UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016021 |
|---|---|
| Receipt number | R000018629 |
| Scientific Title | Improving motor disability in stroke with repetitive transcranial magnetic stimulation: A study of movement-related cortical potential (MRCP) |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2014/12/22 11:45:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Improving motor disability in stroke with repetitive transcranial magnetic stimulation: A study of movement-related cortical potential (MRCP)
Acronym
Improvement of motor disability by rTMS
Scientific Title
Improving motor disability in stroke with repetitive transcranial magnetic stimulation: A study of movement-related cortical potential (MRCP)
Scientific Title:Acronym
Improvement of motor disability by rTMS
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effect of repetitive transcranial magnetic stimulation to motor paresis after ischemic stroke using movement-related cortical potential
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. improvement of motor impairment
2. improvement of measures in movement-related cortical potential
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Real stimulation group: This group is treated with five daily 20-minutes sessions of 1 Hz repetitive transcranial magnetic stimulation over the motor cortex in the contralesional hemisphere
Interventions/Control_2
Sham stimulation group: This group is treated with five daily 20-minutes sessions of sham stimulation over the motor cortex in the contralesional hemisphere
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who admitted Shimane University Hospital due to cerebral infarction from January 2012 to December 2013
2. Patients who had a stroke lesion within one hemisphere as verified by magnetic resonance imaging
3. Patients who showed mild to moderate motor deficit in one hand
4. Patients who had cerebral infarction within 30 days
Key exclusion criteria
1. Patients who had dementia
2. Patients who had neuropsychiatric comorbidity other than stroke
3. Patients who had unstable medical disorders
4. Patients who had contraindication to magnetic stimulation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Oguro |
Organization
Shimane University Hosptial
Division name
Department of Neurology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2198
oguro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Tomii |
Organization
Shimane University Hospital
Division name
Clinical Research Center
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2259
Homepage URL
ytomii@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
島根大学医学部附属病院/Shimane University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 24 | 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
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2014 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
