UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019733 |
|---|---|
| Receipt number | R000022788 |
| Scientific Title | Effects of repetitive transcranial magnetic stimulation on cortical plasticity |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2021/05/20 10:20:11 |
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Basic information
Public title
Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Acronym
Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Scientific Title
Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Scientific Title:Acronym
Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Region
| Japan |
Condition
Condition
healthy subjects, movement disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of repetitive transcranial magnetic stimulation on cortical plasticity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Primary outcome measure is cortical plasticity assessed by neurophysiological and behavioural measures up to 3 hours after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Real repetitive transcranial magnetic stimulation within 30 min for single session, repeated up to 10 sessions.
Interventions/Control_2
Control repetitive transcranial magnetic stimulation within 30 min for single session, repeated up to 10 sessions.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy control and patients with movement disorders
Key exclusion criteria
The only absolute contraindication to TMS/rTMS is the presence of metallic hardware in close contact to the discharging coil (such as cochlear implants, or an Internal Pulse Generator or medication pumps). In such instances there is a risk of inducing
malfunctioning of such implanted devices.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Hamada |
Organization
the University of Tokyo Hospital
Division name
Neurology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8672
mhamada-tky@umin.net
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Hamada |
Organization
the University of Tokyo Hospital
Division name
Neurology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8672
Homepage URL
mhamada-tky@umin.net
Sponsor or person
Institute
Departemtn of Neurology, the University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Ethics Committee, Graduate School of Medicine and Faculty of Medicine The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
03-3812-2111(ext.20818)
ethics@m.u-tokyo.ac.jp
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
| 2015 | Year | 11 | Month | 10 | 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
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022788
