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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000010523
Receipt No. R000012302
Scientific Title The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Date of disclosure of the study information 2013/04/17
Last modified on 2016/04/18

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Basic information
Public title The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Acronym The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Scientific Title The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Masaru Yokoe
Organization Osaka university
Division name Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Zip code
Address 2-1 Yamadaoka, Suita, Osaka
TEL +81-6-6879-3571
Email neurosaitoh@mbk.nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Yokoe
Organization Osaka university
Division name Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Suspended
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012302

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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