UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018819 |
|---|---|
| Receipt number | R000021767 |
| Scientific Title | Effect of repetitive transcranial magnetic stimulation in patients with acute capsular infarction |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2015/09/05 01:08:00 |
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Basic information
Public title
Effect of repetitive transcranial magnetic stimulation in patients with acute capsular infarction
Acronym
rTMS on acute capsular infarction
Scientific Title
Effect of repetitive transcranial magnetic stimulation in patients with acute capsular infarction
Scientific Title:Acronym
rTMS on acute capsular infarction
Region
| Japan |
Condition
Condition
acute capsular infarction
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of rTMS on upper limb function in patients with acute capsular infarction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer assessmen,
Stroke Impairment Assessment Set,
Functional Independence Measure,
modified Ashworth scale,
grip power,
measured before, 2 weeks after, 4 weeks after, 6 weeks after, and 8 weeks after rTMS.
Key secondary outcomes
MEP
SPECT
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1 Hz rTMS on unaffected motor cortex (hand area), 1200 pulses/day x 5 days at 110% of motor threshold intensity using Magstim Rapid stimulator.
Interventions/Control_2
iTBS rTMS on affected motor cortex (hand area), 600 pulses/day x 5days at 80% motor threshold intensity using Magstim Rapid stimulator.
Interventions/Control_3
iTBS pattern sham rTMS on affected motor cortex (hand area), 600 pulses/day x 5 days at 80% motor threshold intensity (across the 5 cm thick piece of wood).
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
Hemiparesis due to acute capsular infarction
Key exclusion criteria
Patients with contraindication of rTMS
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Johkura |
Organization
Yokohama Brain and Spine Center
Division name
Department of Neurology
Zip code
Address
1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL
045-753-2500
ke00-johkura@city.yokohama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Johkura |
Organization
Yokohama Brain and Spine Center
Division name
Department of Neurology
Zip code
Address
1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL
045-753-2500
Homepage URL
ke00-johkura@city.yokohama.jp
Sponsor or person
Institute
Yokohama Brain and Spine Center
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
横浜市立脳卒中・神経脊椎センター Yokohama Brain and Spine Center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2015 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021767
