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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015953
Receipt No. R000018556
Scientific Title A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Date of disclosure of the study information 2015/12/15
Last modified on 2016/06/15

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Basic information
Public title A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Acronym The effect of transcranial direct current stimulation in schizophrenia
Scientific Title A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Scientific Title:Acronym The effect of transcranial direct current stimulation in schizophrenia
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of tDCS on cognitive function and depressive symptoms in patients with schizophrenia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Brief Assessment of Cognitive function in Schizophrenia Japanese version
Key secondary outcomes CDSS(Calgary Depression Scale for Schizophrenics)
PANSS(Positive and Negative Syndrome Scale)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 transcranial direct current stimulation
(twice daily for 5 days)
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria (1)Meeting DSM-5 criteria for shiczophrenia

(2)Able to understand the purposes and nature of the study and provide consetnt to agree to participate in it
Key exclusion criteria (1)Having severe organic brain regions, head trauma with consciousness loss lasting more than 10 minutues, and/or present or past history of epilepsy

(2) Having alcohol or other substances abuse (excluding caffeine and nicotine) witnin 12 months of the baseline assessment

(3)Contra-indicated to ECT or tDCS (e.g. history of brain injury)

(4) Unqualified to the study based on the investigator's judgment
Target sample size 30

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 187-8551 Japan
TEL +81-42-341-2711
Email sumiyot@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuko Iwase
Organization National Center of Neurology and Psychiatry
Division name Translational Medical Center
Zip code
Address 4-1-1- Ogawahigashi, Kodaira, Tokyo 187-8551 Japan
TEL +81-42-341-2711
Homepage URL
Email iwase@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japanese Society of the Promotion of Sciences
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 YES
Study ID_1 A2014-100
Org. issuing International ID_1 National Center of Neurology and Psychiatry
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立精神・神経医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 15 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 Preinitiation
Date of protocol fixation
2014 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 05 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 15 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 12 Month 15 Day
Last modified on
2016 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018556

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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