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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019521
Receipt No. R000022578
Scientific Title Analyses of relationship between medication and resting functional MRI findings in patients with Parkinson's disease
Date of disclosure of the study information 2015/10/27
Last modified on 2017/04/28

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Basic information
Public title Analyses of relationship between medication and resting functional MRI findings in patients with Parkinson's disease
Acronym rsfMRI findings in PD
Scientific Title Analyses of relationship between medication and resting functional MRI findings in patients with Parkinson's disease
Scientific Title:Acronym rsfMRI findings in PD
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of medication on the resting functional MRI findings in Parkinson's disease
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between medication and resting state functional MRI findings
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of resting state fMRI findings after medication
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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 medication for parkinsonian symptom
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 patients who fulfill the diagnostic criteria of UK brain bank
Key exclusion criteria PD patients with contraindication of MRI
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Watanabe
Organization Nagoya University
Division name Brain and mind research center
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL 052-741-2111
Email nabe@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Watanabe
Organization Nagoya University
Division name Brain and mind research center
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL 052-741-2111
Homepage URL
Email nabe@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university
Institute
Department

Funding Source
Organization MEXT (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2015 Year 10 Month 27 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 Data analyses are on-going.
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 Open public recruiting
Date of protocol fixation
2013 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is case control study. We enroll the patients who fulfill the Brain bank diagnostic criteria. We evaluate clinical examination including MDS-UPDRS, MRI, and MEG etc.

Management information
Registered date
2015 Year 10 Month 27 Day
Last modified on
2017 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022578

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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