UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028495 |
|---|---|
| Receipt number | 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 17:05:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
iryoukaigo@seidoukai.or.jp
Sponsor or person
Institute
Kakamigahara Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032410
