UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026716 |
|---|---|
| Receipt number | R000030670 |
| Scientific Title | Effect of repetitive transcranial magnetic stimulation for the treatment of spinocerebellar ataxia cases |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2018/10/09 12:41:20 |
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Basic information
Public title
Effect of repetitive transcranial magnetic stimulation for the treatment of spinocerebellar ataxia cases
Acronym
Effect of repetitive transcranial magnetic stimulation for spinocerebellar ataxias
Scientific Title
Effect of repetitive transcranial magnetic stimulation for the treatment of spinocerebellar ataxia cases
Scientific Title:Acronym
Effect of repetitive transcranial magnetic stimulation for spinocerebellar ataxias
Region
| Japan |
Condition
Condition
spinocerebellar ataxia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of repetitive transcranial magnetic stimulation for spinocerebellar ataxia cases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
SARA, ICARS, gait evaluation, stabilometry(before treatment, at 1, 2, 3 weeks, 2, 4, 6, 8, 10 and 12 months after treatment)
Key secondary outcomes
MMSE, HDS-R(before treatment, at 3 weeks, 6 and 12 months after treatment)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
magstim rapid system MRS1000/30
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Spinocerebellar ataxia cases who agreed to participate in this study
Key exclusion criteria
Patients disagreed to this study
Who have been regarded to be inappropriate to participate in the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Miyaue |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Neurology and Clinical Pharmacology
Zip code
Address
454, shitsukawa Tohon, Ehime, Japan
TEL
089-960-5095
miyaue@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Miyaue |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Neurology and Clinical Pharmacology
Zip code
Address
454, shitsukawa Tohon, Ehime, Japan
TEL
089-960-5095
Homepage URL
miyaue@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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 | 03 | Month | 27 | 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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030670
