UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052785 |
|---|---|
| Receipt number | R000060235 |
| Scientific Title | Effects of transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex on frustration-induced aggression modulation -A double-blind randomized controlled trial- |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2023/11/14 20:25:17 |
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Basic information
Public title
Effects of transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex on frustration-induced aggression modulation -A double-blind randomized controlled trial-
Acronym
Effects of transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex on frustration-induced aggression modulation
Scientific Title
Effects of transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex on frustration-induced aggression modulation -A double-blind randomized controlled trial-
Scientific Title:Acronym
Effects of transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex on frustration-induced aggression modulation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of tDCS on frustration-induced aggression in the left VLPFC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1. Aggressiveness Assessment Tools(Competitive reaction-time task, Sequence Chosen Task, Tangram Task)
2. Heart rate
3. skin conductance
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
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Anodal transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex
Interventions/Control_2
Cathodal transcranial direct current electrical stimulation to the left ventrolateral prefrontal cortex
Interventions/Control_3
Sham stimulation to the left ventrolateral prefrontal cortex
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. 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 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
90
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
Daisuke Sawamura
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
(non-US)
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Faculty of Health Sciences at 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
| 2023 | Year | 11 | Month | 15 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060235
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
