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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028983
Receipt No. R000033164
Scientific Title EMG triggered repetitive transcranial magnetic stimulation for patients with stroke
Date of disclosure of the study information 2017/09/04
Last modified on 2017/09/04

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Basic information
Public title EMG triggered repetitive transcranial magnetic stimulation for patients with stroke
Acronym EMG triggered rTMS
Scientific Title EMG triggered repetitive transcranial magnetic stimulation for patients with stroke
Scientific Title:Acronym EMG triggered rTMS
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to assess the effect of EMG triggered repetitive transcranial magnetic stimulation on the upper extremity function in patients with stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Box and Block test before and after intervention
Key secondary outcomes Peg test
MEP
Fugl Meyer motor function

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 EMG triggered rTMS
Interventions/Control_2 rTMS
Interventions/Control_3 Sham TMS
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Time since stroke onset is more tha 5 monts
Patient can understand the aim of the study
Stroke impairment Assessment Set sensory score is 1 or more
Stroke impairment Assessment Set motor score is 1B or more
Passive range of motion in finger extension is 0 degree or more
Participant can walk independently
Key exclusion criteria Severe cardio-pulmonary disease
Severe Hypertension
Fever
Severe liver dysfunction
Severe renal dysfunction
Severe Orthopedics problems
Severe metabolic disease
VP shunt, clipping, metal in the body
Contraindication of transcranial magnetic stimulation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Fujiwara
Organization Juntendo University
Division name Rehabilitation Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo 113-8421
TEL 03-3813-3111
Email tofuji@xc5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Fujiwara
Organization Juntendo University
Division name Rehabilitation Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo 113-8421
TEL 03-3813-3111
Homepage URL
Email tofuji@xc5.so-net.ne.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email

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
2017 Year 09 Month 04 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
2017 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 17 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 04 Day
Last modified on
2017 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033164

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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