UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022511 |
|---|---|
| Receipt number | 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 18:36:03 |
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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
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
katataka@asahikawa-meda.c.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025950
