UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019521 |
|---|---|
| Receipt number | 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 09:32:35 |
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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
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
nabe@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022578
