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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016467
Receipt No. R000019048
Scientific Title Study for DBS programing based on local field potential from DBS lead during surgery in Parkinson disease
Date of disclosure of the study information 2015/02/09
Last modified on 2020/01/13

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Basic information
Public title Study for DBS programing based on local field potential from DBS lead during surgery in Parkinson disease
Acronym DBS programing based on local field potential
Scientific Title Study for DBS programing based on local field potential from DBS lead during surgery in Parkinson disease
Scientific Title:Acronym DBS programing based on local field potential
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to explore more effective DBS programing based on local field potential in Parkinson disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison with the best stimulation parameter and local field potential analysis
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with Parkinson disease who undergo DBS surgery in Juntendo University Hospital
2. Patients who can understand informed consent.
Key exclusion criteria Patients assessed by the investigator to be ineligible for the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Umemura
Organization Juntendo University
Division name Department of Research and Therapeutics for Movement Disorders
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL 03-3813-3111
Email aumemura@juntendo.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Umemura
Organization Juntendo University
Division name Department of Research and Therapeutics for Movement Disorders
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL 03-3813-3111
Homepage URL
Email aumemura@juntendo.ac.jp

Sponsor
Institute Department of Research and Therapeutics for Movement Disorders, Juntendo University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Juntendo University
Address 2-1-1 Hongo, Bunkyo, Tokyo
Tel 03-3813-3111
Email 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 順天堂大学運動障害疾患病態研究治療講座 / Department of Research and Therapeutics for Movement Disorders, Juntendo University

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 09 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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 30 Day
Date of IRB
2016 Year 01 Month 28 Day
Anticipated trial start date
2016 Year 02 Month 09 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Local field potential recorded in DBS surgery is analyzed and compared with the best stimulation parameter

Management information
Registered date
2015 Year 02 Month 07 Day
Last modified on
2020 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019048

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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