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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022511
Receipt No. R000025950
Scientific Title A study of repetitive transcranial magnetic stimulation for functional recovery of stroke patients
Date of disclosure of the study information 2016/06/01
Last modified on 2019/06/01

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Basic information
Public title A study of repetitive transcranial magnetic stimulation for functional recovery of stroke patients
Acronym A study of repetitive transcranial magnetic stimulation for functional recovery of stroke patients
Scientific Title A study of repetitive transcranial magnetic stimulation for functional recovery of stroke patients
Scientific Title:Acronym A study of repetitive transcranial magnetic stimulation for functional recovery of stroke patients
Region
Japan

Condition
Condition stroke
Classification by specialty
Medicine in general Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 functional recovery of hemiparetic stroke patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Finger tapping speed, walking speed (3m Timed Up-and-go test)
Key secondary outcomes FIM (Functional Independence Measure)
SIAS (Stroke Impairment Assessment Set)
Brunnstrom stage
Manual muscle testing
Finger pinch force

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1Hz-repetitive transcranial magnetic stimulation (max. 2000 pulses/session; stimulus intensity, 90% resting motor threshold; target, primary motor cortex contralateral to the paretic side)
1 session/week, 4 weeks
Real stimualtion vs. placebo
Cross-over design
Stimulator; Magstim Rapid (The Magstim Company, UK)(Code; 36902000)
Interventions/Control_2 placebo (the stimulation coil is detached apart from the sculp or tilted 45-90 degrees to the tangential plane of the sculp)
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) chronic-stage hemiparetic stroke patient (6 months or more after onset)
2) written informed consent
3) outpatient
Key exclusion criteria 1) severe medical illness
2) permanent pacemaker, cerebral aneurysm clipping
3) epilepsy
4) consciousness disturbance, advanced dementia or communicative difficulties
5) any other conditions unsuitable to the study judged by doctor(s)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Katayama
Organization Asahikawa Medical University
Division name First Department of Internal Medicine
Zip code
Address 2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL +81-(0)166-68-2442
Email katataka@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Katayama
Organization Asahikawa Medical University
Division name First Department of Internal Medicine
Zip code
Address 2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL +81-(0)166-68-2442
Homepage URL
Email katataka@asahikawa-meda.c.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 06 Month 01 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
2016 Year 05 Month 29 Day
Date of IRB
2016 Year 05 Month 27 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
2019 Year 06 Month 01 Day
Date trial data considered complete
2019 Year 06 Month 01 Day
Date analysis concluded
2019 Year 06 Month 01 Day

Other
Other related information This study is terminated bacause
1) the patient number did not reach the target
and
2) the representative researcher will move to other institution

Management information
Registered date
2016 Year 05 Month 29 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025950

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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