UMIN-CTR Clinical Trial

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
Email	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
Email	sako19920707@gmail.com

Sponsor
Institute	Motoyama Rehabilitation Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043781