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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007594
Receipt No. R000008966
Scientific Title The efficacy of post-stroke rTMS on early stage rehabilitation patients
Date of disclosure of the study information 2012/03/28
Last modified on 2013/03/29

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Basic information
Public title The efficacy of post-stroke rTMS on early stage rehabilitation patients
Acronym The efficacy of post-stroke rTMS on early stage rehabilitation patients
Scientific Title The efficacy of post-stroke rTMS on early stage rehabilitation patients
Scientific Title:Acronym The efficacy of post-stroke rTMS on early stage rehabilitation patients
Region
Japan

Condition
Condition Stroke
Classification by specialty
Medicine in general Neurology Neurosurgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of repetitive transcranial magnetic stimulation of the primary motor cortex in early stage post-stroke patients undergoing rehabilitation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptoms, finger taping, heat & cold sense(pathway), SIAS-M, Fugl-Meyer,Brunn-strom, handgrip, 10m gait speed test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) 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 real repetitive transcranial magnetic stimulation
Interventions/Control_2 sham stimulation
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 (1) Post-stroke patients undergoing early stage rehablitaiton in the specified facilities.
(2) Patients with impared motor function who are in the post-stroke period between 10 days to 8 weeks following onset.
(3) No cognitive disorders, aphasia, psychiatric disorder, higher brain dysfunction or desire for suicide
(4) patients who can undergo the appropriate evaluations
(5) over 20 years old
(6) informed consent
Key exclusion criteria (1) metal implant on the head
(2) heart pacing, drug infusion pump
(3) severe heart diseases
(4) Major cerebral infarction, head traum, epilepsy, brain tumor
(5) pregnancy
(6) the patients who was excluded by doctors
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Youichi Saitoh
Organization Osaka University Graduate School of Medicine
Division name Department of Neurosurgery/ Department of Neuromodulation and Neurosurgery
Zip code
Address Yamadaoka 2-2, Suita, Osaka 565-0871
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Neurosurgery/ Department of Neuromodulation and Neurosurgery
Zip code
Address Yamadaoka 2-2, Suita, Osaka 565-0871
TEL 06-6879-3652
Homepage URL
Email

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
2012 Year 03 Month 28 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 Completed
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2013 Year 01 Month 14 Day
Date of closure to data entry
2013 Year 02 Month 14 Day
Date trial data considered complete
2013 Year 02 Month 18 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 28 Day
Last modified on
2013 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008966

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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