UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017888 |
|---|---|
| Receipt number | R000020680 |
| Scientific Title | Influence of repetitive transcranial magnetic stimulation of cerebral cortex on eye movement of Parkinson's disease and syndrome |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2019/06/17 09:56:47 |
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Basic information
Public title
Influence of repetitive transcranial magnetic stimulation of cerebral cortex on eye movement of Parkinson's disease and syndrome
Acronym
Influence of rTMS of brain on eye movement of Parkinson's syndrome
Scientific Title
Influence of repetitive transcranial magnetic stimulation of cerebral cortex on eye movement of Parkinson's disease and syndrome
Scientific Title:Acronym
Influence of rTMS of brain on eye movement of Parkinson's syndrome
Region
| Japan |
Condition
Condition
Parkinson's disease and syndrome
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Parkinson's disease and syndrome, motor symptoms are improved by rTMS of cerebral cortex. We will analyze the improvements of eye movement of them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of improvement of eye movements
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
repetitive transcranial magnetic stimulation of bilateral motor cortex
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, Parkinson syndrome
Key exclusion criteria
1 cannot sit for an hour
2 cognitive disorder MMSE under 24 points
3 hallucination
4 astigmatism
5 narrowing of visual field
6 intake of drug which may induce Parkinsonism within 6 months
7 combination with other neuro-mascular diseases
8 past history of cerebro-vascular disease and infectious diseases of CNS
9 cerebral infarction in basal ganglia and brain stem with MRI
10 metal in the patient's head without mouse
11 patients receiving pace maker and drug delivery pump
12 severe heart diseases
13 patients receiving DBS and SCS
14 cerebral infarction with stem arteries, brain tumors, traumatic brain injuries, epilepsy
15 pregnant and women who plan to be pregnant
16 patients who the doctors consider inappropriate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Youichi |
| Middle name | |
| Last name | Saitoh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neuromodulation and Neurosurgery
Zip code
5650871
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6210-8435
saitoh@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoo |
| Middle name | |
| Last name | Mano |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neuromodulation and Neurosurgery
Zip code
5650871
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6210-8435
Homepage URL
mano@neuromod.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University ospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Ethics Commitee
Address
2-2 Yamadaoka, Suita, Osaka, Japan , Osaka
Tel
06-6879-8290
shiken@hp-crc.med.osaka-u.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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020680
