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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009996
Receipt No. R000011704
Scientific Title MRI Measurement of Lead Location for Suboptimal Outcomes after Deep Brain Stimulation
Date of disclosure of the study information 2013/02/27
Last modified on 2020/08/14

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Basic information
Public title MRI Measurement of Lead Location for
Suboptimal Outcomes after Deep Brain Stimulation
Acronym MRI trouble shooting for DBS study (MRI-DBS study)
Scientific Title MRI Measurement of Lead Location for
Suboptimal Outcomes after Deep Brain Stimulation
Scientific Title:Acronym MRI trouble shooting for DBS study (MRI-DBS study)
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy and safety of measuring lead location by brain MRI for patients with suboptimal clinical efficacy of deep brain stimulation (DBS) and to assess efficacy of repositioning or adding DBS lead(s).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The Parkinson's Disease Questionnaire (PDQ-39)
Key secondary outcomes 1.Unified Parkinoson's Disease Rating Scale (UPDRS) part I, II, IV
2.UPDRS-III (on/off stimulation, on/off medication)
3. Impedance
4.threshoulds for efficacy and side effect of DBS
5. Beck Depression Inventory (BDI)
6. Hamilton Rating Scale for Depression (HAMD)
7. Montgomery-Asberg Depression Scale (MADRS)
8. Zung Self-rating Depression Scale (SDS)
9. Apathy scale (AS)
10. Mini-Mental State Examination (MMSE)
11. Frontal Assessment Battery (FAB)
12.Japanese version of Montreal Cognitive Assessment (MoCA-J)
13.Keio version Wisconsin card sorting test (KWCST)
14. other complications

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 MRI
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
99 years-old >
Gender Male and Female
Key inclusion criteria Include either 1 or 2:
1. Patients with suboptimal clinical efficacy after DBS therapy.
2. Patients who cannot increase DBS settings due to stimulation induced side effects.
Key exclusion criteria Exclusion criteria are following.
1. Pregnant women and, nursing mothers
2. Patients who have cardiac pacemaker.
3. Patients who cannot understand the concept of this study or who cannot obtain written consent.
4. Patients who are assumed not to be appropriate candidate for this study by investigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Shimo
Organization Juntendo University
Division name Department of Research and Therapeutics for Movement Disorders
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-0033
TEL +81-3-3813-3111-
Email yshimo@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Genko Oyama
Organization Juntendo University
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL +81-3-3813-3111
Homepage URL
Email g_oyama@jutendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 順天堂大学附属順天堂医院(東京)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 27 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
2013 Year 02 Month 04 Day
Date of IRB
2013 Year 02 Month 01 Day
Anticipated trial start date
2013 Year 02 Month 04 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 07 Day
Last modified on
2020 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011704

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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