UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study examining the role of medical imaging in the management of Parkinson's disease
Acronym	A prospective study examining the role of medical imaging in the management of Parkinson's disease
Scientific Title	A prospective study examining the role of medical imaging in the management of Parkinson's disease
Scientific Title:Acronym	A prospective study examining the role of medical imaging in the management of Parkinson's disease
Region	Japan

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

Objectives
Narrative objectives1	In the management of Parkinson's disease (PD), it is useful to perform a detailed examination of therapeutic intervention and its outcome, and determine whether the outcome correlates with imaging findings. The purpose of the study is to examine changes in PD symptoms following the therapeutic intervention, and determine whether they are associated with imaging findings obtained prior to the intervention. The goal of the study is to investigate the utility of medical imaging in subsequent therapeutic decision making.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between PD symptom index before and after a therapeutic intervention.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are going to receive DAT at Juntendo University
Key exclusion criteria	Patients who are not suitable for the trial judged by PI.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Shimo
Organization	Juntendo University
Division name	Department of neurology
Zip code	113-8421
Address	2-1-1 Hongo Bunkyoku Tokyo
TEL	0338133111
Email	yshimo@juntendo.ac.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Shimo
Organization	Juntendo University
Division name	Department of Neurology
Zip code	113-8421
Address	2-1-1 Hongo Bunkyoku Tokyo
TEL	033813311
Homepage URL
Email	yshimo@juntendo.ac.jp

Sponsor
Institute	Department of Neurology Juntendo University
Institute
Department

Funding Source
Organization	Department of Neurology Juntendo University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo University
Address	2-1-1 Hongo Bunkyo-ku Tokyo
Tel	0338133111
Email	hongo-rinri@juntendo.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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 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	Preinitiation
Date of protocol fixation	2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	It is before starting recruitment.

Management information
Registered date	2018 Year 03 Month 26 Day
Last modified on	2022 Year 10 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036137