UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026142 |
|---|---|
| Receipt number | R000030049 |
| Scientific Title | Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2017/02/15 14:13:14 |
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Basic information
Public title
Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Acronym
Unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Scientific Title
Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Scientific Title:Acronym
Unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment efficacy of repetitive transcranial magnetic stimulation for unilateral spatitial neglect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CBS(Catherin Bergego Scale), Line Bisection Test, Cancellation task BIT(Behavioural inattention test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
7 sessions of 1Hz, 500 pllse repetiteve transcranial magnetic stimulation(rTMS)every other day for two weeks
Interventions/Control_2
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
| 70 | days-old | <= |
Age-upper limit
| 180 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Unilateral neglect is detected among patients with recover phase stroke after onset 70 days.
Key exclusion criteria
Case with a cerebral aneurysm clipping technique and pacemaker implantation, an epilepsy history and the dementia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamiko Sato |
Organization
Fukui general hospital
Division name
Rehabilitaion department
Zip code
Address
58-16-1, Egami-cho, Fukui-shi
TEL
0776-59-1300
satomokonoori@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamiko Sato |
Organization
Fukui general hospital
Division name
Rehabilitaion department
Zip code
Address
58-16-1, Egami-cho, Fukui-shi
TEL
0776-59-1300
Homepage URL
satomokonoori@yahoo.co.jp
Sponsor or person
Institute
Fukui general hospital
Institute
Department
Personal name
Funding Source
Organization
Fukui general hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030049
