UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038420 |
|---|---|
| Receipt number | R000043781 |
| Scientific Title | Effect of high-frequency rTMS on patients with leg paralysis |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2019/10/29 11:06:49 |
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Basic information
Public title
Effect of high-frequency rTMS on patients with leg paralysis
Acronym
Effect of high-frequency rTMS on patients with leg paralysis
Scientific Title
Effect of high-frequency rTMS on patients with leg paralysis
Scientific Title:Acronym
Effect of high-frequency rTMS on patients with leg paralysis
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effects of high frequency repetitive transcranial magnetic stimulation on lower limb paralysis in stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brunnstrom recovery stage
Fugl-Meyer assessment
Modified Ashworth Scale
Functional Reach Test
Timed Up and Go test
10m gait
Functional balance scale
BESTEST
Functional Ambulation Categories
Functional Independence Measure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-frequency repetitive transcranial magnetic stimulation on lower limb area
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The lesion does not extend to the cerebral cortex
In the case of cerebral hemorrhage after 0 days after onset, hematoma is absorbed
10m walk is possible by walking alone (balance ability is not included. Contact assistance is also possible)
No history of epilepsy or seizures
Metals close to the stimulation site (stimulators such as cochlear implants, magnetic clips, deep brain stimulation and vagus nerve stimulation), without a cardiac pacemaker
Intracranial titanium products, or magnetically mounted dentures, without implants
Intracranial lesions at risk for seizures
There is no
Those who have not taken medications that lower the seizure threshold (such as tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine).
Those who are not complicated by serious physical illness during pregnancy, abuse, withdrawal of alcohol, caffeine or stimulant.
Those who do not have cognitive decline or higher brain damage that may affect or be dangerous in the intervention of this study
Key exclusion criteria
The lesion does not extend to the cerebral cortex
In the case of cerebral hemorrhage after 0 days after onset, hematoma is absorbed
10m walk is possible by walking alone (balance ability is not included. Contact assistance is also possible)
No history of epilepsy or seizures
Metals close to the stimulation site (stimulators such as cochlear implants, magnetic clips, deep brain stimulation and vagus nerve stimulation), without a cardiac pacemaker
Intracranial titanium products, or magnetically mounted dentures, without implants
Intracranial lesions at risk for seizures
There is no
Those who have not taken medications that lower the seizure threshold (such as tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine).
Those who are not complicated by serious physical illness during pregnancy, abuse, withdrawal of alcohol, caffeine or stimulant.
Those who do not have cognitive decline or higher brain damage that may affect or be dangerous in the intervention of this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Sakoda |
Organization
Medical Corporation Motoyama rehabilitation
Hospital
Division name
rehabilitation
Zip code
6580015
Address
7-7-15 motoyamaminami-cho,hidgashinada-ku kobe-shi hyogo-ken
TEL
0784128080
sako19920707@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Sakoda |
Organization
Motoyama Rehabilitation Hospital
Division name
rehabilitation
Zip code
6580015
Address
7-7-15 motoyamaminami-cho,hidgashinada-ku kobe-shi hyogo-ken
TEL
0784128080
Homepage URL
sako19920707@gmail.com
Sponsor or person
Institute
Motoyama Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Motoyama Rehabilitation Hospital
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
Motoyama Rehabilitation Hospital
Address
7-7-15 motoyamaminami-cho,hidgashinada-ku kobe-shi hyogo-ken
Tel
0784128080
sako19920707@gmail.com
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
| 2021 | Year | 07 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043781
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
