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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000027051
Receipt No. R000031009
Scientific Title Clinical study of repetitive transcranial magnetic stimulation in stroke patient with apathy
Date of disclosure of the study information 2017/04/18
Last modified on 2017/04/18

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Basic information
Public title Clinical study of repetitive transcranial magnetic stimulation in stroke patient with apathy
Acronym rTMS for post stroke apathy
Scientific Title Clinical study of repetitive transcranial magnetic stimulation in stroke patient with apathy
Scientific Title:Acronym rTMS for post stroke apathy
Region
Japan

Condition
Condition post stroke apathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of transcranial repetitive timing stimulation for apathy patients after cerebral infarction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) apathy scale
2) Mini Mental State Examination
3) Frontal Assement Battery
4) Self Rating DepressionScale
5) MRI, resting fMRI
6) vitality index, Functional Independence Measure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 real rTMS group ; 110% MT intensity, frequencies 5 Hz, 10 seconds for 10 seconds, supplementary motor area for a total of 500 times / day for 10 days
Interventions/Control_2 sham rTMS group ; the coil is applied vertical to the scalp with the same condition as real rTMS group
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)one week after the onset of cerebral infarction, the general condition is stable.
2)Apathy scale is 16 points or more.
3)gave written informed consent
Key exclusion criteria 1)past history of seizure
2)serious cardiac disorder
3)artificial cardiac pacemaker
4)pregnant
5)Cerebral hypertension
6)Skin symptoms of the scalp
7)severe dementia (MMSE 15 or less)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Abe
Organization Shimane University Hospital
Division name Department of Neurology
Zip code
Address Enyachou 89-1, Izumo city, Shimane
TEL 0853-20-2198
Email sabe@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Abe
Organization Shimane University Hospital
Division name Department of Neurology
Zip code
Address Enyachou 89-1, Izumo city, Shimane
TEL 0853-20-2198
Homepage URL
Email sabe@med.shimane-u.ac.jp

Sponsor
Institute Department of Neurology, Shimane University Hospital
Institute
Department

Funding Source
Organization Department of Neurology, Shimane University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 04 Month 18 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 Suspended
Date of protocol fixation
2017 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 05 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
2017 Year 04 Month 18 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031009

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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