UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031908
Receipt number R000036137
Scientific Title A prospective study examining the role of medical imaging in the management of Parkinson's disease
Date of disclosure of the study information 2018/04/01
Last modified on 2022/10/11 10:50:40

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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 or person

Institute

Department of Neurology
Juntendo University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name