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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009229
Receipt No. R000010634
Scientific Title Juntendo Early Deep Brain Stimulation Trial (JuST)
Date of disclosure of the study information 2012/11/01
Last modified on 2012/10/31

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Basic information
Public title Juntendo Early Deep Brain Stimulation Trial (JuST)
Acronym JuST trial
Scientific Title Juntendo Early Deep Brain Stimulation Trial (JuST)
Scientific Title:Acronym JuST trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of deep brain stimulation in early stage Parkinson's disease patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The Parkinson's Disease Questionnaire (PDQ-39)
Key secondary outcomes Unified Parkinoson's Disease Rating Scale (UPDRS) part I-IV, Modified Hoehn & Yahr stage, Beck Depression Inventory (BDI), Hamilton Rating Scale for Depression (HAMD), Montgomery-Asberg Depression Scale (MADRS), Zung Self-rating Depression Scale (SDS), Apathy scale (AS), Mini-Mental State Examination (MMSE), Frontal Assessment Battery (FAB), Japanese version of Montreal Cognitive Assessment (MoCA-J), Keio version Wisconsin card sorting test (KWCST), other adverse events (impulse control disorder, dopamine disregulation syndrome, dopamine agonist withdrawal syndrome, e.t.c.)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Combination of deep brain stimulation and best medical treatment
Interventions/Control_2 Best medical treatment
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Parkinson's disease patients ( UK brain bank Parkinson's disease diagnostic criteria, include familial PD) who are considering DBS.
2. Disease duration has to be >/=3 years.
3. Declined uptake in MIBG cardiac scintigraphy (Early<1.4 and/or delay<1.4)
4. L-DOPA-sensitivity (of at least 30% in UPDRS-III)
5. No motor fluctuation (wearing off, dyskinesia) or presence of fluctuations and/or dyskinesias for no more than 5 years.
6. No dementia and/or active psychiatric problem.
7. No contra-indication for brain surgery.
8. Cardiac pacemaker should not be implanted.
9. Patients with tolerance for general
anesthesia
10. Age>/=20, <75
11. Patients can understand informed consent.
Key exclusion criteria 1. Pregnancy
2. Patients who cannot understand informed consent.
3. Patients who are participating other clinical trial.
4. Patients who are considered not appropriate for the study by investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Umemura
Organization Juntendo University
Division name Department of Research and Therapeutics for Movement Disorders
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL +81-3-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Umemura
Organization Juntendo University
Division name Department of Research and Therapeutics for Movement Disorders
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL +81-3-3813-3111
Homepage URL
Email

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

Funding Source
Organization Department of Research and Therapeutics for Movement Disorders, Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 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
2012 Year 11 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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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

Management information
Registered date
2012 Year 10 Month 31 Day
Last modified on
2012 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010634

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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