UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015046 |
|---|---|
| Receipt number | R000017493 |
| Scientific Title | Investigating the changing of quantitative Electroencephalogram (EEG), cognitive and emotional function through using translated Direct Current Stimulation (tDCS) in patients with depression |
| Date of disclosure of the study information | 2014/09/04 |
| Last modified on | 2020/09/10 04:38:07 |
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Basic information
Public title
Investigating the changing of quantitative Electroencephalogram (EEG), cognitive and emotional function through using translated Direct Current Stimulation (tDCS) in patients with depression
Acronym
The effect of tDCS evaluated by qEEG: CEED-D study
Scientific Title
Investigating the changing of quantitative Electroencephalogram (EEG), cognitive and emotional function through using translated Direct Current Stimulation (tDCS) in patients with depression
Scientific Title:Acronym
The effect of tDCS evaluated by qEEG: CEED-D study
Region
| Japan |
Condition
Condition
Major depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the dysfunctional neural network in patients with depression, we will compare the quantitative EEG data and the result of cognitive and emotional tests which are recorded before and after tDCS, and detect the difference of these two groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative EEG, HAM-D, Wisconsin card sorting test(WCST), Assessing Positive and Negative Affect via Self-Report(PANAS)
Key secondary outcomes
MADRS, STAI
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
stimulation for DLPFC using tDCS in patients with depression
Interventions/Control_2
stimulation for MPFC using tDCS in patients with depression
Interventions/Control_3
stimulation for DLPFC using tDCS in normal control
Interventions/Control_4
stimulation for MPFC using tDCS in normal control
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
18-75 years of age, who met the DSM-IV
Criteria for Major Depressive Disorder (mild and moderate state).
Key exclusion criteria
1. The subjects who met criteria for bipolar, psychotic disorder, or personality disorders.
2. subjects who suffered from neurodegenerative disorders and cognitive disorder, including Parkinson disease, intradural hematoma, normal pressure hydrocephalus, brain tumor, apoplexy, epilepsy, history of seizures, brain
surgery, or significant head trauma
3. hormone abnormality including hypothyroidism, autoimmune disease, cardiovascular, hematology, nervous system, endcroine, liver, kidney disease with clinical importance
4. subjects who has pace makers, stimulation brain devices, ventriculo-peritoneal shunt, artificial organ
5. subjects who are judged as unsuitable case by medical doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nishida |
| Middle name | |
| Last name | Keiichiro |
Organization
Kansai Medical University
Division name
Neuropsychiatry
Zip code
570-8506
Address
10-15 Fumizono-cho, Moriguchi-City, Osaka
TEL
+81-6-6992-1001
nishidak@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Nishida |
Organization
Kansai Medical University
Division name
Nuropsychiatry
Zip code
570-8506
Address
10-15 Fumizono-cho, Moriguchi-City, Osaka
TEL
+81-6-6992-1001
Homepage URL
nishidak@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number 26860950
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1 Shin-machi, Hirakata City, Osaka
Tel
+81-72-804-2325
sangaku@hirakata.kmu.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
| 2014 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017493
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
