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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028495
Receipt No. R000032410
Scientific Title Effectiveness of repetitive transcranial magnetic stimulation for upper limb hemiparesis after stroke
Date of disclosure of the study information 2017/08/05
Last modified on 2019/09/13

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Basic information
Public title Effectiveness of repetitive transcranial magnetic stimulation for upper limb hemiparesis after stroke
Acronym Effectiveness of r-TMS
Scientific Title Effectiveness of repetitive transcranial magnetic stimulation for upper limb hemiparesis after stroke
Scientific Title:Acronym Effectiveness of r-TMS
Region
Japan

Condition
Condition stroke
Classification by specialty
Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effectiveness of repetitive transcranial magnetic stimulation for upper limb hemiparesis after stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1 Simple Test for Evaluating Hand Function(STEF)

2 Fugl-Meyer motor assessment(FMA)
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 TMS
11days
20minutes per time
1 or 2 times per day
total 20 times
Interventions/Control_2 sham
11days
20minutes per time
1 or 2 times per day
total 20 times
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

Not applicable
Gender Male and Female
Key inclusion criteria stroke patients with upper limb hemiparesis passed more than one year after the onset
Key exclusion criteria patients with bilateral lesion
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromichi Ando
Organization Kakamigahara Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
Address 6-8-2, Unumayamazaki-cho, Kakamigahara city, Gifu
TEL 058-384-8485
Email andou@seidoukai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Takahashi
Organization Kakamigahara Rehabilitation Hospital
Division name Medical affairs section
Zip code
Address 6-8-2, Unumayamazaki-cho, Kakamigahara city, Gifu
TEL 058-384-8485
Homepage URL
Email iryoukaigo@seidoukai.or.jp

Sponsor
Institute Kakamigahara Rehabilitation Hospital
Institute
Department

Funding Source
Organization Kakamigahara Rehabilitation Hospital
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2017-M034
Org. issuing International ID_1 Aichi Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 05 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 Terminated
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
2017 Year 07 Month 27 Day
Anticipated trial start date
2017 Year 07 Month 27 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 02 Day
Last modified on
2019 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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