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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024752
Receipt No. R000028446
Scientific Title Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders
Date of disclosure of the study information 2016/12/01
Last modified on 2017/05/09

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Basic information
Public title Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders
Acronym Effect of repetitive transcranial magnetic stimulation (rTMS)
Scientific Title Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders
Scientific Title:Acronym Effect of repetitive transcranial magnetic stimulation (rTMS)
Region
Japan

Condition
Condition patients with depressive state who meet criteria for mood disorders or schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of rTMS (real or sham stimulation) on brain morphology and function in patients with depressive state who meet criteria of mood disorders or schizophrenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Hamilton Rating Scale for Depression
Key secondary outcomes Beck Depression Inventory
Brief Assesment of Cognition in Schizophrenia-Japanese version(BACS-J)
brain MRI
brain SPECT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 1)real rTMS (20Hz), 2000 pulses per session
2)five treatment sessions per week during a period of four to six weeks
Interventions/Control_2 1)sham rTMS
2)five treatment sessions per week during a period of four to six weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)patient with depressive state, who meets ICD-10 criteria for mood disorders or schizophrenia
2)non responder to medication for over half a year
3)20 years of age or over
4)gave written informed consent
Key exclusion criteria 1)past history of seizure
2)intracerebral metal
3)dependence on alcohol
4)serious cardiac disorder
5)cochlea implant
6)artificial cardiac pacemaker
7)infusion pump
8)any other patients who are regarded as unsuitable for this study by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Higuchi
Organization University of Toyama
Division name Department of Neuropsychiatry
Zip code
Address 2630 Sugitani, Toyama
TEL 076-434-7323
Email yhiguchi@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Higuchi
Organization University of Toyama
Division name Department of Neuropsychiatry
Zip code
Address 2630 Sugitani, Toyama
TEL 076-434-7323
Homepage URL
Email yhiguchi@med.u-toyama.ac.jp

Sponsor
Institute Department of Neuropsychiatry, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Neuropsychiatry, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor N/A
Name of secondary funder(s) N/A

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 富山大学附属病院/Toyama University Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 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
2016 Year 11 Month 08 Day
Last modified on
2017 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028446

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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