UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020583 |
|---|---|
| Receipt number | R000023446 |
| Scientific Title | Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/06/18 16:00:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects
Acronym
Effect of tDCS on the dopamine-GABA systems in healthy subjects
Scientific Title
Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects
Scientific Title:Acronym
Effect of tDCS on the dopamine-GABA systems in healthy subjects
Region
| Japan |
Condition
Condition
psychiatric and neurological disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect of transcranial direct current stimulation(tDCS) on the dopamine-GABA systems, using raclopride PET and Magnetic Resonance Spectroscopy(MRS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Analyze changes in binding potential of [11C]raclopride in PET and GABA levels in MRS between tDCS and sham stimulation conditions.
Key secondary outcomes
Analyze changes of cognitive test scores between tDCS and sham stimulation conditions.
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
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Anodal and cathodal electrodes are placed at the left frontal areas and right frontal areas, respectively. 13-min tDCS with a current intensity of 2 mA is applied twice with a 20-min. After more than a month, sham stimulation is applied. With the same electrodes placed as in the true stimulation condition, sham stimulation is switched off 30 seconds after stimulation start. After each stimulation, raclopride PET and MRS is performed.
Interventions/Control_2
First, sham stimulation is applied. After more than a month, true stimulation is applied. After each stimulation, raclopride PET and MRS is performed.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1.Healthy right-handed man over twenty years of age
2.With intelligence score IQ>80 on the Japanese Adult Reading Test
3.People who have consent to participate in this research
Key exclusion criteria
1.People with a history of traumatic brain injury and a episode of an unconsciousness lasting more than 5 minutes
2.People with a history of organic brain diseases
3.People with a history of seizure
4.People with chronic headache
5.People who cannot undergo an MRI scan
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ouchi yasuomi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofunctional Imaging
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | bunai tomoyasu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofunctional Imaging
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
Homepage URL
bunai.t@hama-med.ac.jp
Sponsor or person
Institute
Department of Biofunctional Imaging, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Scholarship donations
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
浜松PET診断センター、浜松ホトニクス（静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 15 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023446
