UMIN-CTR Clinical Trial

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
Email	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
Email	mano@neuromod.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University ospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020680