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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028224
Receipt No. 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

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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
Email 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
Email sueyosi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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