UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009229 |
|---|---|
| Receipt number | R000010634 |
| Scientific Title | Juntendo Early Deep Brain Stimulation Trial (JuST) |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2019/11/06 15:24:45 |
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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 | Atsushi |
| Middle name | |
| Last name | Umemura |
Organization
Juntendo University
Division name
Department of Research and Therapeutics for Movement Disorders
Zip code
1130034
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3813-3111
g_oyama@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
1130033
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3813-3111
Homepage URL
g_oyama@juntendo.ac.jp
Sponsor or person
Institute
Department of Research and Therapeutics for Movement Disorders, Juntendo University
Institute
Department
Personal name
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
Juntendo University Faculty of Medicine
Address
Bunkyo-ku
Tel
0338133111
g_oyama@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
| 2012 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
10
Results
sustained
Results date posted
| 2019 | Year | 11 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
no enough data
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
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
| 2019 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010634
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
