UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028224 |
|---|---|
| Receipt number | R000032305 |
| Scientific Title | A randomized controlled trial on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia |
| Date of disclosure of the study information | 2017/07/13 |
| Last modified on | 2017/07/13 21:15:10 |
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Basic information
Public title
A randomized controlled trial on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Acronym
A randomized controlled trial on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Scientific Title
A randomized controlled trial on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Scientific Title:Acronym
A randomized controlled trial on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial aims to evaluate the effect of transcranial direct current stimulation on functional aspects in patients with schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores on the UCSD Performance-based Skills Assessment-Brief one month later from the last tDCS administration
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intensity: 2 mA
Frequency:twice daily for 5 consecutive days
Duration:20 minute/stimulation
Interventions/Control_2
sham-stimulation
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Meeting DSM-5 criteria for schizophrenia
Key exclusion criteria
Alcohol or substance disorder
Traumatic brain injury
Epilepsy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomiki Sumiyoshi |
Organization
National Center of Neurology and Psychiatry
Division name
Translational Medical Center
Zip code
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL
0423412711
sumiyot@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Sueyoshi |
Organization
National Ctr Neurol Psychiatr
Division name
Translational Medical Center
Zip code
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL
0423412711
Homepage URL
sueyosi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | 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
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2017 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032305
| 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 |
