciences, Hokkaido University
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
Tel
011-706-3316
shomu@hs.hokudai.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
| 2026 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070727
