UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058030 |
|---|---|
| Receipt number | R000066328 |
| Scientific Title | Alterations of physiological indices by transcranial direct current stimulation in psychiatric disorders: Evaluation of treatment outcome using autonomic, EEG and blood flow analyses |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/30 18:55:35 |
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Basic information
Public title
Alterations of physiological indices by transcranial direct current stimulation in psychiatric disorders: Evaluation of treatment outcome using autonomic, EEG and blood flow analyses
Acronym
Physiological changes by tDCS
Scientific Title
Alterations of physiological indices by transcranial direct current stimulation in psychiatric disorders: Evaluation of treatment outcome using autonomic, EEG and blood flow analyses
Scientific Title:Acronym
Physiological changes by tDCS
Region
| Japan |
Condition
Condition
depression, bipolar disorder, anxiety disorder, stress disorder, dementia, delirium, neurodevelopmental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to promote the usefulness of transcranial direct current sitmulation in the treatment of psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The phyiological indices include heart rate variability, skin conductance, skin temperature, EEG trhthms, event-related potentials, and brain hemoglobin concentration.
The changes of these indices during and after the tDCS treatment are clarifed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For tDCS, DC current of 0.5-2 mA is passed between the frontal and occipital areas of the brain with altered polarity for 5 to 30 minutes (DC-Stimulator, neuroConn Co.). When adverse effects have occurred, the recording will be promptly halted.
Autonomic indices are measured although the experiment (heart rate variability: RF-ECG2, GM3, skin conductance: Bioderm, UFI Co., brain hemoglobin concentration: TRS-10, Hamamatsu Photonics). The were measured both at rest and during task performance, such as Go/NoGo paradigm, and were analyzed to evaluate the effects of tDCS.
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are enrolled when they are diagnosed with depression, bipolar disorder, anxiety disorder, stress disorder, demential, delirium, and neurodevelo enrolled when they are diagnosed with depression, bipolar disorder, anxiety
Key exclusion criteria
The subjects are not included when they have serious somatic disorders, and when they have drunk alcohol on the day of measurement.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshikazu |
| Middle name | |
| Last name | Shinba |
Organization
Shizuoka Saiseikai General Hospital
Division name
Department of Psychiatry
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka, Japan
TEL
+81542856171
t156591@siz.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Toshikazu |
| Middle name | |
| Last name | Shinba |
Organization
Shizuoka Saiseikai General Hospital
Division name
Department of Psychiatry
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka, Japan
TEL
+81542856171
Homepage URL
t156591@siz.saiseikai.or.jp
Sponsor or person
Institute
Shizuoka Saiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Saiseikai General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Saiseikai General Hospital
Address
1-1-1 Oshika, Suruga-ku, Shizuoka, Japan
Tel
0542856171
t156591@siz.saiseikai.or.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
| 2025 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2035 | 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
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066328
