UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Title of the study (Brief title)	The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Region	Japan

Condition
Condition	Parkinsonism
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of repetitive transcranial magnetic stimulation over the primary motor area and the supplementary motor area, the dorsolateral prefrontal cortex for Parkinsonism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Unified Parkinson's Disease Rating Scale(UPDRS),Parkinson's Disease Questionnaire-39(PDQ-39)
Key secondary outcomes	5-point scale for daily life and tremor, Apathy scale,Montogomery and Asberg depression rating scale,Self-rating Depression Scale(SDS),analyzed parameters of finger tapping by magnetic sensor,Timed up and go test

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Repetitive transcranial magnetic stimulation over the primary motor area
Interventions/Control_2	Repetitive transcranial magnetic stimulation over the supplementary motor area
Interventions/Control_3	Repetitive transcranial magnetic stimulation over the DLPFC
Interventions/Control_4	Sham stimulation
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Diagnosed as Parkinsonism (2)Patients who consented to keep drug and living conditions during the study (3) No cognitive disorders, aphasia, psychiatric disorder, higher brain dysfunction (4) the patients who can write questionare (5) over 20 years old (6) Those who give us informed consent to participate in the present study after detailed explanation of the study
Key exclusion criteria	(1) No implantation of metal in head, except in the mouth (2) Those having heart pacemaker or drug infusion pomp (3) Those having heart pacemaker or severe heart diseases (4) Those having the deep brain stimulation or the spinal cord stimulation (5)Major cerebral infarction, head traum, epilepsy, brain tumor (6) Pregnant or intend to be pregnant (7) the patients who are excluded by doctors
Target sample size	20

Research contact person
Name of lead principal investigator	Masaru Yokoe
Organization	Osaka university
Division name	Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Address	2-1 Yamadaoka, Suita, Osaka
TEL	+81-6-6879-3571
Email	neurosaitoh@mbk.nifty.com

Public contact
Name of contact person	Masaru Yokoe
Organization	Osaka university
Division name	Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Address	2-1 Yamadaoka, Suita, Osaka
TEL	+81-6-6879-3571
Homepage URL
Email	myokoe@neurol.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University, Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 04 Month 17 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2013 Year 01 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 14 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 04 Month 15 Day
Date analysis concluded	2015 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 17 Day
Last modified on	2016 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012302