UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027051 |
|---|---|
| Receipt number | 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 | 2021/04/21 15:46:35 |
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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
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
sabe@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Shimane University Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031009
