UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004737 |
|---|---|
| Receipt number | R000005643 |
| Scientific Title | Study of brain connectivity using repetitive transcranial magnetic stimulation and near infrared spectroscopy |
| Date of disclosure of the study information | 2010/12/17 |
| Last modified on | 2010/12/16 19:35:38 |
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Basic information
Public title
Study of brain connectivity using repetitive transcranial magnetic stimulation and near infrared spectroscopy
Acronym
Study of brain connectivity using rTMS and NIRS
Scientific Title
Study of brain connectivity using repetitive transcranial magnetic stimulation and near infrared spectroscopy
Scientific Title:Acronym
Study of brain connectivity using rTMS and NIRS
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of brain connectivity in schizophrenia
Basic objectives2
Others
Basic objectives -Others
Clarifying the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in hemodynamic response during repetitive transcranial magnetic stimulation between schizophrenia and healthy control
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Repetitive transcranial magnetic stimulation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
DSM-VI diagnosis of schizophrenia, schizoaffective disorder and schizophreniform disorder.
Key exclusion criteria
Past history of epilepsy, neurosurgical disorder and cardiovascural disorder.
Family history of epilepsy.
Presence of ferromagnetic material in or in close proximity to the head or pacemaker.
Patients with pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomikimi Tsuji |
Organization
Wakayama Medical University
Division name
Department of Neuropsychiatry
Zip code
Address
811-1, Kimiidera, Wakayama, Japan
TEL
073-441-0659
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomikimi Tsuji |
Organization
Wakayama Medical University
Division name
Department of Neuropsychiatry
Zip code
Address
811-1, Kimiidera, Wakayama, Japan
TEL
073-441-0659
Homepage URL
tms@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 16 | Day |
Last modified on
| 2010 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005643
| 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 |
