UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008663 |
|---|---|
| Receipt number | R000010181 |
| Scientific Title | The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation |
| Date of disclosure of the study information | 2012/08/10 |
| Last modified on | 2016/08/14 16:39:04 |
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Basic information
Public title
The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation
Acronym
The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation
Scientific Title
The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation
Scientific Title:Acronym
The short-term efficacy of very low-frequency repetitive transcranial magnetic stimulation (rTMS) over the unaffected motor cortex on post-stroke patients with spasticity recieving botulinum toxin injection and rehabilitation
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Medicine in general | Neurology | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of very low-frequency repetitive transcranial magnetic stimulation over the unaffected motor cortex in post-stroke patients with spasticity recieving botulinum toxin injection and rehablititaion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
manual muscle test, handgrip, Brunnstrom stage, modified Ashworth scale,10m gait speed,Timed up and go test, Fugel-Myer Assessment(FMA), Wolf Motor Function Test(WMFT), SF36
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
repetitive transcranial magnetic stimulation
Interventions/Control_2
sham stimulation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients are in the post -stroke period over one year following onset.
(2)History of a single stroke only
(3)No cognitive disorders
(4)No depression
(5)No active physical and psychological disorders
Key exclusion criteria
(1)Seizures for the past year
(2)Current use of antiepileptic medications for the prevention of seizure
(3)Implanted medical device
(4)Intracranial magnetic material
(5)Pregnant or intented to be pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuji Kaji |
Organization
Tokushima university hospital
Division name
Department of Neurology
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-7207
kajkyoto@mbox.kyoto-inet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeuchi Toshiaki |
Organization
Tokushima university hospital
Division name
Department of Neurology
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-7207
Homepage URL
takeuchi.toshiaki@tokushima-u.ac.jp
Sponsor or person
Institute
Department of neurology, Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 10 | 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
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 13 | 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
| 2012 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010181
| 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 |
