UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049102 |
|---|---|
| Receipt number | R000055936 |
| Scientific Title | Effects of transcranial direct current stimulation and transcranial random noise stimulation on the inhibition of visual cross-modal distractors |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2024/03/11 16:06:44 |
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Basic information
Public title
Effects of transcranial direct current stimulation and transcranial random noise stimulation on the inhibition of visual cross-modal distractors
Acronym
Effects of tDCS and tRNS on the inhibition of visual cross-modal distractors
Scientific Title
Effects of transcranial direct current stimulation and transcranial random noise stimulation on the inhibition of visual cross-modal distractors
Scientific Title:Acronym
Effects of tDCS and tRNS on the inhibition of visual cross-modal distractors
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tDCS and tRNS on the inhibition of visual cross-modal distractors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Auditory working memory task
Electroencephalogram (EEG)
Key secondary outcomes
Sensational Questionnaire
Handedness Inventory
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
All subjects will perform an auditory working memory task in three conditions: 1) prefrontal tDCS condition, 2) prefrontal tRNS+DC-offset condition, and 3) Sham condition as a placebo control in which stimulation is administered for only the first minute.
In the active stimulation group(1 and 2), a current stimulation was delivered at 2 mA for 20-min. In the sham group, sham stimulation consisted of a 60- s stimulation delivered at the beginning of the 20 min (30-s ramp-up and ramp-down) and 0 mA for the remainder of the period.
Interventions/Control_2
2)prefrontal tRNS condition
2 mA for 20 min(2mA for first 1 min)
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
Inclusion criteria were 1) age range 18-30 years, 2) over 70 points on the Edinburgh Handedness Questionnaire Inventory (Oldfield, 1971) and 3) no experience conducting auditory working memory tasks with visual cross-modal distractors.
Key exclusion criteria
Exclusion criteria were 1) the history of neurological or psychiatric disorders and 2) functional limitations of both or either upper limb that influence the task performance.
Target sample size
46
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 Sciences
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-Ku
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
Department of Rehabilitation Sciences
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-Ku
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
Kita 12, Nishi 5, 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
| 2022 | Year | 11 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055936
