UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014287 |
|---|---|
| Receipt number | R000016468 |
| Scientific Title | Research for objective evaluation of efficacy of anti-Parkinson's drug with repetitive transcranial magneticstimulation in Parkinson's disease |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2015/06/03 23:08:51 |
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Basic information
Public title
Research for objective evaluation of efficacy of anti-Parkinson's drug with repetitive transcranial magneticstimulation in Parkinson's disease
Acronym
objective evaluation of efficacy of anti-Parkinson's drug with repetitive transcranial magnetic stimulation
Scientific Title
Research for objective evaluation of efficacy of anti-Parkinson's drug with repetitive transcranial magneticstimulation in Parkinson's disease
Scientific Title:Acronym
objective evaluation of efficacy of anti-Parkinson's drug with repetitive transcranial magnetic stimulation
Region
| Japan |
Condition
Condition
Parkinson's disease.
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate relation between the effects of anti-Parkinson's drug and plastic changes in the motor cortex elicited by repetitive magnetic stimulation in Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitude of the motor evoked potentials(MEP)
UPDRS score
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients come two times separated by 1-8weeks. First time, patients before treatment or Off condition and at second time patients are On condition.
Before, repetitive magnetic stimulation for 30 min, MEPs and UPDRS are measured as the baseline activity. MEPs are also measured after rTMS for 1hours to evaluate cortical excitability change.
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
Parkinson's disease patient from whom we obtained informed consent
Key exclusion criteria
In patients with internal metal such as cardiac pace maker, drug delivery pump or DBS, cerebral stroke, brain injury, brain tumor, epilepsy, psychiatric disorder, pregnant females, or those contemplating pregnancy. And people whom the investigators evaluate as approved.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terao |
Organization
University of Tokyo Hospital
Division name
Neurology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-3815-5411
yterao-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Tanaka |
Organization
University of Tokyo Hospital
Division name
Neurology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-3815-5411
Homepage URL
ntanaka-kob@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Dinippon Sumitomo Pharma Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 06 | Month | 18 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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
| 2014 | Year | 06 | Month | 17 | Day |
Last modified on
| 2015 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016468
