UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046868 |
|---|---|
| Receipt number | R000053467 |
| Scientific Title | The effect of transcranial direct current electrical stimulation on the dexterity performance of the non-dominant hand: Double-blind randomized controlled trial |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2023/08/10 20:28:10 |
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Basic information
Public title
The effect of transcranial direct current electrical stimulation on the dexterity performance of the non-dominant hand: Double-blind randomized controlled trial
Acronym
The effect of transcranial direct current electrical stimulation on the dexterity performance of the non-dominant hand
Scientific Title
The effect of transcranial direct current electrical stimulation on the dexterity performance of the non-dominant hand: Double-blind randomized controlled trial
Scientific Title:Acronym
The effect of transcranial direct current electrical stimulation on the dexterity performance of the non-dominant hand
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of tDCS to the left DLPFC on dexterity performance of the non-dominant hand
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Performance of Purdue pegboard test
1.left hand score
2.assembly score
Key secondary outcomes
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
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transcranial direct current stimulation to the left dorsolateral prefrontal cortex
Interventions/Control_2
Sham stimulation to the left dorsolateral prefrontal cortex
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Right-handed healthy adults
2.No history of psychiatric or neurological disorders
3.A person who signed written informed consent
Key exclusion criteria
1.Neurological findings that interfere with the performance of motor tasks
2.History of developmental disabilities or psychiatric disorders
3.Metal (except titanium) or electrical implants in the brain or skull
4.Metal or electronic devices in the body.(e.g. pacemakers, metal remnants from trauma)
5.History of head trauma or organic disease resulting in loss of consciousness
6.History of epileptic seizures or convulsions
7.Pregnant or possibility of pregnant
Target sample size
70
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
011-706-3387
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
011-706-3387
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
北海道大学大学院保健科学研究院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-03989-9
Publication of results
Published
Result
URL related to results and publications
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-03989-9
Number of participants that the trial has enrolled
70
Results
The final sample comprised 66 participants. There were significant interactions between group and time in both PPT tasks, indicating significantly higher performance of those in the active tDCS group than those in the sham group post tDCS. Moreover, a greater benefit was observed in the assembly task performance.
Results date posted
| 2023 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The final sample comprised 66 healthy, right-handed, young adults.
Participant flow
In the active stimulation group (35 subjects), stimulation to elicit cortical excitability of the left DLPFC was performed for about 20 minutes.
Adverse events
The tDCS device used in this study may cause minor itching, erythema, tingling, nerve irritation, etc. at the skin site under the electrodes.
Outcome measures
Performance of Purdue pegboard test
1.left hand score
2.assembly score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | 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 | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053467
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